Randomized Pilot Trial of Bariatric Surgery Versus Intensive Medical Weight Management on Diabetes Remission in Type 2 Diabetic Patients Who Do NOT Meet NIH Criteria for Surgery and the Role of Soluble RAGE as a Novel Biomarker of Success Effect of Laparoscopic Mini-Gastric Bypass for Type 2 Diabetes Mellitus: Comparison of BMI >35 and <35 kg/m2 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 Safety and Efficacy of Roux-en-Y Gastric Bypass to Treat Type 2 Diabetes Mellitus in Non-severely Obese Patients Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial. Diabetes remission and reduced cardiovascular risk after gastric bypass in Asian Indians with body mass index <35 kg/m(2). Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial. Laparoscopic Roux-en-Y Gastric Bypass for the Treatment of Type II Diabetes Mellitus in Chinese Patients with Body Mass Index of 25–35 Diabetes Remission and Insulin Secretion After Gastric Bypass in Patients with Body Mass Index <35 kg/m2 Predictive Factors of Type 2 Diabetes Remission 1 Year After Bariatric Surgery: Impact of Surgical Techniques Sleeve gastrectomy and Roux-en-Y gastric bypass are equally effective in correcting insulin resistance. 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 Health outcomes of severely obese type 2 diabetic subjects 1 year after laparoscopic adjustable gastric banding. Adjustable gastric banding and conventional therapy for type 2 diabetes: 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 Gastric bypass vs sleeve gastrectomy for type 2 diabetes mellitus: a randomized controlled trial. Microvascular Outcomes in Patients With Diabetes After Bariatric Surgery Versus Usual Care
Objective : To compare bariatric surgery versus intensive medical weight management ( MWM ) in patients with type 2 diabetes mellitus ( T2DM ) who do not meet current National Institutes of Health criteria for bariatric surgery and to assess whether the soluble form of receptor for advanced glycation end products ( sRAGE ) is a biomarker to identify patients most likely to benefit from surgery . Background : There are few studies comparing surgery to MWM for patients with T2DM and BMI less than 35 . Methods : Fifty-seven patients with T2DM and BMI 30 to 35 , who otherwise met the criteria for bariatric surgery were r and omized to MWM versus surgery ( bypass , sleeve or b and , based on patient preference ) . The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance ( HOMA-IR ) and diabetes remission . Secondary outcomes included changes in HbA1c , weight , and sRAGE . Results : The surgery group had improved HOMA-IR ( −4.6 vs + 1.6 ; P = 0.0004 ) and higher diabetes remission ( 65 % vs 0 % , P < 0.0001 ) than the MWM group at 6 months . Compared to MWM , the surgery group had lower HbA1c ( 6.2 vs 7.8 , P = 0.002 ) , lower fasting glucose ( 99.5 vs 157 ; P = 0.0068 ) , and fewer T2DM medication requirements ( 20 % vs 88 % ; P < 0.0001 ) at 6 months . The surgery group lost more weight ( 7 . vs 1.0 BMI decrease , P < 0.0001 ) . Higher baseline sRAGE was associated with better weight loss outcomes ( r = −0.641 ; P = 0.046 ) . There were no mortalities . Conclusions : Surgery was very effective short-term in patients with T2DM and BMI 30 to 35 . Baseline sRAGE may predict patients most likely to benefit from surgery . These findings need to be confirmed with larger studies . Clinical Trials.gov ID : Background Laparoscopic gastric bypass result ed in significant weight loss and resolution of type 2 diabetes mellitus ( T2DM ) .  The current indication for bariatric surgery is mainly applied for patients with body mass index ( BMI ) > 35 kg/m2 with comorbidity status . However , little is known concerning T2DM patients with BMI < 35 kg/m2 . Recent studies have suggested that T2DM patients with BMI < 35 kg/m2 might benefit from gastric bypass surgery . Methods From Jan 2002 to Dec 2006 , 820 patients who underwent laparoscopic mini-gastric bypass were enrolled in a surgically supervised weight loss program .  We identified 201 ( 24.5 % ) patients who had impaired fasting glucose or T2DM . All the clinical data were prospect ively collected and stored . Patients with BMI < 35 kg/m2 were compared with those of BMI > 35 kg/m2 . Successful treatment of T2DM was defined by HbA1C < 7.0 % , LDL < 100 mg/dl , and triglyceride < 150 mg/dl . Results Among the 201 patients , 44 ( 21.9 % ) had BMI < 35 kg/m2 , and 114 ( 56.7 % ) had BMI between 35 and 45 , 43 ( 21.4 % ) had BMI > 45 kg/m2 . Patients with BMI < 35 kg/m2 are significantly older , female predominant , had lower liver enzyme and C-peptide levels than those with BMI > 35 kg/m2 . The mean total weight loss for the population was 32.1 , 33.4 , 31.9 , and 32.8 % ( at 1 , 2 , 3 , 5 years after surgery ) , and percentage to change in BMI was 31.9 , 34.2 , 32.2 , and 29.5 % at 1 , 2 , 3 , and 5 years . One year after surgery , fasting plasma glucose returned to normal in 89.5 % of BMI < 35 kg/m2 T2DM and 98.5 % of BMI > 35 kg/m2 patients ( p = 0.087 ) . The treatment goal of T2DM ( HbA1C < 7.0 % , LDL < 150 mg/dl and triglyceride < 150 mg/dl ) was met in 76.5 % of BMI < 35 kg/m2 and 92.4 % of BMI > 350 kg/m2 ( p = 0.059 ) . Conclusion Laparoscopic gastric bypass result ed in significant and sustained weight loss with successful treatment of T2DM up to 87.1 % . Despite a slightly lower response rate of T2DM treatment , patients with BMI < 35 still had an acceptable DM resolution , and this treatment option can be offered to this group of patients 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 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 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 ( RYGB ) benefits patients with type 2 diabetes mellitus ( T2DM ) and a body mass index ( BMI ) > 35 kg/m(2 ) ; however , its effectiveness in patients with T2DM and a BMI < 35 kg/m(2 ) is unclear . Asian Indians have a high risk of T2DM and cardiovascular disease at relatively low BMI levels . We examined the safety and efficacy of RYGB in Asian Indian patients with T2DM and a BMI of 22 - 35 kg/m(2 ) in a tertiary care medical center . METHODS A total of 15 consecutive patients with T2DM and a BMI of 22 - 35 kg/m(2 ) underwent RYGB .  The data were prospect ively collected before surgery and at 1 , 3 , 6 , and 9 months postoperatively . RESULTS Of the 15 patients , 8 were men and 7 were women ( age 45.6 + /- 12 years ) . Their preoperative characteristics were BMI 28.9 + /- 4.0 kg/m(2 ) , body weight 78.7 + /- 12.5 kg , waist circumference 100.2 + /- 6.8 cm , and duration of T2DM 8.7 + /- 5.3 years . At baseline , 80 % of subjects required insulin , and 20 % controlled their T2DM with oral hypoglycemic medication . The BMI decreased postoperatively by 20 % , from 28.9 + /- 4.0 kg/m(2 ) to 23.0 + /- 3.6 kg/m(2 ) ( P < .001 ) . All antidiabetic medications were discontinued by 1 month after surgery in 80 % of the subjects . At 3 months and thereafter , 100 % were euglycemic and no longer required diabetes medication . The fasting blood glucose level decreased from 233 + /- 87 mg/dL to 89 + /- 12 mg/dL ( P < .001 ) , and the hemoglobin A1c decreased from 10.1 % + /- 2.0 % to 6.1 % + /- 0.6 % ( P < .001 ) . Their waist circumference , presence of dyslipidemia , and hypertension improved significantly . The predicted 10-year cardiovascular disease risk ( calculated using the United Kingdom Prospect i ve Diabetes Study equations ) decreased substantially for fatal and nonfatal coronary heart disease and stroke . No mortality , major surgical morbidity , or excessive weight loss occurred . CONCLUSION RYGB safely and effectively eliminated T2DM in Asian Indians with a BMI < 35 kg/m(2 ) . Larger , longer term studies are needed to confirm this benefit 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 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 Background Most morbidly obese patients who undergo gastric bypass  experience rapid remission of type 2 diabetes mellitus ( T2DM ) but the response in non-morbidly obese patients is not clear . This trial prospect ively assessed the effect of diabetes remission , glucose metabolism , and the serial changes of insulin secretion after gastric bypass in inadequately controlled T2DM patients with a BMI of 23–35 kg/m2 . Methods A total of 62 consecutive patients with T2DM and a BMI of 23–35 kg/m2 underwent gastric bypass .  Data were prospect ively collected before surgery and 1 , 4 , 12 , 26 , and 52 weeks and 2 years after surgery . Insulin secretion was measured by insulinogenic index and area under the curve ( AUC ) during a st and ard oral glucose tolerance test ( OGTT ) . Remission of type 2 diabetes was defined as fasting glucose level < 110 mg/dl and HbA1c < 6.0 % without any glycemic therapy . Results Of the 62 patients , 24 were men and 38 were women ( age 43.1 ± 10.8 years ) . Their preoperative characteristics were as follows : BMI 30.1 ± 3.3 kg/m2 , waist circumference 99.6 ± 9.6 cm , C-peptide 3.1 ± 1.4 ng/ml , and duration of T2DM 5.4 ± 5.1 years . The mean BMI decreased postoperatively to 22.6 ± 2.3 kg/m2 in 1 year and 23.0 ± 2.7 kg/m2 in 2 years . The mean HbA1c decreased from 9.7 ± 1.9 % to 5.8 ± 0.5 % in 1 year and 5.9 ± 0.5 % in 2 years . Complete remission of T2DM was achieved in 57 % in 1 year and 55 % in 2 years after surgery . Before surgery , the OGTT test showed a blunted insulin secretion pattern with an insulinogenic index of 0.1 ± 0.2 and AUC of 2,324 ± 1,015 μIU min/ml . In 1 week after surgery , the insulinogenic index increased to 0.16 and AUC decreased to 1,366 μIU min/ml along with a rapid drop of insulin resistance . The insulinogenic index and AUC gradually increased to 0.27 and 3,220 , respectively , 1 year after surgery and remained stable up to 2 years with a very low insulin resistance . Conclusions Laparoscopic gastric bypass facilitates immediate improvement in the glucose metabolism of inadequately controlled non-severe  obese T2DM patients , and the benefit is sustained up to 2 years after surgery . The benefit is regulated by the decrease in insulin resistance , increase in early insulin response , and total insulin secretion to glucose load Type 2 diabetes ( T2D ) remission after bariatric procedures has been highlighted in many retrospective and some recent prospect i ve studies . However , in the most recent prospect i ve study , more than 50 % of patients did not reach T2D remission at 1 year . Our aim was to identify baseline positive predictors for T2D remission at 1 year after bariatric surgery and to build a preoperative predictive score . We analysed the data concerning 161 obese operated on between June 2007 and December 2010 . Among them , 46 were diabetic and were included in the study —11 laparoscopic adjustable gastric b and ing ( LAGB ) , 26 Roux-en-Y gastric bypass ( RYGB ) and 9 sleeve gastrectomy ( SG ) .  We compared anthropometric and metabolic features during 1 year of follow-up . A receiver operating characteristic analysis was performed to predict T2D remission . RYGB and SG were similarly efficient for body weight loss and more efficient than LAGB ; 62.8 % of patients presented with T2DM remission at 1 year , with no significant difference according to the surgical procedure . A 1-year body mass index ( BMI ) < 35 kg m−2 was predictive of T2DM remission whatever the procedure . The preoperative predictive factors of diabetes remission were baseline BMI ≤50 kg m−2 , duration of type 2 diabetes ≤4 years , glycated haemoglobin ≤7.1 % , fasting glucose < 1.14 g/l and absence of insulin therapy . A short duration of diabetes and good preoperative glycaemic control increase the rate of T2DM remission 1 year after surgery . Preoperative metabolic data could be of greater importance than the choice of bariatric procedure 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 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 OBJECTIVE To prospect ively examine the effect of weight loss 1 year after  laparoscopic adjustable gastric b and surgery on a broad range of health outcomes in 50 diabetic subjects . RESEARCH DESIGN AND METHODS A total of 50 ( 17 men , 33 women ) of 51 patients with type 2 diabetes , from a total of 500 consecutive patients , were studied preoperatively and again 1 year after surgery . RESULTS Preoperative weight and BMI ( means + /- SD ) were 137 + /- 30 kg and 48.2 + /- 8 kg/m(2 ) , respectively ; at 1 year , weight and BMI were 110 + /- 24 kg and 38.7 + /- 6 kg/m(2 ) , respectively . There was significant improvement in all measures of glucose metabolism . Remission of diabetes occurred in 32 patients ( 64 % ) , and major improvement of glucose control occurred in 13 patients ( 26 % ) ; glucose metabolism was unchanged in 5 patients ( 10 % ) . HbA(1c ) was 7.8 + /- 3.2 % preoperatively and 6.2 + /- 2.7 % at 1 year ( P < 0.001 ) . Remission of diabetes was predicted by greater weight loss and a shorter history of diabetes ( pseudo r(2 ) = 0.44 , P < 0.001 ) . Improvement in diabetes was related to increased insulin sensitivity and beta-cell function . Weight loss was associated with significant improvements in fasting triglyceride level , HDL cholesterol level , hypertension , sleep , depression , appearance evaluation , and health-related quality of life . Early complications occurred in 6 % of patients ( wound infections in 4 % , respiratory support in 2 % ) , and late complications occurred in 30 % of patients ( gastric prolapse in 20 % , b and erosion in 6 % , and tubing leaks in 4 % ) . All late complications were successfully revised surgically . CONCLUSIONS Modern laparoscopic weight-loss surgery is effective in managing the broad range of health problems experienced by severely obese individuals with type 2 diabetes . Surgery should be considered as an early intervention CONTEXT Observational studies suggest that surgically induced loss of weight may be effective therapy for type 2 diabetes . OBJECTIVE To determine if surgically induced weight loss results in better glycemic control and less need for diabetes medications than conventional approaches to weight loss and diabetes control . DESIGN , SETTING , AND PARTICIPANTS Unblinded r and omized controlled trial conducted from December 2002 through December 2006 at the University Obesity Research Center in Australia , with general community recruitment to established treatment programs . Participants were 60 obese patients ( BMI > 30 and < 40 ) with recently diagnosed ( < 2 years ) type 2 diabetes . INTERVENTIONS Conventional diabetes therapy with a focus on weight loss by lifestyle change vs laparoscopic adjustable gastric b and ing with conventional diabetes care . MAIN OUTCOME MEASURES Remission of type 2 diabetes ( fasting glucose level < 126 mg/dL [ 7.0 mmol/L ] and glycated hemoglobin [ HbA1c ] value < 6.2 % while taking no glycemic therapy ) . Secondary measures included weight and components of the metabolic syndrome . Analysis was by intention-to-treat . RESULTS Of the 60 patients enrolled , 55 ( 92 % ) completed the 2-year follow-up . Remission of type 2 diabetes was achieved by 22 ( 73 % ) in the surgical group and 4 ( 13 % ) in the conventional-therapy group . Relative risk of remission for the surgical group was 5.5 ( 95 % confidence interval , 2.2 - 14.0 ) . Surgical and conventional-therapy groups lost a mean ( SD ) of 20.7 % ( 8.6 % ) and 1.7 % ( 5.2 % ) of weight , respectively , at 2 years ( P < .001 ) . Remission of type 2 diabetes was related to weight loss ( R2 = 0.46 , P < .001 ) and lower baseline HbA1c levels ( combined R2 = 0.52 , P < .001 ) . There were no serious complications in either group . CONCLUSIONS Participants r and omized to surgical therapy were more likely to achieve remission of type 2 diabetes through greater weight loss . These results need to be confirmed in a larger , more diverse population and have long-term efficacy assessed . TRIAL REGISTRATION actr.org Identifier : ACTRN012605000159651 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 OBJECTIVES To determine the efficacies of 2 weight-reducing operations on diabetic control and the role of duodenum exclusion . DESIGN Double-blind r and omized controlled trial . SETTING Department of Surgery of the Min-Sheng General Hospital , National Taiwan University . PATIENTS We studied 60 moderately obese patients ( body mass index > 25 and < 35 ) aged > 30 to < 60 years who had poorly controlled type 2 diabetes mellitus ( T2DM ) ( hemoglobin A(1c ) [ HbA(1c ) ] > 7.5 % ) after conventional treatment ( > 6 months ) from September 1 , 2007 , through June 30 , 2008 . Patients and observers were masked during the follow-up , which ended in 2009 , 1 year after final enrollment . INTERVENTIONS Gastric bypass with duodenum exclusion ( n = 30 ) vs sleeve gastrectomy without duodenum exclusion ( n = 30 ) . MAIN OUTCOME MEASURES The primary outcome was remission of T2DM ( fasting glucose < 126 mg/dL and HbA(1c ) < 6.5 % without glycemic therapy ) . Secondary measures included weight and metabolic syndrome . Analysis was by intention to treat . RESULTS Of the 60 patients enrolled , all completed the 12-month follow-up . Remission of T2DM was achieved by 28 ( 93 % ) in the gastric bypass group and 14 ( 47 % ) in the sleeve gastrectomy group ( P = .02 ) . Participants assigned to gastric bypass had lost more weight , achieved a lower waist circumference , and had lower glucose , HbA(1c ) , and blood lipid levels than the sleeve gastrectomy group . No serious complications occurred in either group . CONCLUSIONS Participants r and omized to gastric bypass were more likely to achieve remission of T2DM . Duodenum exclusion plays a role in T2DM treatment and should be assessed . Trial Registration clinical trials.gov Identifier : NCT00540462 ( http://www . clinical trials.gov ) 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
Metabolic surgery is superior to medical treatment for short-term remission of T2DM and comorbidities .
OBJECTIVE To compare surgical versus medical treatment  of  type 2 diabetes mellitus ( T2DM ) remission and comorbidities in patients with a body mass index ( BMI ) less than 35 kg/m2 .
BACKGROUND Obesity surgery can achieve remission of T2DM and its comorbidities .
Metabolic surgery has been proposed as a treatment option for diabetic patients with BMI less than 35 kg/m2 but the efficacy of metabolic surgery has not been conclusively determined .