title: Anemia and the Need for Intravenous Iron Infusion after Roux-en-Y Gastric Bypass Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial. Micronutrient and Protein Deficiencies After Gastric Bypass and Sleeve Gastrectomy: a 1-year Follow-up Reduction in Weight and Cardiovascular Disease Risk Factors in Individuals With Type 2 Diabetes 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. Roux-en-Y Gastric Bypass and Vertical Banded Gastroplasty Induce Long-Term Changes on the Human Gut Microbiome Contributing to Fat Mass Regulation Early Results of the Swiss Multicentre Bypass or Sleeve Study (SM-BOSS) Effect of laparoscopic Roux-en-Y gastric bypass surgery on type 2 diabetes mellitus with hypertension: a randomized controlled trial. Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. First Report from the American College of Surgeons Bariatric Surgery Center Network: Laparoscopic Sleeve Gastrectomy has Morbidity and Effectiveness Positioned Between the Band and the Bypass Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial. Bariatric surgery versus intensive medical therapy for diabetes--3-year outcomes. Roux-en-Y gastric bypass for diabetes (the Diabetes Surgery Study): 2-year outcomes of a 5-year, randomised, controlled trial.
abstract: The frequency of anemia , iron deficiency , and the long-term need for IV iron  following Roux-en-y gastric bypass ( RYGB ) surgery  has not been well characterized . Three-hundred and nineteen out of 904 consecutive subjects who underwent RYGB at Penn State Hershey Medical Center from 1999 to 2006 met the inclusion criteria for a preoperative complete blood count ( CBC ) and at least one CBC > 6 months following surgery . Cumulative incidence of anemia 7 years post procedure was 58 % . Menstruation status and presence of preoperative anemia were predictive of anemia by univariate analysis and multivariable Cox regression ( P= 0.0014 and 0.044 , respectively ) . Twenty-seven subjects , primarily premenopausal women , representing 8.5 % of the cohort and 22 % of the 122 anemic subjects , needed intravenous ( IV ) iron  a mean of 51 months postoperatively for anemia unresponsive or refractory to oral iron . The risk for development of anemia necessitating IV iron therapy following RYGB is highest in menstruating women and continues to increase for many years , even in post-menopausal women . Well- design ed prospect i ve studies are needed to identify the incidence of iron deficiency anemia and the patient population s at increased risk for requiring IV iron replacement after RYGB surgery IMPORTANCE Controlling glycemia , blood pressure , and cholesterol is important for patients with diabetes . How best to achieve this goal is unknown . OBJECTIVE To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors . DESIGN , SETTING , AND PARTICIPANTS A 12-month , 2-group unblinded r and omized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c ( HbA1c ) level of 8.0 % or higher , body mass index ( BMI ) between 30.0 and 39.9 , C peptide level of more than 1.0 ng/mL , and type 2 diabetes for at least 6 months . The study began in April 2008 . INTERVENTIONS Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery . Medications for hyperglycemia , hypertension , and dyslipidemia were prescribed according to protocol and surgical techniques that were st and ardized . MAIN OUTCOMES AND MEASURES Composite goal of HbA1c less than 7.0 % , low-density lipoprotein cholesterol less than 100 mg/dL , and systolic blood pressure less than 130 mm Hg . RESULTS All 120 patients received the intensive lifestyle-medical management protocol and 60 were r and omly assigned to undergo Roux-en-Y gastric bypass . After 12-months , 28 participants ( 49 % ; 95 % CI , 36%-63 % ) in the gastric bypass group and 11 ( 19 % ; 95 % CI , 10%-32 % ) in the lifestyle-medical management group achieved the primary end points ( odds ratio [ OR ] , 4.8 ; 95 % CI , 1.9 - 11.7 ) . Participants in the gastric bypass group required 3.0 fewer medications ( mean , 1.7 vs 4.8 ; 95 % CI for the difference , 2.3 - 3.6 ) and lost 26.1 % vs 7.9 % of their initial body weigh compared with the lifestyle-medical management group ( difference , 17.5 % ; 95 % CI , 14.2%-20.7 % ) . Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss . There were 22 serious adverse events in the gastric bypass group , including 1 cardiovascular event , and 15 in the lifestyle-medical management group . There were 4 perioperative complications and 6 late postoperative complications . The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group . CONCLUSIONS AND RELEVANCE In mild to moderately obese patients with type 2 diabetes , adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal . Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00641251 Background Roux-en-Y gastric bypass ( GBP ) and sleeve gastrectomy ( SG ) have increased dramatically , potentially increasing the prevalence of nutritional deficiencies . The aim of this study was to analyze the effects of food restriction during the first year after  bariatric surgery ( BS ) on nutritional parameters . Methods Twenty-two and 30 obese patients undergoing GBP and SG  were prospect ively followed at baseline and 3 , 6 , and 12 months after BS ( N = 14 and N = 19 at T12 ) . We evaluated food intake and nutrient adequacy ( T0 , T3 , T12 ) , as well as serum vitamin and mineral concentration ( T0 , T3 , T6 , T12 ) . Results At baseline , GBP and SG patients had similar clinical characteristics , food intake , nutrient adequacy , and serum concentration . The drastic energy and food reduction led to very low probabilities of adequacy for nutrients similar in both models ( T3 , T12 ) . Serum analysis demonstrated a continuous decrease in prealbumin during the follow-up , indicating mild protein depletion in 37 and 38 % of GBP patients and 57 and 52 % of SG patients , respectively , at T3 and T12 . Conversely , despite the low probabilities of adequacy observed at T3 and T12 , systematic multivitamin and mineral supplementation after GBP and SG prevented most nutritional deficiencies . Conclusions GBP and SG have comparable effects in terms of energy and food restriction and subsequent risk of micronutrient and protein deficiencies in the first year post BS . Such results advocate for a cautious monitoring of protein intake after GPB and SG and a systematic multivitamin and mineral supplementation in the first year after SG OBJECTIVE —The effectiveness of intentional weight loss in reducing cardiovascular disease ( CVD ) events in type 2 diabetes is unknown . This report describes 1-year changes in CVD risk factors in a trial design ed to examine the long-term effects of an intensive lifestyle intervention on the incidence of major CVD events . RESEARCH DESIGN AND METHODS —This study consisted of a multicentered , r and omized , controlled trial of 5,145 individuals with type 2 diabetes , aged 45–74 years , with BMI > 25 kg/m2 ( > 27 kg/m2 if taking insulin ) . An intensive lifestyle intervention ( ILI ) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared with a diabetes support and education ( DSE ) condition . RESULTS — Participants assigned to ILI lost an average 8.6 % of their initial weight vs. 0.7 % in DSE group ( P < 0.001 ) . Mean fitness increased in ILI by 20.9 vs. 5.8 % in DSE ( P < 0.001 ) . A greater proportion of ILI participants had reductions in diabetes , hypertension , and lipid-lowering medicines . Mean A1C dropped from 7.3 to 6.6 % in ILI ( P < 0.001 ) vs. from 7.3 to 7.2 % in DSE . Systolic and diastolic pressure , triglycerides , HDL cholesterol , and urine albumin-to-creatinine ratio improved significantly more in ILI than DSE participants ( all P < 0.01 ) . CONCLUSIONS —At 1 year , ILI result ed in clinical ly significant weight loss in people with type 2 diabetes . This was associated with improved diabetes control and CVD risk factors and reduced medicine use in ILI versus DSE . Continued intervention and follow-up will determine whether these changes are maintained and will reduce CVD risk 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 Summary Bariatric surgery is currently the most effective procedure for the treatment of obesity . Given the role of the gut microbiota in regulating host metabolism and adiposity , we investigated the long-term effects of bariatric surgery on the microbiome of patients r and omized to Roux-en-Y gastric bypass or vertical b and ed gastroplasty and matched for weight and fat mass loss . The two surgical procedures induced similar and durable changes on the gut microbiome that were not dependent on body mass index and result ed in altered levels of fecal and circulating metabolites compared with obese controls . By colonizing germ-free mice with stools from the patients , we demonstrated that the surgically altered microbiota promoted reduced fat deposition in recipient mice . These mice also had a lower respiratory quotient , indicating decreased utilization of carbohydrates as fuel . Our results suggest that the gut microbiota may play a direct role in the reduction of adiposity observed after bariatric surgery Objective : Laparoscopic sleeve gastrectomy ( LSG ) has been proposed as an effective alternative to the current st and ard procedure , laparoscopic Roux-en-Y gastric bypass ( LRYGB ) . Prospect i ve data comparing both procedures are rare . Therefore , we performed a r and omized clinical trial assessing the effectiveness and safety of these 2 operative techniques . Methods : Two hundred seventeen patients were r and omized at 4 bariatric centers in Switzerl and . One hundred seven patients underwent LSG using a 35-F bougie with suturing of the stapler line , and 110 patients underwent LRYGB with a 150-cm antecolic alimentary and a 50-cm biliopancreatic limb . The mean body mass index of all patients was 44 ± 11.1 kg/m2 , the mean age was 43 ± 5.3 years , and 72 % were female . Results : The 2 groups were similar in terms of body mass index , age , sex , comorbidities , and eating behavior . The mean operative time was less for LSG than for LRYGB ( 87 ± 52.3 minutes vs 108 ± 42.3 minutes ; P = 0.003 ) . The conversion rate was 0.9 % in both groups . Complications ( < 30 days ) occurred more often in LRYGB than in LSG ( 17.2 % vs 8.4 % ; P = 0.067 ) . However , the difference in severe complications did not reach statistical significance ( 4.5 % for LRYGB vs 1 % for LSG ; P = 0.21 ) . Excessive body mass index loss 1 year after the operation was similar between the 2 groups ( 72.3 % ± 22 % for LSG and 76.6 % ± 21 % for LRYGB ; P = 0.2 ) . Except for gastroesophageal reflux disease , which showed a higher resolution rate after LRYGB , the comorbidities and quality of life were significantly improved after both procedures . Conclusions : LSG was associated with shorter operation time and a trend toward fewer complications than with LRYGB . Both procedures were almost equally efficient regarding weight loss , improvement of comorbidities , and quality of life 1 year after surgery . Long-term follow-up data are needed to confirm these facts 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 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 Weight loss is associated with short-term amelioration and prevention of metabolic and cardiovascular risk , but whether these benefits persist over time is unknown . METHODS The prospect i ve , controlled Swedish Obese Subjects Study involved obese subjects who underwent gastric surgery and contemporaneously matched , conventionally treated obese control subjects . We now report follow-up data for subjects ( mean age , 48 years ; mean body-mass index , 41 ) who had been enrolled for at least 2 years ( 4047 subjects ) or 10 years ( 1703 subjects ) before the analysis ( January 1 , 2004 ) . The follow-up rate for laboratory examinations was 86.6 percent at 2 years and 74.5 percent at 10 years . RESULTS After two years , the weight had increased by 0.1 percent in the control group and had decreased by 23.4 percent in the surgery group ( P<0.001 ) . After 10 years , the weight had increased by 1.6 percent and decreased by 16.1 percent , respectively ( P<0.001 ) . Energy intake was lower and the proportion of physically active subjects higher in the surgery group than in the control group throughout the observation period . Two- and 10-year rates of recovery from diabetes , hypertriglyceridemia , low levels of high-density lipoprotein cholesterol , hypertension , and hyperuricemia were more favorable in the surgery group than in the control group , whereas recovery from hypercholesterolemia did not differ between the groups . The surgery group had lower 2- and 10-year incidence rates of diabetes , hypertriglyceridemia , and hyperuricemia than the control group ; differences between the groups in the incidence of hypercholesterolemia and hypertension were undetectable . CONCLUSIONS As compared with conventional therapy , bariatric surgery appears to be a viable option for the treatment of severe obesity , result ing in long-term weight loss , improved lifestyle , and , except for hypercholesterolemia , amelioration in risk factors that were elevated at baseline Objective : To assess the safety and effectiveness of the laparoscopic sleeve gastrectomy ( LSG )  as compared to the laparoscopic adjustable gastric b and ( LAGB ) , the laparoscopic Roux-en-Y gastric bypass ( LRYGB ) and the open Roux-en-Y gastric bypass ( ORYGB ) for the treatment of obesity and obesity-related diseases . Background : LSG is a newer procedure being done with increasing frequency . However , limited data are currently available comparing LSG to the other established procedures . We present the first prospect i ve , multiinstitutional , nationwide , clinical ly rich , bariatric-specific data comparing  sleeve gastrectomy to the adjustable gastric b and , and the gastric bypass . Methods : This is the initial report analyzing data from the American College of Surgeons — Bariatric Surgery Center Network accreditation program , and its prospect i ve , longitudinal , data collection system based on st and ardized definitions and collected by trained data review ers . Univariate and multivariate analyses compare 30-day , 6-month , and 1-year outcomes including morbidity and mortality , readmissions , and reoperations as well as reduction in body mass index ( BMI ) and weight-related comorbidities . Results : One hundred nine hospitals su bmi tted data for 28,616 patients , from July , 2007 to September , 2010 . The LSG has higher risk-adjusted morbidity , readmission and reoperation/intervention rates compared to the LAGB , but lower reoperation/intervention rates compared to the LRYGB and ORYGB . There were no differences in mortality . Reduction in BMI and most of the weight-related comorbidities after the LSG also lies between those of the LAGB and the LRYGB/ORYGB . Conclusion : LSG has morbidity and effectiveness positioned between the LAGB and the LRYGB/ORYGB for data up to 1 year . As obesity is a lifelong disease , longer term comparative effectiveness data are most critical , and are yet to be determined 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 In short-term r and omized trials ( duration , 1 to 2 years ) , bariatric surgery has been associated with improvement in type 2 diabetes mellitus . METHODS We assessed outcomes 3 years after the r and omization of 150 obese patients with uncontrolled type 2 diabetes to receive either intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy .  The primary end point was a glycated hemoglobin level of 6.0 % or less . RESULTS The mean ( ±SD ) age of the patients at baseline was 48±8 years , 68 % were women , the mean baseline glycated hemoglobin level was 9.3±1.5 % , and the mean baseline body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 36.0±3.5 . A total of 91 % of the patients completed 36 months of follow-up . At 3 years , the criterion for the primary end point was met by 5 % of the patients in the medical-therapy group , as compared with 38 % of those in the gastric-bypass group ( P<0.001 ) and 24 % of those in the sleeve-gastrectomy group ( P=0.01 ) . The use of glucose-lowering medications , including insulin , was lower in the surgical groups than in the medical-therapy group . Patients in the surgical groups had greater mean percentage reductions in weight from baseline , with reductions of 24.5±9.1 % in the gastric-bypass group and 21.1±8.9 % in the sleeve-gastrectomy group , as compared with a reduction of 4.2±8.3 % in the medical-therapy group ( P<0.001 for both comparisons ) . Quality -of-life measures were significantly better in the two surgical groups than in the medical-therapy group . There were no major late surgical complications . CONCLUSIONS Among obese patients with uncontrolled type 2 diabetes , 3 years of intensive medical therapy plus bariatric surgery result ed in glycemic control in significantly more patients than did medical therapy alone . Analyses of secondary end points , including body weight , use of glucose-lowering medications , and quality of life , also showed favorable results at 3 years in the surgical groups , as compared with the group receiving medical therapy alone . ( Funded by Ethicon and others ; STAMPEDE Clinical Trials.gov number , NCT00432809 . ) BACKGROUND Conventional treatments for patients with type 2 diabetes are often inadequate . We aim ed to assess outcomes of diabetes control and treatment risks 2 years after adding Roux-en-Y gastric bypass to intensive lifestyle and medical management . METHODS We report 2-year outcomes of a 5-year r and omised trial ( the Diabetes Surgery Study ) at four teaching hospitals ( three in the USA and one in Taiwan ) . At baseline , eligible participants had to have HbA1c of at least 8·0 % ( 64 mmol/mol ) , BMI between 30·0 and 39·9 kg/m(2 ) , and type 2 diabetes for at least 6 months , and be aged 30 - 67 years . We r and omly assigned participants to receive either intensive lifestyle and medical management alone ( lifestyle and medical management ) , or lifestyle and medical management plus st and ard Roux-en-Y gastric bypass surgery ( gastric bypass ) . Staff from the clinical centres had access to data from individual patients , but were masked to other patients ' data and aggregated data until the 2-year follow-up . Drugs for hyperglycaemia , hypertension , and dyslipidaemia were prescribed by protocol . The primary endpoint was achievement of the composite treatment goal of HbA1c less than 7·0 % ( 53 mmol/mol ) , LDL cholesterol less than 2·59 mmol/L , and systolic blood pressure less than 130 mm Hg at 12 months ; here we report the composite outcome and other pre-planned secondary outcomes at 24 months . Analyses were done on an intention-to-treat basis , with multiple imputations for missing data . This study is registered with Clinical Trials.gov , number NCT00641251 , and is still ongoing . FINDINGS Between April 21 , 2008 , and Nov 21 , 2011 , we r and omly assigned 120 eligible patients to either lifestyle and medical management alone ( n=60 ) or with the addition of gastric bypass ( n=60 ) . One patient in the lifestyle and medical management group died ( from pancreatic cancer ) , thus 119 were included in the primary analysis . Significantly more participants in the gastric bypass group achieved the composite triple endpoint at 24 months than in the lifestyle and medical management group ( 26 [ 43 % ] vs eight [ 14 % ] ; odds ratio 5·1 [ 95 % CI 2·0 - 12·6 ] , p=0·0004 ) , mainly through improved glycaemic control ( HbA1c < 7·0 % [ 53 mmol/mol ] in 45 [ 75 % ] vs 14 [ 24 % ] ; treatment difference -1·9 % ( -2·5 to -1·4 ) ; p=0·0001 ) . 46 clinical ly important adverse events occurred in the gastric bypass group and 25 in the lifestyle and medical management group ( mainly infections in both groups [ four in the lifestyle and medical management group , eight in the gastric bypass group ] ) . With a negative binomial model adjusted for site , the event rate for the gastric bypass group was non-significantly higher than the lifestyle and medical management group by a factor of 1·67 ( 95 % CI 0·98 - 2·87 , p=0·06 ) . Across both years of the study , the gastric bypass group had seven serious falls with five fractures , compared with three serious falls and one fracture in the lifestyle and medical management group . All fractures happened in women . Many more nutritional deficiencies occurred in the gastric bypass group ( mainly deficiencies in iron , albumin , calcium , and vitamin D ) , despite protocol use of nutritional supplements . INTERPRETATION The addition of gastric bypass to lifestyle and medical management in patients with type 2 diabetes improved diabetes control , but adverse events and nutritional deficiencies were more frequent . Larger and longer studies are needed to investigate whether the benefits and risk of gastric bypass for type 2 diabetes can be balanced . FUNDING Covidien , National Institutes of Health , National Institute of Diabetes and Digestive and Kidney Diseases Nutrition Obesity Research Centers , and the National Center for Advancing Translational Sciences
target: 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 .
background: 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 .