Safety and Efficacy of Roux-en-Y Gastric Bypass to Treat Type 2 Diabetes Mellitus in Non-severely Obese Patients DiaSurg 2 trial - surgical vs. medical treatment of insulin-dependent type 2 diabetes mellitus in patients with a body mass index between 26 and 35 kg/m2: study protocol of a randomized controlled multicenter trial - DRKS00004550 Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial. Roux-en-Y gastric bypass vs sleeve gastrectomy for obese patients with type 2 diabetes: a randomised trial Effect of laparoscopic Roux-en-Y gastric bypass surgery on type 2 diabetes mellitus with hypertension: a randomized controlled trial. Sleeve gastrectomy versus Roux-en-Y gastric bypass for type 2 diabetes and morbid obesity: double-blind randomised clinical trial protocol Sleeve gastrectomy and Roux-en-Y gastric bypass are equally effective in correcting insulin resistance. Laparoscopic Roux-en-Y Gastric Bypass for the Treatment of Type II Diabetes Mellitus in Chinese Patients with Body Mass Index of 25–35 Gastric bypass significantly improves quality of life in morbidly obese patients with type 2 diabetes Long-term effects of laparoscopic sleeve gastrectomy versus roux-en-Y gastric bypass for the treatment of Chinese type 2 diabetes mellitus patients with body mass index 28-35 kg/m2 Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial. Remission of type 2 diabetes after Roux-en-Y gastric bypass or sleeve gastrectomy is associated with a distinct glycemic profile. Microvascular Outcomes in Patients With Diabetes After Bariatric Surgery Versus Usual Care Superior weight loss and lower HbA1c 3 years after duodenal switch compared with Roux-en-Y gastric bypass--a randomized controlled trial. Roux-en-Y gastric bypass surgery or lifestyle with intensive medical management in patients with type 2 diabetes: feasibility and 1-year results of a randomized clinical trial. Clinical trial demonstrates exercise following bariatric surgery improves insulin sensitivity. BariSurg trial: Sleeve gastrectomy versus Roux-en-Y gastric bypass in obese patients with BMI 35–60 kg/m2 – a multi-centre randomized patient and observer blind non-inferiority trial
The efficacy of Roux-en-Y gastric bypass ( RYGB ) to control  type 2 diabetes mellitus ( T2DM )  has been demonstrated in morbidly obese patients . Surgical procedures primarily focused on T2DM control in patients with body mass index ( BMI ) < 35 kg/m2 have shown to effectively induce remission of T2DM . However , only few reports have evaluated the safety and efficacy of RYGB in this group of patients . The aim of this study is to assess the safety and efficacy of RYGB in TD2 M patients with BMI < 35 kg/m2 . All T2DM patients with BMI < 35 kg/m2 and at least 12 months of follow-up who underwent laparoscopic RYGB were included . Safety of the procedure was evaluated according to mortality , need of reoperation/conversion , and complication rates . Metabolic parameters were evaluated at baseline and 6 , 12 , and 24 months after surgery . Thirty patients were included . Seventeen ( 56.6 % ) were women . Age , BMI , and duration of diabetes were 48 ± 9 years , 33.7 ± 1.2 kg/m2 , 4 ± 2.9 years , respectively . No mortality was observed . No conversion/reoperation was needed . Average length of stay was 3.2 ± 0.9 days . Early and late postoperative complications were observed in five ( 16.6 % ) and five ( 16.6 % ) patients , respectively . Twelve months after surgery , remission was observed in 25 of 30 patients ( 83.3 % ) . After 2 years , remission was achieved in 13 of 20 patients ( 65 % ) , and hemoglobin A1c decreased from 8.1 ± 1.8 % to 5.9 ± 1.1 % and homeostasis model assessment of insulin resistance from 5.7 ± 3.2 to 1.9 ± 0.8 after 12 months . RYGB is a safe and effective procedure to induce T2DM remission in otherwise not eligible patients for bariatric surgery . Evidence from prospect i ve studies is needed to vali date this approach Background Type 2 diabetes mellitus ( T2DM ) is a disease with high prevalence , associated with severe co-morbidities as well as being a huge burden on public health . It is known that glycemic control decreases long-term morbidity and mortality . The current st and ard therapy for T2DM is medical treatment . Several r and omized controlled trials ( RCTs ) performed in obese patients showed remission of T2DM after bariatric surgery . Recent RCTs have shown bariatric procedures to produce a similar effect in non-morbidly and non-severely obese , insulin-dependent T2DM patients suggesting procedures currently used in bariatric surgery as new therapeutical approach in patients with T2DM . This study aims at investigating whether Roux-en-Y gastric bypass ( RYGB ) is an efficient treatment for non-severely obese T2DM patients in terms of preventing long-term complications and mortality . Methods The DiaSurg 2 trial is a multicenter , open r and omized controlled trial comparing RYGB including st and ardized medical treatment if needed to exclusive st and ardized medical treatment of T2DM ( control group ) . The primary endpoint is a composite time-to-event endpoint ( cardiovascular death , myocardial infa rct ion , coronary bypass , percutaneous coronary intervention , non-fatal stroke , amputation , surgery for peripheral atherosclerotic artery disease ) , with a follow-up period of 8 years . Insulin-dependent T2DM patients aged between 30 and 65 years will be included and r and omly assigned to one of the two groups . The experimental group will receive RYGB and , if needed , st and ardized medical care , whereas the control group will receive exclusive st and ardized medical care , both according to the national treatment guidelines for T2DM . Statistical analysis is based on Cox proportional hazards regression for the intention-to-treat population . Assuming a loss to follow-up rate of 20 % , 200 patients will be r and omly allocated to the comparison groups . A total sample size of n = 400 is sufficient to ensure 80 % power in a two-tailed significance test at alpha = 5 % . Discussion The DiaSurg2 trial will yield long-term data ( 8 years ) on diabetes-associated morbidity and mortality in patients with insulin-dependent T2DM receiving either RYGB or st and ardized medical care . Trial registration The trial protocol has been registered in the German Clinical Trials Register DRKS00004550 IMPORTANCE Many questions remain unanswered about the role of bariatric surgery for people with type 2 diabetes mellitus ( T2DM ) . OBJECTIVE To determine feasibility of a r and omized clinical trial ( RCT ) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating T2DM in participants with grade s I and II obesity . DESIGN , SETTING , AND PARTICIPANTS A 12-month , 3-arm RCT at a single center including 69 participants aged 25 to 55 years with a body mass index ( calculated as weight in kilograms divided by height in meters squared ) of 30 to 40 and T2DM . INTERVENTIONS Roux-en-Y gastric bypass ( RYGB ) , laparoscopic adjustable gastric b and ing ( LAGB ) , and an intensive lifestyle weight loss intervention ( LWLI ) . MAIN OUTCOMES AND MEASURES Primary outcomes in the intention-to-treat cohort were feasibility and effectiveness measured by weight loss and improvements in glycemic control . RESULTS Of 667 potential participants who underwent screening , 69 ( 10.3 % ) were r and omized . Among the r and omized participants , 30 ( 43 % ) had grade I obesity , and 56 ( 81 % ) were women . Mean ( SD ) age was 47.3 ( 6.4 ) years and hemoglobin A1c level , 7.9 % ( 2.0 % ) . After r and omization , 7 participants ( 10 % ) refused to undergo their allocated intervention ( 3 RYGB , 1 LAGB , and 3 LWLI ) , and 1 RYGB participant was excluded for current smoking . Twenty participants underwent RYGB ; 21 , LAGB ; and 20 , LWLI , with 12-month retention rates of 90 % , 86 % , and 70 % , respectively . In the intention-to-treat cohort with multiple imputation for missing data , RYGB participants had the greatest mean weight loss from baseline ( 27.0 % ; 95 % CI , 30.8 - 23.3 ) compared with LAGB ( 17.3 % ; 95 % CI , 21.1 - 13.5 ) and LWLI ( 10.2 % ; 95 % CI , 14.8 - 5.61 ) ( P < .001 ) . Partial and complete remission of T2DM were 50 % and 17 % , respectively , in the RYGB group and 27 % and 23 % , respectively , in the LAGB group ( P < .001 and P = .047 between groups for partial and complete remission ) , with no remission in the LWLI group . Significant reductions in use of antidiabetics occurred in both surgical groups . No deaths were noted . The 3 serious adverse events included 1 ulcer treated medically in the RYGB group and 2 rehospitalizations for dehydration in the LAGB group . CONCLUSIONS AND RELEVANCE This study highlights several potential challenges to successful completion of a larger RCT for treatment of T2DM and obesity in patients with a body mass index of 30 to 40 , including the difficulties associated with recruiting and r and omizing patients to surgical vs nonsurgical interventions . Preliminary results show that RYGB was the most effective treatment , followed by LAGB for weight loss and T2DM outcomes at 1 year . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01047735 Aims /hypothesisBariatric surgery is gaining acceptance as a ‘ metabolic surgical intervention ’ for patients with type 2 diabetes . The optimal form of surgery and the mechanism of action of these procedures are much debated . We compared two bariatric procedures for obese patients with type 2 diabetes and evaluated their effects on HbA1c and glucose tolerance . Methods We performed a parallel un-blinded r and omised trial of Roux-en-Y gastric bypass ( RYGB ) vs sleeve gastrectomy ( SG ) in 41 obese patients with type 2 diabetes , who were bariatric surgery c and i date s attending the obesity clinic .  HbA1c , body composition and glucose tolerance were evaluated at baseline , and at 3 and 12 months . Results Of the 41 patients , 37 completed the follow-up ( 19 RYGB , 18 SG ) . Both groups had similar baseline anthropometric and biochemical measures , and showed comparable weight loss and fat : fat-free mass ratio changes at 12 months . A similar normalisation of HbA1c levels was observed as early as 3 months post-surgery ( 6.37 ± 0.71 % vs 6.23 ± 0.69 % for RYGB vs SG respectively , p < 0.001 in both groups for baseline vs follow-up ) . Conclusions /interpretationIn this study , RYGB did not have a superior effect in comparison to SG with regard to HbA1c levels or weight loss during 12 months of follow-up . Trial registration Clinical Trials.gov NCT00667706 Funding This work was supported by grant no. 3 - 000 - 8480 from the Israel Ministry of Health Chief Scientist , the Stephen Morse Diabetes Research Foundation and by Johnson & Johnson AIMS The aim of this study was to evaluate the effect of laparoscopic Roux-en-Y gastric bypass ( RYGB ) surgery compared with usual care with and without Exenatide therapy in obese people with type 2 diabetes mellitus ( T2DM ) and hypertension . METHODS 108 obese T2DM with hypertension were enrolled and r and omly allocated to usual care ( group A ) , usual care plus Exenatide ( group B ) , and RYGB surgery ( group C ) . Demographic characteristics , metabolic parameters and cardiac structure/function along with inflammatory cytokines were measured and compared before and after 12 months . RESULTS At 12 months , diabetes remission had occurred in no patients in groups A and B versus 90 % in group C , and there was a significant decrease in requirement of antihypertensive drugs in group C compared with groups A and B ( P<0.05 ) . Other parameters ( body mass index , hemoglobin A1c , homeostasis model assessment of insulin resistance , lipids ) , inflammation index ( high sensitivity C-reactive protein , tumor necrosis factor-α , high molecular weight adiponectin ) and cardiac structure ( left ventricular mass index ) were significantly improved in groups B and C , but patients in group C had the greatest degree of improvement ( P<0.05 ) . CONCLUSION RYGB surgery improves a number of parameters including cardiovascular function in obese hypertensive people with T2DM . This is likely to be due to , at least in part , an improvement in the abnormal metabolic panel and to reduced inflammation Introduction Type 2 diabetes ( T2D ) in association with obesity is an increasing disease burden . Bariatric surgery is the only effective therapy for achieving remission of T2D among those with morbid obesity . It is unclear which of the two most commonly performed types of bariatric surgery , laparoscopic sleeve gastrectomy ( LSG ) and laparoscopic Roux-en-Y gastric bypass ( LRYGB ) , is most effective for obese patients with T2D . The primary objective of this study is to determine whether LSG or LRYGB is more effective in achieving HbA1c<6 % ( < 42 mmol/mol ) without the use of diabetes medication at 5 years . Methods and analysis Single-centre , double-blind ( assessor and patient ) , parallel , r and omised clinical trial ( RCT ) conducted in New Zeal and , targeting 106 patients . Eligibility criteria include age 20–55 years , T2D of at least 6 months duration and body mass index 35–65 kg/m2 for at least 5 years . R and omisation 1:1 to LSG or LRYGB , used r and om number codes disclosed to the operating surgeon after induction of anaesthesia . A st and ard medication adjustment schedule will be used during postoperative metabolic assessment s. Secondary outcomes include proportions achieving HbA1c<5.7 % ( 39 mmol/mol ) or HbA1c<6.5 % ( 48 mmol/mol ) without the use of diabetes medication , comparative weight loss , obesity-related comorbidity , operative complications , revision rate , mortality , quality of life , anxiety and depression scores . Exploratory outcomes include changes in satiety , gut hormone and gut microbiota to gain underlying mechanistic insights into T2D remission . Ethics and dissemination Ethics approval was obtained from the New Zeal and regional ethics committee ( NZ93405 ) who also provided independent safety monitoring of the trial . Study commenced in September 2011 . Recruitment completed in October 2014 . Data collection is ongoing . Results will be reported in manuscripts su bmi tted to peer- review ed journals and in presentations at national and international meetings . Trial registration numbers ACTRN12611000751976 , NCT01486680 ; Pre- results BACKGROUND Laparoscopic Roux-en-Y gastric bypass ( LRYGB ) and laparoscopic sleeve gastrectomy ( LSG ) are associated with glucose metabolism improvement although data on insulin resistance remission rates after these procedures are lacking . AIMS Primary aim was to compare insulin resistance remission rates achieved after LRYGB and LSG , using population -specific HOMA-IR cut-off points . Secondary objectives were to analyze factors associated with type 2 diabetes mellitus ( T2DM ) complete remission according to the new American Diabetes Association criteria and to examine changes in HOMA-B during follow-up . METHODS Non-r and omized , prospect i ve cohort study of patients undergoing LRYGB or LSG with a minimal follow-up of 24 months . Patients on insulin therapy were excluded . RESULTS At baseline , 56 ( 48.7 % ) of the 115 LRYGB group and 48 ( 61.5 % ) of the 78 LSG group had insulin resistance , and 29 ( 25.2 % ) and 20 ( 25.6 % ) T2DM , respectively . No differences were detected in insulin resistance remission rate ( 92.9 % LRYGB and 87.5 % LSG , p = 0.355 ) nor in T2DM complete remission at 2 years ( 62.1 vs 60 % respectively , p = 0.992 ) . Factors independently associated with T2DM complete remission were diabetes treatment and a greater decrease in 3-month HOMA-IR index . The HOMA-B index showed a progressive decline during follow-up . CONCLUSION Both surgical techniques are equally effective in achieving insulin resistance normalization in the majority of severely obese patients . Three-month HOMA-IR reduction after surgery was the main predictor of T2DM complete remission Background Laparoscopic Roux-en-Y gastric bypass ( LRYGB ) can dramatically ameliorate  type 2 diabetes mellitus ( T2DM ) in morbidly obese patients . However , there is little evidence supporting the effectiveness of LRYGB in low body mass index ( BMI ) patients . The study was design ed to evaluate the safety and results of LRYGB for achieving T2DM remission in patients with BMI in the range of 25–35 kg/m2 . Methods Twenty-two patients ( two men and 20 women ) with T2DM underwent LRYGB .  Data on patient demographics , BMI , co-morbidities , and details of diabetes mellitus , including disease duration , family history , medication use , and remission , were prospect ively collected and analyzed . Results The mean age was 47 years ( range , 28–63 years ) , mean BMI was 30.81 ( range , 25.00–34.80 kg/m2 ) , and mean duration of T2DM onset was 6.57 years ( range , 1–20 years ) . Sixteen ( 72.27 % ) patients had a family history of T2DM . There was no mortality , but two ( 9 % ) patients experienced complications : an early gastrojejunostomy hemorrhage and frequent loose stools that required revision surgery . At 12 months , 14 ( 63.6 % ) patients showed T2DM remission , six ( 27.3 % ) showed glycemic control , and two ( 9.1 % ) showed improvement . The group achieving remission had a higher BMI ( p = 0.001 ) , younger age ( p = 0.002 ) , and shorter duration of diabetes ( p = 0.001 ) . These three factors may be predictors of diabetes resolution at 12 months . Conclusion Early intervention in low- BMI patients yields better remission rates because age , BMI , and duration of T2DM predict glycemic outcomes Objective To evaluate the impact of Roux-en-Y gastric bypass ( RYGB ) on quality of life in obese diabetic patients compared to st and ard medical therapy for type 2 diabetes mellitus . Methods We prospect ively studied two matched obese population s with type 2 diabetes . Thirty patients underwent laparoscopic RYGB and 31 received st and ard medical therapy combined with a diabetes support and education program ( DSE ) , consisting of educational sessions on diet and exercise . Groups were matched by age , gender , weight , glucostatic parameters , and use of glucose-lowering medications ( oral agents and insulin therapy ) . Health-related quality of life ( HRQOL ) was assessed using the normalized SF-36 question naire , and data were collected at baseline and at 12-month follow-up . Results Diabetic patients who underwent RYGB experienced a statistically significant increase in their overall HRQOL . However , the role-physical and mental health domains increased but did not reach statistical significance . Diabetic patients in the medical therapy and DSE group did not show any significant increase in HRQOL . The between-group differences for the HRQOL changes from baseline were significant , other than for role-physical and mental health domains . Percentage changes in glucostatic parameters , discontinuation of glucose-lowering medications , and T2DM remission were not found to predict the percentage change in SF-36 scores at 12 months after RYGB . Conclusions For the first time , with a prospect i ve matched control study , we demonstrate a significant improvement in HRQOL in obese diabetic patients who underwent RYGB , but not in those who were offered st and ard medical therapy and DSE Background To compare long term effects of two bariatric procedures for Chinese type 2 diabetes mellitus ( T2DM ) patients with a body mass index ( BMI ) of 28 - 35 kg/m2 . Methods Sixty four T2DM patients with Glycated hemoglobin A1c ( HbA1c ) ≧ 7.0 % were r and omly assigned to receive laparoscopic sleeve gastrectomy ( SG ) or Roux-en-Y gastric bypass ( RYGB ) procedure . Weight , percentage of excess weight loss ( % EWL ) , BMI , waist circumference , HbA1c , fasting blood glucose ( FBG ) , and C-peptide were measured . Serum lipid levels were also measured during three-year postoperative follow-up visits . Results Fifty five patients completed the 36-month follow-up . Both groups had similar baseline anthropometric and biochemical measures . At the end point , 22 patients ( 78.6 % ) in SG group and 23 patients ( 85.2 % ) in RYGB group achieved complete remission of diabetes mellitus with HbA1c < 6.0 % ( P = 0.525 ) and without taking diabetic medications , and 25 patients in each group ( 89.3 % vs. 92.6 % ) gained successful treatment of diabetes with HbA1c≦6.5 % ( P = 0.100 ) . Change in HbA1c , FBG and C peptide were comparable in the two groups . The RYGB group had significantly greater weight loss than the SG group [ percentage of total weight loss ( % TWL ) of 31.0 % vs. 27.1 % ( P = 0.049 ) , % EWL of 92.3 % vs. 81.9 % ( P = 0.003 ) , and change in BMI of 11.0 vs. 9.1 kg/m2(P = 0.017 ) , respectively ] . Serum lipids in each group were also greatly improved . Conclusion In this three-year study , SG had similar positive effects on diabetes and dyslipidemia compared to RYGB in Chinese T2DM patients with BMI of 28 - 35 kg/m2 . Longer term follow-ups and larger sample studies are needed to confirm these outcomes , however IMPORTANCE Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus ( T2DM ) . OBJECTIVE To compare the remission of T2DM following surgical and nonsurgical treatments . DESIGN , SETTING , AND PARTICIPANTS In this 3-arm r and omized clinical trial conducted at the University of Pittsburgh Medical Center from October 1 , 2009 , to June 26 , 2014 , in Pittsburgh , Pennsylvania , outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM . Analysis was conducted with an intent-to-treat population . INTERVENTIONS Participants were r and omized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments ( Roux-en-Y gastric bypass [ RYGB ] or laparoscopic adjustable gastric b and ing [ LAGB ] ) followed by low-level lifestyle intervention in years 2 and 3 . MAIN OUTCOMES AND MEASURES Primary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change . RESULTS Body mass index ( calculated as weight in kilograms divided by height in meters squared ) was less than 35 for 26 participants ( 43 % ) , 50 ( 82 % ) were women , and 13 ( 21 % ) were African American .  Mean ( SD ) values were 100.5 ( 13.7 ) kg for weight , 47.3 ( 6.6 ) years for age , 7.8 % ( 1.9 % ) for hemoglobin A1c level , and 171.3 ( 72.5 ) mg/dL for fasting plasma glucose level . Partial or complete T2DM remission was achieved by 40 % ( n = 8) of RYGB , 29 % ( n = 6 ) of LAGB , and no intensive lifestyle weight loss intervention participants ( P = .004 ) . The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention-alone group , with 65 % of RYGB , 33 % of LAGB , and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 ( P < .001 ) . Mean ( SE ) reductions in percentage of body weight at 3 years were the greatest after RYGB at 25.0 % ( 2.0 % ) , followed by LAGB at 15.0 % ( 2.0 % ) and lifestyle treatment at 5.7 % ( 2.4 % ) ( P < .01 ) . CONCLUSIONS AND RELEVANCE Among obese participants with T2DM , bariatric surgery with 2 years of an adjunctive low-level lifestyle intervention result ed in more disease remission than did lifestyle intervention alone . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01047735 BACKGROUND Roux-en-Y gastric bypass ( RYGBP ) and sleeve gastrectomy ( SG ) have been associated with a high remission rate of type 2 diabetes mellitus ( T2DM ) . However , whether such remission is associated with full restoration of postpr and ial glucose profile and /or the potentially nonrestored glycemic profile is associated with altered beta cell function , and relapse of T2DM over time is unknown . METHODS Cross-sectional studies comparing ( 1 ) glucose and proinsulin/insulin response to a st and ardized liquid mixed meal ( SLMM ) challenge  ( n = 31 ) , ( 2 ) glucose response in normal living conditions assessed using continuous glucose monitoring ( CGM ) ( n = 16 ) , and prospect i ve observational study comparing ( 3 ) rates of relapse of T2DM after surgery ( n = 232 ) in subjects with remission of T2DM ensuing RYGBP or SG . RESULTS In  RYGB individuals , SLMM elicited faster and sharper rise in plasma glucose compared with SG , with 88.2 % and 42.9 % of the study subjects presenting respectively a peak glucose more than 180 mg/dL ( all , P < 0.05 ) . During CGM , average percent time in hyperglycemic and hypoglycemic range was larger in RYGBP ( respectively , 4.6 % and 12.7 % ) compared with SG subjects ( respectively , 0.4 % and 3.2 % ; both P < 0.05 ) . However , ( 1 ) no differences were found in fasting or stimulated proinsulin/insulin ratio , and ( 2 ) higher rates of T2DM relapse were observed after SG ( hazard ratio : 2.339 ; P = 0.034 ) . CONCLUSIONS Remission of T2DM after RYGBP and SG is associated with distinct glycemic profiles . However , longer time spent in hyperglycemia and in hypoglycemia after RYGBP compared with SG is not associated with persistence of altered beta cell function or higher rates of relapse of T2DM over time The profound effects of bariatric surgery on glycemic control are well established in many studies , including several r and omized trials that compared surgery versus intensive medical and lifestyle treatment of type 2 diabetes mellitus ( T2DM ) ( 17 ) . Remission of T2DM is common after bariatric surgery , and Roux-en-Y gastric bypass ( RYGB ) outperforms sleeve gastrectomy ( SG ) in most reports ( 4 , 8 , 9 ) . More important than improvements in glycemic control is whether these glycemic changes reduce the incidence of major complications , such as microvascular events . In the United States , T2DM is the primary cause of nephropathy , end-stage renal disease , adult blindness , and neuropathy , which together lead to significant downstream costs and decreased quality of life ( 1012 ) . Thus , a major goal of diabetes treatment is to mitigate the risk for these long-term sequelae ( 13 ) . We have previously shown that in patients with T2DM who have bariatric surgery  , risk for incident microvascular disease is reduced for every year of remission from T2DMeven if patients eventually relapse back to T2DM ( indicating a legacy effect ) ( 14 ) . However , a detailed 2016 review of long-term microvascular outcomes of diabetes concluded that data were inadequate to support a superior effect of bariatric surgery compared with medical therapy ( 15 ) . Two recently published studies help inform this question ( 4 , 16 ) . The STAMPEDE ( Surgical Therapy and Medications Potentially Eradicate Diabetes Efficiently ) trial ( 4 ) r and omly assigned 150 patients with obesity and T2DM to have RYGB , SG , or an intensive medical and lifestyle intervention . After 5 years , urinary albumincreatinine ratios had decreased in the SG group only . Retinopathy did not change in any group , and neuropathy was not examined . STAMPEDE was limited by a relatively small sample size , which made it underpowered for rare outcomes . The prospect i ve SOS ( Swedish Obesity Subjects ) matched cohort study ( 16 ) followed 2010 patients who had bariatric surgery ( 13 % RYGB , 19 % gastric b and ing , and 68 % vertical-b and ed gastroplasty ) and 2037 matched patients who received usual care .  The incidence of microvascular disease after 15 years of follow-up was significantly lower in the surgery group than the control group ( hazard ratio [ HR ] , 0.56 [ 95 % CI , 0.48 to 0.66 ] ) , including among subgroups with prediabetes ( HR , 0.18 [ CI , 0.11 to 0.30 ] ) , established diabetes ( HR , 0.54 [ CI , 0.40 to 0.72 ] ) , and normoglycemia ( HR , 0.63 [ CI , 0.48 to 0.81 ] ) at baseline . The SOS study was limited by the small number of RYGB procedures and lack of SG procedures , which are now the 2 most common bariatric procedures worldwide ( 17 ) . To address these gaps in the literature , we did a matched cohort study to determine whether bariatric surgery was associated with lower incidence of microvascular disease than usual care for severe obesity and T2DM . We hypothesized that patients having  bariatric surgery would have lower risk for any incident microvascular disease ( composite of the first occurrence of retinopathy , neuropathy , or nephropathy ) . We further hypothesized that patients having bariatric surgery would have lower risk for incident retinopathy , nephropathy , and neuropathy than nonsurgical patients . Methods Setting s We did a retrospective observational cohort study of adults with T2DM who had bariatric surgery between 2005 and 2011 while enrolled in 1 of 4 integrated health care systems from the Health Care Systems Research Network : Kaiser Permanente ( KP ) Washington in Washington state , HealthPartners in Minnesota , KP Northern California , and KP Southern California . All study procedures were review ed and approved by the institutional review board at each site , and we were permitted to do the research without explicit consent from participants . Data Sources At each study site , staff used st and ardized electronic medical records , insurance cl aims , and other data systems ( 18 ) to extract enrollee data , including enrollment and insurance coverage ; demographics ; blood pressure ; height ; weight ; laboratory values ; medications dispensed ; deaths ; outpatient , inpatient , and emergency department use ; and inpatient and outpatient diagnosis and procedure codes . Surgical Participants The bariatric population included adults ( aged 19 to 79 years ) with severe obesity ( body mass index [ BMI ] 35 kg/m2 ) and T2DM who had a primary ( first observed ) bariatric surgical procedure between 1 January 2005 and 31 December 2011 . Following an approach adopted in prior studies ( 14 , 19 , 20 ) , we used a combination of bariatric registries ; review of medical records ; codes from the International Classification of Diseases , Ninth Revision ( ICD-9 ) ( 43.89 , 44.31 , 44.38 , 44.39 , 44.68 , 44.69 , and 44.95 ) ; and Current Procedural Terminology codes ( 43633 , 43644 , 43645 , 43659 , 43770 , 43775 , 43842 , 43843 , 43844 , 43845 , 43846 , and 43847 ) to identify bariatric procedures .  Patients were classified as having T2DM if they had a hemoglobin A1c ( HbA1c ) level of at least 6.5 % or fasting plasma glucose level of at least 6.99 mmol/L ( 126 mg/dL ) at the most recent measurement within 2 years before surgery , or a current prescription for any diabetes medication . After selecting the population , we applied the following exclusion criteria based on information in the 2 years before surgery : less than 1 full year of continuous enrollment ; history of gastrointestinal surgery for cancer ; pregnancy in the year before surgery ; gestational diabetes as the sole diabetes diagnosis ; metformin as the sole indicator of possible T2DM ( that is , no other T2DM medications , laboratory values , or diagnoses ) ; preexisting neuropathy , retinopathy , or nephropathy ( defined in Outcome and Censoring Definitions ) ; and maximum preoperative BMI less than 35 kg/m2 . This left 4972 patients . We further excluded 850 patients who were missing values for BMI , HbA1c level , or serum creatinine concentration in the 2 years before surgery . Surgical patients who were missing these values differed from those who had complete data ( Appendix Table 1 ) . Specifically , they were more likely to be non-Hispanic white , to be from the HealthPartners site , to have had their procedure in the first year of our study ( 2005 ) , and to have had a shorter observed duration of T2DM at the time of surgery . Of the remaining 4122 patients , 4024 could be matched to at least 1 nonsurgical patient ( Figure 1 ) . Figure 1 . Flow diagram for identification of eligible patients with T2DM and no history of microvascular disease who had bariatric surgery .  BMI = body mass index ; EHR= electronic health record ; HbA1c= hemoglobin A1c ; T2DM= type 2 diabetes mellitus . * Adults aged 2079 y who had a primary ( first observed ) bariatric surgical procedure between 1 January 2005 and 31 December 2011 .  Bariatric procedures were identified using a combination of bariatric registries ; review of medical records ; International Classification of Diseases , Ninth Revision , codes ( 43.89 , 44.31 , 44.38 , 44.39 , 44.68 , 44.69 , and 44.95 ) ; and Current Procedural Terminology codes ( 43633 , 43644 , 43645 , 43659 , 43770 , 43775 , 43842 , 43843 , 43844 , 43845 , 43846 , and 43847 ) . We excluded patients with any of the following : < 1 y of continuous enrollment ; history of gastrointestinal surgery for cancer ; pregnancy in the year before surgery ; gestational diabetes as the sole diabetes diagnosis ; preexisting neuropathy , nephropathy , or retinopathy ; metformin as the sole indicator of possible T2DM ( no other T2DM medications , laboratory values , or diagnoses ) ; or maximum BMI < 35 kg/m2 . Patients may have > 1 type of missing data ( BMI , creatinine concentration , or HbA1c level ) or have no follow-up time after surgery . 98 surgical patients could not be matched to a nonsurgical patient on site , age , BMI , insulin use , HbA1c level , and sex . Appendix Table 1 . Comparison of Characteristics of Surgical Patients Who Were Missing Values for BMI , HbA1c , or Serum Creatinine at Baseline Versus Those Who Had Complete Information on These Values at Baseline Matched Nonsurgical Participants For each surgical patient , we identified up to 3 matched nonsurgical control participants via a 2-step process . First , among all patients with diabetes and at least 1 BMI measurement of 35 kg/m2 or greater who did not have bariatric surgery during the study ( n= 320345 ) , we identified a pool of potential control participants who were enrolled at the time of the surgery ; satisfied the study inclusion criteria ; and matched the surgical patient on the basis of study site , sex , age ( 10 years ) , BMI ( 5 kg/m2 ) , HbA1c level ( 1.5 percentage points ) , and insulin use . Second , for each control participant in the pool , we calculated Mahalanobis distance from the surgical patient on the basis of age , BMI , HbA1c level , diabetes duration , and total days of health care use in the 7 to 24 months before the date of surgery ( 21 ) . Finally , up to 3 control participants were selected on the basis of the shortest Mahalanobis distance . Throughout , nonsurgical patients could be used as a control for only 1 surgical patient ( matching without replacement ) . The Appendix gives additional details on the process we used to establish the matched cohort . Outcome and Censoring Definitions The primary outcome measure was time to incident microvascular disease ( composite of the first occurrence of retinopathy , neuropathy , or nephropathy ) . Retinopathy was defined by the first appearance of either ICD-9 code 362.0x ( diabetic retinopathy ) or both a retinal surgical procedure code or other retinopathic code ( Appendix Table 2 ) and ICD-9 code 250.5x ( diabetes with ophthalmic manifestations ) . Neuropathy was identified on the basis of the first occurrence of ICD-9 code 250.6 ( diabetes with neurologic manifestations ) or 357.2 ( polyneuropathy in diabetes ) . Finally , nephropathy was defined by at least 2 measures of estimated glomerular filtration rate less than 60 mL/min/1.73 m2 separated by at least 90 days without any intervening values of 60 mL/min/1.73 m2 or greater . We approximated BACKGROUND Obesity is a rising threat to public health . The relative increase in the incidence of morbid obesity is most pronounced in the most severely obese .  Roux-en-Y gastric bypass ( RYGB ) results in inferior weight loss in this group . Therefore , we have offered biliopancreatic diversion with duodenal switch ( BPD/DS ) as an alternative for this patient category . Our objective was to compare BPD/DS and RYGB in the surgical treatment of morbid obesity in patients with a body mass index ( BMI ) > 48 kg/m(2 ) . The setting was a university hospital in Sweden . METHODS In a controlled trial ( registration number IS RCT N10940791 ) , 47 patients ( 25 men , BMI 54.5 ± 6.1 kg/m(2 ) ) were r and omized to RYGB ( n = 23 ) or BPD/DS ( n = 24 ) . Biochemical data were collected preoperatively and 1 and 3 years postoperatively . A question naire addressing weight , general satisfaction , and gastrointestinal symptoms was distributed a median of 4 years postoperatively . RESULTS Both procedures were safe . The duration of surgery and postoperative morphine consumption were greater after BPD/DS than after RYGB ( 157 versus 117 min and 140 versus 93 mg , respectively ) . BPD/DS result ed in greater weight loss  than RYGB ( -23.2 ± 4.9 versus -16.2 ± 6.9 BMI units or 80 % ± 15 % versus 51 % ± 23 % excess BMI loss , P < .001 ) . BPD/DS  yielded lower glucose and glycated hemoglobin levels at 3 years . More patients listed troublesome diarrhea and malodorous flatus in the question naire after BPD/DS , but no significant difference was seen ( P = .078 and P = .073 , respectively ) . CONCLUSIONS BPD/DS produced superior weight results and lower glycated hemoglobin levels compared with RYGB in patients with a BMI > 48 kg/m(2 ) . Both operations yield high satisfaction rates . However , diarrhea tended to be more common after BPD/DS IMPORTANCE Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus . OBJECTIVE To test the feasibility of methods to conduct a larger multisite trial to determine the long-term effect of Roux-en-Y gastric bypass ( RYGB ) surgery compared with an intensive diabetes medical and weight management ( Weight Achievement and Intensive Treatment [ Why WAIT ] ) program for type 2 diabetes . DESIGN , SETTING , AND PARTICIPANTS A 1-year pragmatic r and omized clinical trial was conducted in an academic medical institution . Participants included persons aged 21 to 65 years with type 2 diabetes diagnosed more than 1 year before the study ; their body mass index was 30 to 42 ( calculated as weight in kilograms divided by height in meters squared ) and hemoglobin A1c ( HbA1c ) was greater than or equal to 6.5 % . All participants were receiving antihyperglycemic medications . INTERVENTIONS RYGB ( n = 19 ) or Why WAIT ( n = 19 ) including 12 weekly multidisciplinary group lifestyle , medical , and educational sessions with monthly follow-up thereafter . MAIN OUTCOMES AND MEASURES Proportion of patients with fasting plasma glucose levels less than 126  mg/dL  and HbA1c less than 6.5 % , measures of cardiometabolic health , and patient-reported outcomes . RESULTS At 1 year , the proportion of patients achieving HbA1c below 6.5 % and fasting glucose below 126 mg/dL was higher following RYGB than Why WAIT ( 58 % vs 16 % , respectively ; P = .03 ) . Other outcomes , including HbA1c , weight , waist circumference , fat mass , lean mass , blood pressure , and triglyceride levels , decreased and high-density lipoprotein cholesterol increased more after RYGB compared with Why WAIT . Improvement in cardiovascular risk scores was greater in the surgical group . At baseline the participants exhibited moderately low self-reported quality -of-life scores reflected by Short Form-36 total , physical health , and mental health , as well as high Impact of Weight on Quality of Life-Lite and Problem Areas in Diabetes health status scores . At 1 year , improvements in Short Form-36 physical and mental health scores and Problem Areas in Diabetes scores did not differ significantly between groups . The Impact of Weight on Quality of Life-Lite score improved more with RYGB and correlated with greater weight loss compared with Why WAIT . CONCLUSIONS AND RELEVANCE In obese patients with type 2 diabetes , RYGB produces greater weight loss and sustained improvements in HbA1c and cardiometabolic risk factors compared with medical management , with emergent differences over 1 year . Both treatments improve general quality -of-life measures , but RYGB provides greater improvement in the effect of weight on quality of life . These differences may help inform therapeutic decisions for diabetes and weight loss strategies in obese patients with type 2 diabetes until larger r and omized trials are performed . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01073020 BACKGROUND Roux-en-Y gastric bypass ( RYGB ) surgery causes profound weight loss and improves insulin sensitivity ( S(I ) ) in obese patients .  Regular exercise can also improve S(I ) in obese individuals ; however , it is unknown whether exercise and RYGB surgery-induced weight loss would additively improve S(I ) and other cardiometabolic factors . METHODS We conducted a single-blind , prospect i ve , r and omized trial with 128 men and women who recently underwent RYGB surgery ( within 1 - 3 months ) . Participants were r and omized to either a 6-month semi-supervised moderate exercise protocol ( EX , n = 66 ) or a health education control ( CON ; n = 62 ) intervention . Main outcomes measured included S(I ) and glucose effectiveness ( S(G ) ) , which were determined from an intravenous glucose tolerance test and minimal modeling . Secondary outcomes measured were cardiorespiratory fitness ( VO2 peak ) and body composition . Data were analyzed using an intention-to-treat ( ITT ) and per- protocol ( PP ) approach to assess the efficacy of the exercise intervention ( > 120 min of exercise/week ) . RESULTS 119 ( 93 % ) participants completed the interventions , 95 % for CON and 91 % for EX . There was a significant decrease in body weight and fat mass for both groups ( P < 0.001 for time effect ) . S(I ) improved in both groups following the intervention ( ITT : CON vs. EX ; + 1.64 vs. + 2.24 min⁻¹/μU/ml , P = 0.18 for Δ , P < 0.001 for time effect ) . A PP analysis revealed that exercise produced an additive S(I ) improvement ( PP : CON vs. EX ; + 1.57 vs. + 2.69 min⁻¹/μU/ml , P = 0.019 ) above that of surgery . Exercise also improved S(G ) ( ITT : CON vs. EX ; + 0.0023 vs. + 0.0063 min⁻¹ , P = 0.009 ) compared with the CON group . Exercise improved cardiorespiratory fitness ( VO2 peak ) compared with the CON group . CONCLUSION Moderate exercise following RYGB surgery provides additional improvements in S(I ) , S(G ) , and cardiorespiratory fitness compared with a sedentary lifestyle during similar weight loss . TRIAL REGISTRATION clinical trials.gov identifier : NCT00692367 . FUNDING This study was funded by the NIH/National Institute of Diabetes and Digestive and Kidney Diseases ( R01 DK078192 ) and an NIH/National Center for Research Re sources / Clinical and Translational Science Award ( UL1 RR024153 ) Background Roux-en-Ygastric bypass ( RYGB ) and sleeve gastrectomy ( SG ) rank among the most frequently applied bariatric procedures worldwide due to their positive risk/benefit correlation . A systematic review revealed a similar excess weight loss ( EWL ) 2 years postoperatively between SG and RYGB . However , there is a lack of r and omized controlled multi-centre trials comparing SG and RYGB , not only concerning EWL , but also in terms of remission of obesity-related co-morbidities , gastroesophageal reflux disease ( GERD ) and quality of life ( QoL ) in the mid- and long-term . Methods The BariSurg trial was design ed as a multi-centre , r and omized controlled patient and observer blind trial . The trial protocol was approved by the corresponding ethics committees of the centres . To demonstrate EWL non-inferiority of SG compared to RYGB , power calculation was performed according to a non-inferiority study design . Morbidity , mortality , remission of obesity-related co-morbidities , GERD course and QoL are major secondary endpoints . 248 patients between 18 and 70 years , with a body mass index ( BMI ) between 35–60 kg/m2 and indication for bariatric surgery according to the most recent German S3- guidelines will be r and omized . The primary and secondary endpoints will be assessed prior to surgery and afterwards at discharge and at the time points 3–6 , 12 , 24 , 36 , 48 and 60 months postoperatively . Discussion With its five year follow-up , the BariSurg-trial will provide further evidence based data concerning the impact of SG and RYGB on EWL , remission of obesity-related co-morbidities , the course of GERD and QoL.Trial registration The trial protocol has been registered in the German Clinical Trials Register DRKS00004766
The medicine use and quality of life were solely improved in the surgical group .
Nutritional deficiencies and anemia were noted more frequently in the RYGB group .
RYGB surgery is superior to medical treatment for short- to medium-term remission of T2DM , improvement of metabolic condition , and cardiovascular risk factors .
Abstract The aim of the study is to compare Roux-en-Y gastric bypass ( RYGB ) surgery versus medical treatment for  type 2 diabetes mellitus ( T2DM ) in obese patients .Bariatric  surgery can achieve remission of T2DM in obese patients .
RYGB surgery has been performed as one of the most common surgical treatment options for obese patients with T2DM , but the efficacy of RYGB surgery comparing with medical treatment alone has not been conclusively determined .