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Comparison of outcomes by ASGE grade of complexity |
The median time of completion was significantly shorter (20.0 vs. 35.0 minutes;
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Comparison of outcomes by ASGE grade of complexity (n = 536)
| ASGE, American Society for Gastrointestinal Endoscopy; ERCP, endoscopic retrograde cholangiopancreatography.15 cases (2.9 %) were duodenoscope-based procedures not included in the ASGE grading system.Excludes one crossover case that did not have an ASGE grade.
The median rating of overall satisfaction with the performance of the single-use duodenoscope was 8.0 for cases with both ASGE grades 1 or 2 and ASGE grades 3 or 4 (
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Comparison of outcomes for expert versus less expert endoscopists |
ERCPs performed by expert and less expert endoscopists were similar with respect to completion rate (96.3 % [444/461] vs. 94.4 % [85/90], respectively;
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Comparison of outcomes by endoscopist level of experience. | ERCP, endoscopic retrograde cholangiopancreatography. | PMC10684334 |
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Comparison of outcomes by prior sphincterotomy |
On comparison with cases with at least one prior sphincterotomy, cases with no prior sphincterotomy had a higher median total procedural time (25.0 vs. 21.0 minutes;
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Related serious adverse events |
Of the 551 enrolled patients, 43 (7.8 %, 95 %CI 5.7 %–10.4 %) experienced at least one SAE related to the device or procedure within a median (range) of 1 (0–28) days post-procedure (
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Serious adverse events that occurred by 30 days after ERCP (n = 551 total). | hemorrhage, post-ERCP pancreatitis, perforation, COPD | ADVERSE EVENTS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, COPD, HEMORRHAGE, ACUTE PANCREATITIS, DILATION | PEPFatal acute pancreatitisERCP, endoscopic retrograde cholangiopancreatography; PEP, post-ERCP pancreatitis; COPD, chronic obstructive pulmonary disease.Each patient had one or more of the listed serious adverse events; rows are not mutually exclusive.The overall rate of related SAEs that were fatal in our study was 0.5 % (3/551; 95 %CI 0.11 %–1.6 %). These included one case of acute pancreatitis occurring 16 days after ERCP that was fatal on day 70, one fatal hemorrhage from the papilla after balloon dilation, and one fatal perforation associated with sphincteroplasty. | PMC10684334 |
Discussion | infection | INFECTION |
In this largest global study of a single-use duodenoscope, endoscopists with varying levels of experience had high procedural success in ERCPs, one-third of which were high complexity cases. The median performance ratings were high for this device. SAEs were in the expected range, based on the published safety data for reusable duodenoscopes. Consistent with two previously published clinical studies
In an effort to eliminate the potential for contamination or infection associated with ineffective reprocessing of reusable duodenoscopes, the FDA have cleared duodenoscopes with disposable components
Ecological sustainability is an important issue for both single-use and reusable devices. For example, a 2023 publication focused on manufacturing-associated carbon dioxide emissions reported that performing ERCP with single-use duodenoscopes releases a carbon dioxide equivalent that is 24–47 times greater than with a reusable duodenoscope or a reusable duodenoscope with disposable endcaps
The results from the current study are consistent with those from previous studies of the single-use duodenoscope
All ERCP-associated SAEs are concerning and continual efforts must be made to minimize them. We compared the safety results in the current study with the published safety data for procedures performed with reusable duodenoscopes. The largest analysis of ERCP safety available is from Andriulli et al.
These findings suggest that, when used by a group of endoscopists with a predominantly expert level of experience, the single-use duodenoscope has a comparable safety profile to reusable duodenoscopes. The comparable rate of infection also shows that endogenous infection can still occur with when using a single-use duodenoscope, so the procedure-associated infection rate is not guaranteed to be lower than the rate for reusable duodenoscopes.
Our study has several strengths, limitations, and considerations for study interpretation. This was a multinational observational study including a large number of scheduled ERCP cases with a range of complexity performed by endoscopists at varying levels of experience, including 30-day safety follow-up. Limitations include the lack of randomization and the absence of a control group. Although patients were consecutively screened, the 68 % who were eligible to participate in this study may not be typical of patients at all endoscopy centers. Specific reasons why 10 screened patients were excluded for “concern over safety of subject if study duodenoscope was used for procedure’’ were not documented. Of note, several investigators participated in the development of the single-use duodenoscope
In conclusion, academic endoscopists used the first marketed single-use duodenoscope to successfully complete a large number of scheduled ERCP procedures with a range of complexity in a diverse patient population. Consistent with past studies, the device showed good performance and an SAE rate comparable with the published estimates for reusable duodenoscopes. | PMC10684334 |
Data sharing |
The data, analytic methods, and study materials for this study may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (
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References | PMC10684334 |
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1. Introduction | blood diseases, fatigue, liver damage, Fatigue, chronic liver damage | BLOOD DISEASES, LIVER DAMAGE, IMMUNODEFICIENCY | Academic Editor: Lalit Batra
Fatigue research focuses on the performance of athletes who require high performance. Fatigue is caused by the accumulation of lactic acid and ammonia in the blood during exercise, resulting in a negative correlation with exercise ability [High-intensity exercise also affects liver function. Exercise increases blood flow to the skeletal muscles while decreasing blood flow to the liver, which can lead to liver damage. Intense exercise releases enzymes from the liver, raising indicators related to liver damage such as aspartate aminotransferase (AST) and alanine aminotransferase (ALT); thus, continuing at such intensity for long periods of time can cause chronic liver damage [Serum immunoglobulin (Ig) is an immune status indicator. Low Ig levels indicate immunodeficiency, whereas high Ig levels may cause liver, chronic inflammatory, and blood diseases [Numerous researchers have made greater efforts to find a way to maintain athletic performance while maintaining high training intensities. Several studies have been conducted on the acute effects of fatigue substances, liver function, and immune function [With growing interest in traditional Chinese medicine tea beverages, the U.S. National Institutes of Health has defined herbal and botanical supplements containing herbs as “health supplements” [Various studies have recorded the health effects of SMS, such as a reduction in body fat, increase in exercise time, decrease in heart rate [ | PMC10328733 |
2. Materials and Methods | PMC10328733 |
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2.1. Participants | The sample size of 18 participants was calculated using G | PMC10328733 |
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2.2. Study Design | musculoskeletal disease | MUSCULOSKELETAL DISEASE, HIGH BLOOD PRESSURE, HEART DISEASE | This study was set as a randomized controlled trial to confirm the effect of SMS intake for 4 weeks. The study was double-blinded to increase the data reliability. Study participants were instructed not to exercise excessively the day before the measurements. A basic medical questionnaire was issued to assess whether the participants had high blood pressure, heart disease, or musculoskeletal disease and were receiving drug treatment, or whether there were any restrictions on participation in the study. The overall design of this study is presented in | PMC10328733 |
2.3. SMS Preparation | PMC10328733 |
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2.4. Blood Sampling | IGGT | BLOOD, LIVER | Blood samples were taken twice before and after exercise to analyze the measurement variables. All study participants were asked to fast for at least 10 hr before measurements. Between 8 and 9 AM, 10 mL of blood was collected from the forearm vein. The collected blood was placed in an ethylenediaminetetraacetic acid-treated tube to inhibit coagulation. The serum was then separated by centrifugation at 3,000 rpm for 10 min (Combi-514, Hanil, Korea).Ammonia was analyzed using the NH3L system (Roche, Switzerland), and lactic acid was measured using a Cobas Integra 800 (Roche, Switzerland) biochemical analyzer. Liver function (AST and ALT levels) was analyzed using AST-ALT reagents (Bayer, USA) and an ADVIA 1650 device (Bayer, Japan). IgA, IgG, and IgM levels were analyzed by immunoturbidity measurements using IGGT, IGA, and IGM devices (Roche Diagnostic System, Germany). After mixing each antiserum with serum and incubation at 37°C for 10 min, absorbance was measured at 340 nm (Integra 800, Roche, Switzerland), and the concentration of IgA, IgG, and IgM was determined from the concentration in the standard curve [ | PMC10328733 |
2.5. Statistical Analysis | fatigue | All data were analyzed using IBM SPSS 27.0. The data are presented as the mean and standard deviation. Two-way analysis of variance was performed with treatment (SMS and placebo) and time (before exercise and after exercise) as independent variables to investigate the effect of SMS intake on fatigue substances, liver function, and immune function during high-intensity exercise. The least-significant difference (LSD) test was used for post hoc analysis. Pearson's correlation analysis was performed using the difference values ( | PMC10328733 |
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3. Results | PMC10328733 |
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3.1. Effects of SMS Intake on Fatigue-Related Substances during High-Intensity Exercise | PMC10328733 |
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3.2. Effects of SMS Intake on Liver Function during High-Intensity Exercise | PMC10328733 |
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3.3. Effects of SMS Intake on Immune Function during High-Intensity Exercise | PMC10328733 |
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3.4. Correlation between Changes in Measurement Variables | PMC10328733 |
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4. Discussion | fatigue, upper respiratory tract infections, muscle contraction, respiratory diseases, IgA, skeletal muscle fatigue, Continuous muscle contraction | RESPIRATORY DISEASE, OXIDATIVE STRESS, UPPER RESPIRATORY TRACT INFECTIONS | We confirmed the correlation between fatigue (ammonia and lactic acid), liver function (ALT and AST), and immunity (IgA, IgG, and IgM) variables by analyzing changes between treatments (SMS or placebo control), time, and time × treatment interaction to determine whether SMS intake can protect and/or improve the negative effects of high-intensity exercise. We found a significant interaction effect among ammonia, ALT, and IgA, and a positive correlation between In a meta-analysis examining the effect of ginseng on fatigue, consumption of 1,000 mg or more per day resulted in a decrease in fatigue, although the number of included studies was small [Continuous muscle contraction due to high-intensity training causes skeletal muscle fatigue. Therefore, lactic acid transport and recovery are critical because the accumulation of high concentrations of lactic acid inhibits the release of calcium from the sarcoplasmic reticulum and interferes with muscle contraction [There is a positive correlation between the increase in blood lactate and ammonia during exercise [
ALT showed a significant time × treatment interaction in the SMS group. The significant decrease in AST compared to that before exercise is attributed to the removal of free radicals and a reduction in oxidative stress by the Ginseng is a natural ingredient often used in oriental medicine to improve fatigue and stamina. Various effects of ginsenoside, the main component of ginseng, have been reported on the central nervous system, neuroendocrine function, immune function, and cardiovascular system, depending on the dosage and method [Regular exercise can strengthen the immune system. However, strenuous physical activity can cause stress and weaken the immune system, which increases the risk of respiratory diseases in athletes who engage in high-intensity endurance exercise [A decrease in the concentration of IgA after exercise in endurance sports athletes may be an indication for an increase in the incidence of upper respiratory tract infections [SMS intake decreased ammonia levels during high-intensity exercise, decreased liver function variables (AST and ALT), and altered Ig levels. These results suggest that SMS intake during high-intensity exercise may have a positive effect on fatigue, liver function, and immunity.The results of this study should be interpreted in the context of the following limitations. First, the participants' daily lifestyle could not be controlled. Second, the number of participants was relatively small and the study period was short. Because this study was limited to male tennis players, it may be difficult to generalize the results to other populations. Therefore, future research will be based on various subjects of other sports, ages, and gender. | PMC10328733 |
Acknowledgments | The authors would like to thank the researchers for their expertise throughout the testing procedures and the players and staff of the tennis team in the Republic of Korea for their hard work and cooperation throughout the study. | PMC10328733 |
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Data Availability | The (DATA TYPE) data used to support the findings of this study are available from the corresponding author upon request. | PMC10328733 |
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Conflicts of Interest | The authors declare that they have no conflicts of interest.Study design. Twenty participants, excluding dropouts, were randomly assigned to either the SMS (Effect of The effects of Effect of Correlation of changes in fatigue-related substances, liver function variables, and immunoglobulins. All data are significantly positively correlated. (a, b) Participant characteristics.Values are presented as mean ± standard deviation. Variables were compared with independent-sample | PMC10328733 |
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Background | eating and emotional eating, eating behaviour traits | ADIPOSITY | Previous studies demonstrated a relation between takeaway outlet exposure and health outcomes. Individual characteristics, such as eating behaviour traits, could make some people more susceptible to the influence of the food environment. Few studies have investigated this topic. We aimed to investigate the moderating role of eating behaviour traits (cognitive restraint, uncontrolled eating and emotional eating) in the association between neighbourhood exposure to hot food takeaway outlets (hereafter referred to as takeaway outlets), and takeaway food consumption and adiposity. | PMC10212760 |
Methods | eating behaviour traits | We used cross-sectional data from a cohort in Cambridgeshire, UK (The Fenland study). Takeaway outlet exposure was derived using participants’ residential address and data from local authorities and divided into quarters. The Three Factor Eating questionnaire (TFEQ-R18) was used to measure eating behaviour traits. Primary outcomes were consumption of takeaway-like foods (derived from food frequency questionnaire), and body fat percentage (measured using dual-energy X-ray absorptiometry). | PMC10212760 |
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Results | Mean age of participants ( | PMC10212760 |
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Conclusion | Eating behaviour traits | Eating behaviour traits and exposure to takeaway outlets were associated with greater takeaway consumption and body fat, but evidence that individuals with certain traits are more susceptible to takeaway outlets was weak. The findings indicate that interventions at both the individual and environmental levels are needed to comprehensively address unhealthy diets. | PMC10212760 |
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Trial registry | ISRCTN72077169 | PMC10212760 |
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Subject terms | PMC10212760 |
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Introduction | obesity, eating behaviour traits | OBESITY, ADIPOSITY | The obesogenic environment has been defined as the “sum of the influences that the surroundings, opportunities or conditions of life have on promoting obesity in individuals and populations” [While the evidence base is generally inconclusive [Despite the presence of high numbers of takeaway outlets in their environment, some individuals are still able to eat well and maintain a healthy weight [Eating behaviour traits are characteristics of individuals that influence behaviour and do not tend to fluctuate on a day-to-day basis [In this study we investigated the moderating role of eating behaviour traits in the relationship between exposure to nearby takeaway outlets, individual takeaway consumption and adiposity. | PMC10212760 |
Methods | PMC10212760 |
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Study sample | Between 2005 and 2015, adults born between 1950 and 1975 were recruited to the Fenland Study from the population-based registers of general practices in Cambridgeshire, the UK [ | PMC10212760 |
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Exposure | The exposure of interest was the number of takeaway outlets within the residential neighbourhood, defined as a 1 mile radius around participants’ home address [ | PMC10212760 |
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Outcomes | adiposity | SECONDARY, ADIPOSITY | Two primary outcomes were used; consumption of energy dense “takeaway foods” which can be commonly obtained from takeaway food outlets, and adiposity, which in the present analyses were expressed as body fat percentage from dual-energy X-ray absorptiometry (DEXA) measurement. We included both takeaway-like food consumption as well as body fat percentage as outcomes as takeaway consumption is a proximal outcome of takeaway outlet exposure, and takeaway consumption has been shown to be positively associated to body weight and adiposity [Takeaway consumption was measured using data from a food frequency questionnaire. We calculated intake (g/day) of pizza, burgers, fried fish, and French fries. Together, these foods provide a marker of takeaway-like food consumption (g/day) referred to here as “takeaway consumption”. Procedures for how body fat percentage was measured are described elsewhere [As secondary outcomes, we included fat mass index (FMI) as a different expression of the DEXA data as well as BMI to allow for comparison with previous results from the same cohort [ | PMC10212760 |
Moderators | eating behaviour traits | As eating behaviour traits were introduced part way through the Fenland Study, this was only available in a sub-sample of the Fenland Study cohort ( | PMC10212760 |
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Covariates | We included covariates that were hypothesized to be associated with both takeaway outlet exposure as well as the outcomes but not on the causal pathway. Covariates captured in the Fenland Study general lifestyle questionnaire included sex, age, age at completion of full time education, occupation social class (categorized as professional, intermediate or working class [ | PMC10212760 |
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Statistical analyses | We reported sample characteristics using the mean (SD) for normally distributed continuous variables, and median (IQR) for skewed continuous variables. We reported sample characteristics for categorical variables as Figure | PMC10212760 |
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Flowchart of participant inclusion. | Flowchart of participant inclusion to the Fenland phase 1 study up to the analytical sample included in the current study.We divided exposure to takeaway outlets into quartiles for analysis for two reasons. First, previous analyses showed that the association between takeaway outlet exposure and takeaway consumption is non-linear [We investigated effect modification by adding multiplicative interaction terms (eating behaviour traits x takeaway outlet exposure quartile) to these models. We tested for evidence of interaction using the | PMC10212760 |
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Results | Mean age of participants was 51.0 (SD 7.2) years and 53.9% were female (Table Characteristics of the unimputed Fenland analytical sample ( | PMC10212760 |
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Takeaway consumption and body fat percentage according to eating behaviour traits, socio-demographic characteristics and takeaway outlet exposure | Figures | PMC10212760 |
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Beta regression coefficient of the association between takeaway outlet exposure and takeaway consumption stratified by eating behaviour traits. | eating behaviour traits | REGRESSION | Beta regression coefficient and 95% coefficient interval in the association between takeaway outlet exposure (taking Q1 as the reference group) and takeaway consumption stratified by eating behaviour traits. Asterisk indicates a statistically significant interaction by eating behaviour trait in the association between takeaway outlet exposure and takeaway consumption. | PMC10212760 |
Beta regression coefficient of the association between takeaway outlet exposure and body fat percentage stratified by eating behaviour traits. | eating behaviour traits | REGRESSION | Beta regression coefficient and 95% coefficient interval in the association between takeaway outlet exposure (taking Q1 as the reference group) and body fat percentage stratified by eating behaviour traits. Asterisk indicates a statistically significant interaction by eating behaviour trait in the association between takeaway outlet exposure and body fat percentage.To gain a better understanding of the moderating role of eating behaviour traits, Figs. | PMC10212760 |
Mean takeaway consumption per quartile of takeaway outlet exposure stratified by cognitive restraint. | Mean and 95% confidence interval takeaway consumption per quartile of takeaway outlet exposure in the Fenland Study ( | PMC10212760 |
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Mean body fat percentage per quartile of takeaway outlet exposure stratified by emotional eating. | Mean and 95% confidence interval body fat percentage per quartile of takeaway outlet exposure in the Fenland Study (The results in Fig. | PMC10212760 |
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Discussion | obesity, muscle mass, Eating behaviour traits, eating and cognitive restraint, adiposity, eating | OBESITY, ADIPOSITY | In a sample of almost 5000 UK adults, we found that takeaway outlet exposure as well as emotional eating and uncontrolled eating were positively associated to both takeaway consumption and body fat percentage. We also found that cognitive restraint was negatively associated with takeaway consumption, but positively associated with body fat percentage. Eating behaviour traits partly moderated the association between takeaway outlet exposure and takeaway consumption and body fat percentage. Specifically, uncontrolled eating did not moderate the association between takeaway outlet exposure, and takeaway consumption and body fat percentage. Cognitive restraint moderated the association between takeaway outlet exposure and takeaway consumption, and emotional eating moderated the association between takeaway outlet exposure and body fat percentage. Namely, the association between takeaway outlet exposure and takeaway consumption was somewhat stronger for individuals with high cognitive restraint scores compared to lower cognitive restraint scores. Furthermore, the association between takeaway outlet exposure and body fat percentage was somewhat stronger for individuals with low emotional eating scores compared to higher emotional eating scores. However, these effects were small in all cases.While the evidence base with regards to the association between exposure to food outlets in residential neighbourhoods and dietary behaviours is generally mixed [We found some evidence of effect modification by cognitive restraint and emotional eating, but not uncontrolled eating. Furthermore, the moderating role of emotional eating and cognitive restraint on the association between takeaway outlet exposure, and takeaway consumption and adiposity was relatively small. As the evidence for interaction was not consistent across potential moderators and outcomes, and given the number of tests performed, it is possible that our findings are based on chance. The small moderating role of cognitive restraint and emotional eating is, however, not surprising as takeaway outlets are responsible for only a small amount of the variance in adiposity. Also, the direction of the effect modification is not surprising, which we explain in the following paragraphs.Cognitive restraint was negatively associated with reported takeaway consumption, but positively associated with body fat percentage. Given the positive association between takeaway consumption and body weight [In the current analysis, emotional eating was positively associated with both takeaway consumption and body fat percentage. Contrary to the aforementioned study [The current study results suggest that those exposed to the most takeaway outlets are at an increased risk of adiposity than those exposed to the least takeaway outlets. Thus, intervening on eating behaviour traits alone to improve health outcomes will not remove the negative influence the current obesogenic environment has on these health outcomes. The reverse is also true; intervening only on the food environment will not remove all individual differences in dietary behaviours and adiposity. As such, there is a need to implement integrated strategies addressing both individual and environmental influences on dietary behaviours. Multiple interventions at different levels of influence need to be implemented to reduce unhealthy dietary behaviours and obesity levels, including downstream approaches targeting individuals most at risk (e.g. mindfulness meditation for high emotional eaters [Our study has several strengths including having extensively measured diet, body weight, adiposity and the food environment. In particular, we used an objective imaging method to measure adiposity instead of BMI which is, among other things, unable to differentiate between fat mass and muscle mass [Besides longitudinal studies, further research is needed in different populations to confirm the current study results. This research may use other, more reliable or complementary, eating behaviour trait measurements such as the new version of the TFEQ (TFEQ-R21 [ | PMC10212760 |
Conclusion | obesity | OBESITY, ADIPOSITY | Individual differences in eating behaviour traits and exposure to takeaway outlets were both associated with takeaway consumption and adiposity. The evidence that individuals with certain eating behaviour traits are more susceptible to takeaway outlets was weak; there was no evidence that the association between takeaway outlet exposure and takeaway consumption or body fat varied by uncontrolled eating. While the magnitude of other effects were small, we found that the positive association between takeaway outlet exposure and body fat percentage was strongest for low emotional eaters, and the positive association between takeaway outlet exposure and takeaway consumption was strongest for those with high cognitive restraint scores. Our findings indicate that it is important to implement integrated strategies addressing both individual and environmental influences of dietary behaviours to tackle the current obesity epidemic. | PMC10212760 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41366-023-01290-9. | PMC10212760 |
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Acknowledgements | We would like to thank the Fenland participants for participating in the study, as well as the Fenland Study Coordination, Field Epidemiology and Data Management teams for supplying the data. We also thank David Collins for his statistical advice and Stephen Sharp for his help interpreting and presenting the results. | PMC10212760 |
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Author contributions | TB | JA, TB and AA conceived the idea for the work. The analysis plan was designed by JCH, TB and JA. TB led the takeaway outlet data collection from local councils. JCH led the data analysis, in consultation with TB, AA, SB, PM and JA. Principal investigators of the Fenland study who were responsible for its overall design, management and supervision of data collection are SB, NGF, SG and NJW. JCH drafted the manuscript and JCH, TB and JA interpreted the results. All authors reviewed and edited the manuscript. | PMC10212760 |
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Funding | TB | The Fenland Study is funded by the MRC and the study PIs (NJW, SB, NGF and SG) acknowledge this support (grant numbers MC_UU_00006/1, MC_UU_00006/3, MC_UU_00006/6). JCH, JA and TB are currently supported by the Medical Research Council [Unit Programme number MC_UU_00006/7]. PM received support from the Health Equity Research Center at Washington State University. SB, NGF and NJW acknowledge support from the National Institute of Health Research (NIHR) Cambridge Biomedical Research Centre (BRC) Nutrition, Diet, and Lifestyle Research Theme (IS-BRC-1215-20014). NGF is an NIHR Senior Investigator. The University of Cambridge has received salary support in respect of SG from the NHS in the East of England through the Clinical Academic Reserve. The funders played no role in the design of the study, the collection, analysis, and interpretation of data, or the writing of the manuscript. For the purpose of Open Access, the authors have applied a Creative Commons Attribution (CC BY) licence to any Author Accepted Manuscript version arising. | PMC10212760 |
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Data availability | While the Fenland Study ( | PMC10212760 |
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Competing interests | The authors declare no competing interests. | PMC10212760 |
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Ethics approval and consent to participate | The study complies with the Declaration of Helsinki and was approved by the Health Research Authority National Research Ethics Service Committee East of England-Cambridge Central. Informed consent was obtained from all the participants before starting the study. | PMC10212760 |
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References | PMC10212760 |
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Background: | anxiety | This research addresses inadequate understanding of interventional prenatal diagnosis, preoperative anxiety psychological problems in pregnant women undergoing interventional prenatal diagnosis, proposing a health education mode combined AIDET standard communication and King's theory of goal attainment approach to potentially improve health education outcomes, anxiety psychological problems, and patient satisfaction. | PMC10695492 |
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Methods: | anxiety | DISEASE | A convenient sampling method was used to select a total of 300 pregnant women who were ready to undergo interventional prenatal diagnosis. They were randomly divided into a implementation group and a control group, with 150 pregnant women in each group. The control group used the communication mode of the traditional process of nurse–patient communication. The implementation group used the AIDET standard communication health education model under the King theory of goal attainment in the process of nurse–patient communication and the interventional prenatal diagnosis health education content questionnaire, the pregnant women’s satisfaction questionnaire, state anxiety scale, and disease uncertainty scale were used for evaluation. | PMC10695492 |
Results: | anxiety | DISEASE | The results of the interventional prenatal diagnosis health education questionnaire, the results of pregnant women’s anxiety, the results of pregnant women’s disease uncertainty, the results of pregnant women’s satisfaction, the implementation group all were better than the control group ( | PMC10695492 |
Conclusion: | anxiety | DISEASE | Using the AIDET standard communication health education model under the King theory of goal attainment in nurse–patient communication is conducive to the rapid establishment of a harmonious and trusting nurse–patient relationship between pregnant women and nurses, helping pregnant women and nurses jointly promote the establishment and implementation of health education goals, helping to improve pregnant women’s acceptance of information related to interventional prenatal diagnosis, health education and the procedure of walking on the day of surgery. It helps enhance the effectiveness of health education and satisfaction, reducing pregnant women’s uncertainty about the disease, their unfamiliarity with the surgery environment and surgery procedure, and their preoperative anxiety. | PMC10695492 |
1. Introduction | death, congenital disability, Birth defect, verbal communication and nonverbal communication, disability | MISCARRIAGE | Birth defect refers to the abnormalities on the structural and functional metabolism of human embryos or fetuses that exist at birth, which mainly causes early miscarriage, stillbirth, perinatal death, infant death, and congenital disability, and can lead to long-term defects on children, furthermore, disability and illness seriously affect the fetuses qualities.Acknowledge (A), Introduction (I), Duration (D), Explanation (E), and Thank (T) (AIDET) communication mode, including AIDET 5 procedures, is a standardized communication mode developed by the Studer Group team. While emphasizing the importance of verbal communication and nonverbal communication, there are 5 aspects including AIDET, that promotes the procedures and standard languages of effective and in-depth communication between nurses and patient shown as Figure AIDET standard communication mode. It briefly explains the 5 steps of the AIDET standardized communication model.The King Theory of Goal Attainment shown as Figure The nurse–patient interaction process of The King Theory of Goal Attainment. It briefly explains the actions, reactions and interactions between patient and nurse under The King Theory of Goal Attainment.After reviewing a large number of relevant literature, there is no research and report about the integration of The King Theory of Goal Attainment and AIDET communication mode, neither no implementation about outpatient communication and the outpatient health education of prenatal diagnosis care. This study aims to construct the AIDET standard communication health education mode based on The King Theory of Goal Attainment (the framework shown as Figure The AIDET standard communication mode under The King Theory of Goal Attainment. It briefly explains how AIDET standard communication mode and The King Theory of Goal Attainment can be interactively integrated and applied to nurse-patient communication. | PMC10695492 |
2. Objects and Methods | PMC10695492 |
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2.1. Research object | mental disorders or cognitive disorders, hearing or vision impairment | DISEASES | Convenient sampling was used to select a total of 300 pregnant women who planned to undergo interventional prenatal diagnosis at the prenatal diagnosis center of a tertiary first-class hospital in Sichuan Province from the April 2020 to the January 2021, among which 150 pregnant women were randomly selected as control group who planned to undergo interventional prenatal diagnosis from the April 2020 to the August 2020 by the random number method. The rest 150 people who were about to take interventional prenatal diagnosis from the September 2020 to the January 2021 served as experimental group.Inclusion criteria: ① Meeting the guidelines for prenatal diagnosis; ② the first time of undergoing interventional prenatal diagnosis; ③ volunteering in the study and signing the informed consent form; ④ people with self-behavior ability. Exclusion criteria: ① people with mental disorders or cognitive disorders related diseases; ② people with hearing or vision impairment; ③ unable to communicate normally. Rejection criteria: ① withdrawing from the research during the study period; ② people who have poor compliance and fail to complete the research in accordance by the intervention plan; ③ providing invalid information. | PMC10695492 |
2.2. Research methods | PMC10695492 |
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2.2.1. Control group. | The control group adopted the traditional communication mode: explaining the purpose and function of interventional prenatal diagnosis, indications, contraindications, limitations, risks, etc. to pregnant women as well as signing the informed consent, while making an appointment for interventional prenata and introducing the precautions before and after interventional prenatal diagnosis. | PMC10695492 |
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2.2.2. Implementation group. | The implementation group adopted the AIDET standard communication health education mode under The King Theory of Goal Attainment on the nurse–patient communication process. The specific implementation methods are conducted below: | PMC10695492 |
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2.2.2.1. Preparation stage. | PMC10695492 |
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2.2.2.1.1. Establish an implementation team. | The implementation team consists of the deputy director of the nursing department, head nurses of the department, charge nurses, attending physicians, clinical nurses, health managers, and reproductive health consultants. Among them, there are 12 people including 5 senior titles, 3 intermediate titles, and 4 junior titles in total. | PMC10695492 |
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2.2.2.1.2. Team member training. | After the team were established, the team members will be trained first. The training content includes: AIDET communication mode and The King Theory of Goal Attainment’s related concepts, frameworks and implementation examples (previous related research) and other related content. After the training, the team members will be assessed. After the team members passing the assessment, they will use the AIDET standard communication health education mode under The King Theory of Goal Attainment on the process of nurse-patient communication and implementation of health education. | PMC10695492 |
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2.2.2.2. Implementation phase. | The AIDET communication health education mode under the King Theory of Goal Attainment are shown in Table The framework of AIDET communication mode under the King Theory of Goal Attainment. | PMC10695492 |
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2.2.3. Research tools. | PMC10695492 |
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2.2.3.1. General information questionnaire. | bad pregnancy | Self-made general information questionnaire that includes the pregnant woman’s name, age, gestational age, educational level, presence or absence of children, marital status, reproductive history, the history of bad pregnancy, family monthly income, residence, etc. | PMC10695492 |
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2.2.3.2. Questionnaire on health education content of interventional prenatal diagnosis. | The self-made content questionnaire of interventional prenatal diagnosis health education is mainly based on the preoperative and postoperative precautions of interventional prenatal diagnosis as well as the procedures and walking routes on the day of interventional prenatal diagnosis. It consists of 3 levels and 12 contents: preoperative precautions for interventional prenatal diagnosis (5 items), preoperative precautions for interventional prenatal diagnosis (5 items), and procedure and walking route on the day of interventional prenatal diagnosis (2 items). In order to understand the effectiveness of health education methods and the acceptance of health education content, in this study, the reliability of the questionnaire Cronbach α coefficient is 0.905, which is indicating that the questionnaire has good reliability. | PMC10695492 |
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2.2.3.3. Questionnaire on satisfaction of pregnant women. | Researchers have consulted a large number of literature and combined with the framework and the content of the AIDET communication health education mode under the King Theory of Goal Attainment while combining with the characteristics of the prenatal diagnosis center to summarize and design a pregnant woman satisfaction questionnaire. | PMC10695492 |
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2.2.3.4. State Anxiety Scale (S-AI). | Anxiety | The State-Trait Anxiety Inventory State (S-AI) | PMC10695492 |
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2.2.3.5. Medical Uncertainty Inventory Scale (MUIS). | Using domestic scholars such as Xu Shulian | PMC10695492 |
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2.2.4. Statistical methods. | SPSS25.0 software is used to establish the database for data entry and statistical analysis. The counting data is described by frequency and composition ratio and the measurement data is described by X ± S. Two-paired sample | PMC10695492 |
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3. Results | PMC10695492 |
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3.3. Comparison of results of pregnant women’s anxiety state and illness uncertainty | anxiety | All the results of experimental group were higher than the control group and the difference was statistically significant (Comparison of the results of the 2 groups of pregnant women’s anxiety state and illness uncertainty. | PMC10695492 |
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3.4. Comparison of pregnant women’s satisfaction results | All the results of experimental group were higher than the control group and the difference was statistically significant (Comparison of the satisfaction results of the 2 groups of pregnant women. | PMC10695492 |
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4. Discussion | PMC10695492 |
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4.1. The AIDET standard communication health education mode under the King Theory of Goal Attainment improves the goal and effectiveness of health education | The results show that, from Table Secondly, in the process link, under the guidance of the King Theory of Goal Attainment, the process of interactive assessment, and the nurse-patient joint development of the target plan, nurses and pregnant women deepen their trust through the processes of perception, judgment, action, reaction and interaction. To the purpose of trusting each other, pregnant women can follow the nurse’s follow-up explanation and interventional prenatal diagnosis purpose, function, indications, contraindications, limitations, risks and other related information, interventional prenatal diagnosis before surgery, postoperative precautions, etc. It is accelerated that the content of health education is more valued and trusted. The nurses deepened their understanding and memory of the content through the use of common and easy-to-understand language. In addition, in the communication between pregnant women and nurses, nurses can promptly correct the problems of the pregnant women’s knowledge about interventional prenatal diagnosis, which improves the pregnant women’s awareness of interventional prenatal diagnosis. Finally, in the explanation and Acknowledgments link, the nurses evaluated the effects of the health education goals set by the pregnant women once again. If the pregnant women did not fully grasp the content of the health education goals set, the nurses would reevaluate the content that they did not master. Targeted explanations need to be multiply taught until the health education goals are fully met. Thereby, it enhanced the goals and effectiveness of health education and made health education truly change the cognition of pregnant women. It is helpful to allow pregnant women to establish a correct understanding of interventional prenatal diagnosis and to promote the purpose of pregnant women performing behaviors conducive to postoperative recovery.Similarly, the research results once again proved that the nurses and the pregnant women have strengthened mutual trust while forming a good and harmonious nurse-patient communication relationship and cooperated with each other by implementing the AIDET standard communication health education mode under the King Theory of Goal Attainment. The improvement of concentration is promoted as well as the importance and acceptance of pregnant women for information related to interventional understanding of memory. | PMC10695492 |
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4.2 . The AIDET standard communication health education mode under the King Theory of Goal Attainment can help reduce the uncertainty about the disease and improve the preoperative anxiety of pregnant women | anxiety, traumatic | Pregnant women could feel intense uncertainty and anxiety about the interventional prenatal diagnosis due to that interventional prenatal diagnosis is a kind of invasive and traumatic operation, which the pregnant women receive insufficient health education and the channels to obtain relevant information are limited and incomplete. As shown in Table Besides, under the guidance of the King Theory of Goal Attainment, in accordance with the current individual situation of pregnant women and the individualized health education goals jointly formulated by nurses and pregnant women, pregnant women are actively invited to participate in nursing decision-making and the past passive health education methods of pregnant women are converted into active participation in the interaction with nurses through the processes of perception, judgment, action, reaction and interaction, and finally communication with each other to promote the achievement of the goal, | PMC10695492 |
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4.3. The AIDET standard communication health education mode under The King Theory of Goal Attainment helps to improve pregnant women’s satisfaction with medical care | As shown in Table | PMC10695492 |
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5. Limitations | pain | COMPLICATIONS | On the one hand, the research objects of this study are mainly selected from the prenatal diagnosis center of a tertiary hospital in Chengdu, Sichuan Province. The results could be affected by the sample size, economic development level, and comprehensive population quality. Therefore, in future research, researchers can expand the sample size and include pregnant women from the different prenatal diagnosis centers of different provinces and cities as the research objects in the study so as to avoid the impact caused by limitations in sample size, region, and population quality. In addition, there are certain obstacles in data collection, ling-term intervention and follow-up visit due to the various of samples who are mostly from multiple cities in Sichuan and a few form other provinces. Therefore, it has caused certain difficulties in carrying out long-term longitudinal research. Accordingly, in the future research, we can consider selecting local pregnant women and applying the AIDET standard communication health education mode under the King Theory of Goal Attainment, which the study process is: launching an appointment for interventional prenatal diagnosis from obstetric clinic/genetic consultation—clinic-prenatal diagnosis center-intervention—prenatal diagnosis surgery—a longitudinal study of follow-up after interventional prenatal diagnosis, in order to carry out a longer-term effect evaluation (pain perception recovery, activity recovery, complications, etc). | PMC10695492 |
Acknowledgments | The authors thank all the participants and institutions that participated in this study and gave their contribution. Thanks to Mrs. Xue Du, Mrs. Yujia Guan, Professor Wentao Peng, and Associate Professor Wanying Luo for supporting, directing, and organizing all the completed process of research. | PMC10695492 |
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Abbreviation: | Anxiety, W. | WEST | Acknowledge (A), Introduction (I), Duration (D), Explanation (E), and Thank (T)Medical Uncertainty Inventory ScaleState Anxiety InventoryThis work was supported by Quality of life care research fund of Chinese Association For Life Care (project number: HL20210144); Sichuan Nursing Research Project (project number: H22052); 2023 Chengdu Medical Research Project (project number: 2023256).Ethical approval was taken from the Ethics Committee of West China Second University Hospital, Sichuan University. Informed consent was obtained from all the subjects. All methods carried out were in accordance with West China Second University Hospital, Sichuan University guidelines and regulations and in accordance with Declarations of Helsinki.The authors have no conflicts of interest to disclose.The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.How to cite this article: Yang H, Luo W, Du X, Guan Y, Peng W. The implementation and effect evaluation of AIDET standard communication health education mode under the King theory of goal attainment: A randomized control study. Medicine 2023;102:48(e36083). | PMC10695492 |
References | PMC10695492 |
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Introduction | type 2 diabetes, T2DM | TYPE 2 DIABETES | Edited by: Davide Tinti, University of Turin, ItalyReviewed by: Tianshu Zeng, Huazhong University of Science and Technology, China; Bin Wu, First Affiliated Hospital of Kunming Medical University, ChinaWe aimed to evaluated the effect of premixed insulin (Ins), premixed insulin combined with metformin (Ins+Met) or mulberry twig alkaloids(Ins+SZ-A) on blood glucose fluctuations in patients with type 2 diabetes (T2DM) using continuous glucose monitors (CGM). | PMC10653384 |
Methods | T2DM, fasting blood glucose, postprandial blood glucose, glucose excursions | Thirty patients with T2DM and poor blood glucose control using drugs were evaluated for eligibility during the screening period. Subsequently, their original hypoglycemic drugs were discontinued during the lead-in period, and after receiving Ins intensive treatment for 2 weeks, they were randomly assigned to receive either Ins, Ins+Met, or Ins+SZ-A treatment for the following 12 weeks. The main efficacy endpoint comprised changes in their CGM indicators changes (mean blood glucose level [MBG], standard deviation of blood glucose [SDBG], mean amplitude of glycemic excursions [MAGE], postprandial glucose excursions [PPGE], the largest amplitude of glycemic excursions [LAGE], mean of daily difference [MODD], time in range between 3.9–10.0 mmol/L [TIR] and area under the curve for each meal [AUCpp]) during the screening, lead-in, and after 12-week treatment period. Changes in glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG), 1-h postprandial blood glucose (1h-PBG), 2-h postprandial blood glucose (2h-PBG), fasting blood lipids and postprandial blood lipids were also measured at baseline and after 12 weeks of treatment | PMC10653384 |
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Results | The CGM indicators of the three groups during the lead-in period all showed significant improvements compared to the screening period (P<0.05). Compared with those in the lead-in period, all of the CGM indicators improved in the the Ins+Met and Ins+SZ-A groups after 12 weeks of treatment (P<0.05), except for MODD. After 12-week treatment, compared with the Ins group, Ins+Met and Ins+SZ-A groups showed improved MBG, SDBG, TIR, breakfast AUCpp,lunch AUCpp, HbA1c, FBG, 1h-PBG, fasting blood lipid and postprandial blood lipid indicators (P<0.05). Further, the LAGE, PPGE, MAGE, dinner AUCpp and 2h-PBG levels of the Ins+SZ-A group were significantly lower than those of the Ins+Met and Ins groups (P<0.05). | PMC10653384 |
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Conclusion | blood glucose fluctuations | Our findings highlight the efficacy of combination therapy (Ins+SZ-A or Ins+Met) in improving blood glucose fluctuations, as well as blood glucose and lipid levels. Ins+SZ-A reduces postprandial blood glucose fluctuations more than Ins+Met and Ins groups. | PMC10653384 |
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Trial registration number | ISRCTN20835488. | PMC10653384 |
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Introduction | hypoglycemic drug, blood glucose, hypoglycemic, type 2 diabetes, T2DM | TYPE 2 DIABETES | Mulberry twig alkaloids (SZ-A) represent the first original natural hypoglycemic drug to be discovered in China. They are capable of effectively inhibiting α-glycosidase and thus exerting beneficial hypoglycemic effects. One multi-center, randomized, double-blinded, and parallel controlled trial showed that after 24 weeks of treatment with SZ-A, patient levels of glycosylated hemoglobin (HbA1c) decreased by 0.93% from baseline, and their rate of achieving the HbA1c target (HbA1c<7%) was 47.7%—which was equivalent to that of treatment with acarbose for reducing postprandial blood glucose (When oral hypoglycemic drugs fail to control blood glucose in patients with type 2 diabetes (T2DM), these patients typically begin using insulin (Metformin(Met) is the first-line drug for the treatment of T2DM and plays an anti-hyperglycemic role mainly by inhibiting liver glucose through AMPK-dependent or -independent pathways (Continuous glucose monitors (CGM) can measure glucose concentrations in the subcutaneous interstitial fluid 288 times per day using multiple glucose sensors, allowing them to provide continuous, complete,and reliable glucose measurements with good compliance. To our knowledge, no studies have investigated the effects of SZ-A on blood glucose fluctuations.Therefore, in this study, CGMs were used to comprehensively evaluate blood glucose changes in patients with T2DM who were treated with premixed insulin combined with SZ-A or Met, compared to other treated with premixed insulin alone. We also considered blood lipid parameters, to provide a basis for exploring the hypoglycemic characteristics of SZ-A and determining the most suitable patients population for this treatment. | PMC10653384 |
Materials and methods | PMC10653384 |
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Study design and participants | chronic gastrointestinal dysfunction, allergic, flatulence, unstable angina pectoris, neurological disorders, alcoholism, hernia, Cushing’s syndrome, ’s syndrome, hypoglycemic, substance addictions, acromegaly, T2DM, diabetes | INTESTINAL ULCERS, UNSTABLE ANGINA PECTORIS, INTESTINAL OBSTRUCTION, NEUROLOGICAL DISORDERS, DISORDERS, TYPE 1 DIABETES MELLITUS, HYPERTHYROIDISM, ENDOCRINE DISEASES, HEART DISEASES, DIABETIC COMPLICATIONS, ACROMEGALY, DISEASES, SECONDARY DIABETES MELLITUS, DIABETES | This was a 12-week open-label, randomized, parallel-controlled, clinical trial. We enrolled patients with T2DM who had poorly controlled blood glucose levels when using oral hypoglycemic agents, and had been hospitalized in the Department of Endocrinology and Metabolism of the First Affiliated Hospital of Harbin Medical University between June 2022 and March 2023.The inclusion criteria were patients who: 1) were aged 18–70 years old, regardless of sex; 2) had body mass index(BMI) between 19 kg/mThe exclusion criteria were patients who: 1) were allergic or intolerant to α-glucosidase inhibitors, or for whom these drugs had been proven to be ineffective; 2) had severe diabetic complications; 3) had secondary diabetes mellitus, specific types of diabetes, and type 1 diabetes mellitus; 4) had chronic gastrointestinal dysfunction, obvious digestive and absorption disorders, as well as other endocrine diseases, such as hyperthyroidism, Cushing’s syndrome,or acromegaly, etc; 5) had diseases that could be worsened by flatulence (such as Roeheld’s syndrome, severe hernia, intestinal obstruction, following gastrointestinal surgery and intestinal ulcers); 6) had unstable angina pectoris within 6 months prior to the study, had serious heart diseases, or were likely to die during the treatment and follow-up period; 7) had mental and neurological disorders who could not clearly express themselves; 8) were suffering from alcoholism or other substance addictions; 9) were women of childbearing age who were pregnant, lactating, had a positive pregnancy test (urine or blood HCG), intended to become pregnant over the study and follow-up period, or could not take effective contraceptive measures during the study and follow-up period (including measures such as sterilization, intrauterine devices, and oral contraceptives); 10) had participated in clinical trials of other drugs or medical devices in the three months preceding the study’s start date.This study was approved by the Ethics Review Committee of the First Affiliated Hospital of Harbin Medical University (Harbin, China). All participants provided written informed consent prior to registration. All experiments were conducted in accordance with the principles of the Declaration of Helsinki. | PMC10653384 |
Randomization and treatment | fasting blood glucose, hypoglycemic, diabetes | HYPERGLYCEMIA, DIABETES | During the screening period patients used their regular hypoglycemic drugs and evaluations for eligibility to select study subjects were conducted based on the inclusion and exclusion criteria. During the lead-in period, the patients’ regular hypoglycemic drugs were discontinued and a premixed insulin-intensive treatment was administered for 2 weeks to quickly correct hyperglycemia. After 2 weeks of this intensive treatment, the patients were randomly divided into premixed insulin (Ins), premixed insulin plus SZ-A (Ins+SZ-A) and premixed insulin plus Met (Ins+MET) groups for the following 12 weeks (Flowchart of the study.The goal in terms of fasting blood glucose control for this study was 4.4–7.0 mmol/L. The initial premixed insulin dose was 0.4–0.5 IU/kg, after which, it was adjusted as needed, according to plasma glucose values obtained through self-monitoring. The initial dose of SZ-A (Beijing Guokaihua Intellectual Property Agency Co., LTD, Beijing, China) was 50mg, administered three times per day, at mealtimes. After four weeks, this dose was increased to 100mg three times per day at mealtimes. The Met dose (Sino-American Shanghai Squibb Pharmaceuticals Co., Ltd, Shanghai, China) was 500mg three times per day at mealtimes, throughout the entire observation period. The first 6 weeks of the treatment phase comprised the insulin dose titration period. Patients were required to self-monitor their blood glucose levels, and a trained doctor adjust their insulin doses based on the results obtained. The following 6 weeks comprised the steady dose period. The patients received diabetes education during this phase, in order to promote reasonable dietary control and proper exercise over the rest of the study period. | PMC10653384 |
Anthropometric indicators | TG, hypoglycemic, diabetes | ADVERSE EVENTS, HYPOGLYCEMIA, INSULIN RESISTANCE, BLOOD, DIABETES | The general patients information collected included sex, age,diabetes history, height, weight, BMI, waist circumference, hip circumference, and insulin dose. Fasting blood glucose (FBG), HbA1C, C-peptide, cholesterol (CHOL), triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) levels were measured during the screening period and after 12 weeks of treatment. An automatic biochemical analyzer assessed hypoglycemia, adverse events, alanine aminotransferase (ALT), aspartate transaminase (AST), creatinine (Cr), and uric acid (UA).The insulin resistance index was assessed for each patients using modified homeostasis model, and expressed as [HOMA-IR(CP)] = 1.5 + FPG (mmol/L) × fasting C-peptide (pmol/L)/2,800 (The oral glucose tolerance tests (OGTT) experiment was conducted during the lead-in period, where participants received 75 g of orally-administered glucose in the morning after fasting for 10 to 12h. Blood samples were collected at 0, 60, and 120 min afterward, to measure plasma glucose concentrations.After 12 weeks of treatment, the participants fasted overnight, were treated with their corresponding hypoglycemic drugs (Ins, Ins+Met, or Ins+SZ-A), and consumed 70 g of instant noodles (500 kcal, 70 g of carbohydrates) within 15 min ( | PMC10653384 |
CGM parameters | mean blood glucose | Subcutaneous interstitial glucose monitoring was conducted using a CGM system (Medtronic, Inc,Minnesota,USA) during the screening, lead-in, and after 12-week treatment period, for three consecutive days. The study parameters included mean blood glucose level (MBG), standard deviation of blood glucose (SDBG), mean amplitude of glycemic excursions (MAGE), postprandial glucose excursions (PPGE), largest amplitude of glycemic excursions (LAGE), mean of daily difference (MODD), and time-in-range between 3.9 and 10.0 mmol/L (TIR). The area under the curve (AUCpp) was calculated within 4 h of the start of each meal. | PMC10653384 |