title: Preserved Insulin Secretory Capacity and Weight Loss Are the Predominant Predictors of Glycemic Control in Patients With Type 2 Diabetes Randomized to Roux-en-Y Gastric Bypass 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 Surgical vs conventional therapy for weight loss treatment of obstructive sleep apnea: a randomized controlled trial. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. Improved acylated ghrelin suppression at 2 years in obese patients with type 2 diabetes: effects of bariatric surgery vs standard medical therapy An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study—A Two-Year Randomized Controlled Clinical Trial Who Would Have Thought It? An Operation Proves to Be the Most Effective Therapy for Adult‐Onset Diabetes Mellitus Erectile dysfunction and hormonal imbalance in morbidly obese male is reversed after gastric bypass surgery: a prospective randomized controlled trial. Intensive Medical Weight Loss or Laparoscopic Adjustable Gastric Banding in the Treatment of Mild to Moderate Obesity: Long-Term Follow-up of a Prospective Randomised Trial Effect of laparoscopic Roux-en-Y gastric bypass surgery on type 2 diabetes mellitus with hypertension: a randomized controlled trial. Sex hormone-binding globulin levels and cardiovascular risk factors in morbidly obese subjects before and after weight reduction induced by diet or malabsorptive surgery. Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. Multidisciplinary diabetes care with and without bariatric surgery in overweight people: a randomised controlled trial. Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial. Laparoscopic adjustable gastric banding in severely obese adolescents: a randomized trial. Bariatric surgery versus intensive medical therapy for diabetes--3-year outcomes. Two-year outcomes on bone density and fracture incidence in patients with T2DM randomized to bariatric surgery versus intensive medical therapy. Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial.
abstract: Improvement in  type 2 diabetes after Roux-en-Y gastric bypass ( RYGB )  has been attributed partly to weight loss , but mechanisms beyond weight loss remain unclear . We performed an ancillary study to the Diabetes Surgery Study to assess changes in incretins , insulin sensitivity , and secretion 1 year after r and omization to lifestyle modification and intensive medical management ( LS/IMM ) alone  ( n = 34 ) or in conjunction with RYGB  ( n = 34 ) . The RYGB group lost more weight and had greater improvement in HbA1c . Fasting glucose was lower after RYGB than after LS/IMM , although the glucose area under the curve decreased comparably for both groups . Insulin sensitivity increased in both groups . Insulin secretion was unchanged after LS/IMM but decreased after RYGB , except for a rapid increase during the first 30 min after meal ingestion . Glucagon-like peptide 1 ( GLP-1 ) was substantially increased after RYGB , while gastric inhibitory polypeptide and glucagon decreased . Lower HbA1c was most strongly correlated with the percentage of weight loss for both groups . At baseline , a greater C-peptide index and 90-min postpr and ial C-peptide level were predictive of lower HbA1c at 1 year after RYGB . β-Cell glucose sensitivity , which improved only after RYGB , and improved disposition index were associated with lower HbA1c in both groups , independent of weight loss . Weight loss and preserved β-cell function both predominantly determine the greatest glycemic benefit after RYGB 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 : CONTEXT Obstructive sleep apnea ( OSA ) is strongly related to obesity . Weight loss is recommended as part of the overall management plan for obese patients diagnosed with OSA . OBJECTIVE To determine whether surgically induced weight loss is more effective than conventional weight loss therapy in the management of OSA . DESIGN , SETTING , AND PATIENTS A r and omized controlled trial of 60 obese patients ( body mass index : > 35 and < 55 ) with recently diagnosed ( < 6 months ) OSA and an apnea-hypopnea index ( AHI ) of 20 events/hour or more . These patients had been prescribed continuous positive airway pressure ( CPAP )  therapy to manage OSA and were identified via accredited community sleep clinics . The trial was conducted between September 2006 and March 2009 by university- and teaching hospital-based clinical research ers in Melbourne , Australia . Patients with obesity hypoventilation syndrome , previous bariatric surgery , contraindications to bariatric surgery , or significant cardiopulmonary , neurological , vascular , gastrointestinal , or neoplastic disease were excluded . INTERVENTIONS Patients were r and omized to a conventional weight loss program that included regular consultations with a dietitian and physician , and the use of very low-calorie diets as necessary ( n = 30 ) or to bariatric surgery ( laparoscopic adjustable gastric b and ing ; n = 30 ) . MAIN OUTCOME MEASURES The primary outcome was baseline to 2-year change in AHI on diagnostic polysomnography scored by staff blinded to r and omization . Secondary outcomes were changes in weight , CPAP adherence , and functional status . RESULTS Patients lost a mean of 5.1 kg ( 95 % CI , 0.8 to 9.3 kg ) in the conventional weight loss program compared with 27.8 kg ( 95 % CI , 20.9 to 34.7 kg ) in the bariatric surgery group ( P < .001 ) . The AHI decreased by 14.0 events/hour ( 95 % CI , 3.3 to 24.6 events/hour ) in the conventional weight loss group and by 25.5 events/hour ( 95 % CI , 14.2 to 36.7 events/hour ) in the bariatric surgery group . The between-group difference was -11.5 events/hour ( 95 % CI , -28.3 to 5.3 events/hour ; P = .18 ) . CPAP adherence did not differ between the groups . The bariatric surgery group had greater improvement in the Short Form 36 physical component summary score ( mean , 9.3 [ 95 % CI , 0.5 to 18.0 ] ; P = .04 ) . CONCLUSION Among a group of obese patients with OSA , the use of bariatric surgery compared with conventional weight loss therapy did not result in a statistically greater reduction in AHI despite major differences in weight loss . TRIAL REGISTRATION anzctr.org Identifier : 12605000161628 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 Objective : Roux-en-Y gastric bypass ( RYGB ) produces more durable glycemic control than sleeve gastrectomy ( SG ) or intensive medical therapy ( IMT ) . However , the contribution of acylated ghrelin ( AG ) , a gluco-regulatory/appetite hormone , to improve glucose metabolism and body composition in patients with type 2 diabetes ( T2D ) following RYGB is unknown . Design : STAMPEDE ( Surgical Treatment and Medication Potentially Eradicate Diabetes Efficiently ) was a prospect i ve , r and omized controlled trial . Subjects : Fifty-three ( body mass index : 36±3 kg m−2 , age : 49±9 years ) poorly controlled patients with T2D ( HbA1c ( glycated hemoglobin ) : 9.7±2 % ) were r and omized to IMT , IMT+RYGB or IMT+SG and underwent a mixed-meal tolerance test at baseline , 12 , and 24 months for evaluation of AG suppression ( postpr and ial minus fasting ) and beta-cell function ( oral disposition index ; glucose-stimulated insulin secretion × Matsuda index ) . Total/ and roid body fat ( dual-energy X-ray absorptiometry ) was also assessed . Results : RYGB and SG reduced body fat comparably ( 15–23 kg ) at 12 and 24 months , whereas IMT had no effect . Beta-cell function increased 5.8-fold in RYGB and was greater than IMT at 24 months ( P<0.001 ) . However , there was no difference in insulin secretion between SG vs IMT at 24 months ( P=0.32 ) . Fasting AG was reduced fourfold following SG ( P<0.01 ) and did not change with RYGB or IMT at 24 months . AG suppression improved more following RYGB than SG or IMT at 24 months ( P=0.01 vs SG , P=0.07 vs IMT ) . At 24 months , AG suppression was associated with increased postpr and ial glucagon-like peptide-1 ( r=−0.32 , P<0.02 ) and decreased and roid fat ( r=0.38 ; P<0.006 ) . Conclusions : Enhanced AG suppression persists for up to 2 years after RYGB , and this effect is associated with decreased and roid obesity and improved insulin secretion . Together , these findings suggest that AG suppression is partly responsible for the improved glucose control after RYGB surgery Bariatric surgery is currently the most effective therapy to induce weight loss in morbidly obese patients . Objective . This controlled , clinical trial with a two-year intervention was aim ed at comparing the efficacy of two nonsurgical approaches versus bariatric surgery , on body weight changes and metabolic parameters in morbidly obese patients . Methods . Patients were r and omized to an Intensive Lifestyle Intervention ( ILI ) ( n = 60 ) or Conventional Obesity Therapy ( COT ) ( n = 46 ) . The ILI group received behavioral therapy and nutritional counseling . The COT group received st and ard medical treatment . They were compared with a third group , Surgical Obesity Group ( SOG ) ( n = 37 ) . Results . Patients who received ILI had a greater percentage of weight loss than patients receiving COT ( −11.3 % versus −1.6 % ; p < 0.0044 ) . Interestingly 31.4 % of patients included in the ILI group were no longer morbidly obese after just six months of intervention , increasing to 44.4 % after 24 months of intervention . The percentage weight loss in SOG was −29.6 % after that same period of time . Conclusions . ILI was associated with significant weight loss when compared to COT , in a group of patients with obesity .  An ILI approach could be an alternative therapy to patients with obesity , who are not c and i date s to undergo bariatric surgery . This trial is registered with EudraCT 2009 - 013737 - 24 Objective This report documents that the gastric bypass operation provides long-term control for obesity and diabetes .  Summary Background Data Obesity and diabetes , both notoriously resistant to medical therapy , continue to be two of our most common and serious diseases . Methods Over the last 14 years , 608 morbidly obese patients underwent gastric bypass  , an operation that restricts caloric intake by ( 1 ) reducing the functional stomach to approximately 30 mL , ( 2 ) delaying gastric emptying with a c. 0.8 to 1.0 cm gastric outlet , and ( 3 ) excluding foregut with a 40 to 60 cm Roux-en-Y gastrojejunostomy . Even though many of the patients were seriously ill , the operation was performed with a perioperative mortality and complication rate of 1.5 % and 8.5 % , respectively . Seventeen of the 608 patients ( <3 % ) were lost to follow-up . Results Gastric bypass provides durable weight control . Weights fell from a preoperative mean of 304.4 lb ( range , 198 to 615 lb ) to 192.2 lb ( range , 104 to 466 ) by 1 year and were maintained at 205.4 lb ( range , 107 to 512 lb ) at 5 years , 206.5 lb ( 130 to 388 lb ) at 10 years , and 204.7 lb ( 158 to 270 lb ) at 14 years . The operation provides long-term control of non-insulin-dependent diabetes mellitus ( NIDDM ) . In those patients with adequate follow-up , 121 of 146 patients ( 82.9 % ) with NIDDM and 150 of 152 patients ( 98.7 % ) with glucose impairment maintained normal levels of plasma glucose , glycosylated hemoglobin , and insulin . These antidiabetic effects appear to be due primarily to a reduction in caloric intake , suggesting that insulin resistance is a secondary protective effect rather than the initial lesion . In addition to the control of weight and NIDDM , gastric bypass also corrected or alleviated a number of other comorbidities of obesity , including hypertension , sleep apnea , cardiopulmonary failure , arthritis , and infertility The effects of weight loss on erectile function and hormones have not been well studied . The aim of this study was to measure the degree to which sexual function and in particular erectile function and hormonal environment change after substantial weight loss , surgically and non-surgically induced in the morbidly obese male in a prospect i ve r and omized long-term controlled trial . Furthermore , how surgery makes a difference when treating morbidly obese men was envisaged in this context . We prospect ively studied 20 morbidly obese men for 24 months , divided into two groups : group  A  included 10 patients who underwent life style modifications ( exercise and diet ) for 4 months and subsequently gastric bypass , and another 10 patients in group B were kept on weekly follow-up . None of the men were taking phosphodiesterase type-5 inhibitors . All patients underwent International Index of Erectile Function (IIEF)-5 question naire , serum oestradiol , prolactin ( PRL ) , luteinizing ( LH ) and follicle-stimulating ( FSH ) hormones , free and total testosterone ( FT and TT ) at baseline ( time 0 ) , surgery - 4 months latter baseline ( time 1 ) and final evaluation - 24 months ( time 2 ) . From times 0 to 1 , group A presented a mean body mass index ( BMI ) reduction of 12.6 ( p < 0.0001 ) , whereas group B , 2.1 ( p > 0.05 ) . The BMI reductions between times 0 and 2 were 24.7 ( p < 0.0001 ) and 0.7 ( p > 0.05 ) for groups A and B respectively . BMI average between the two groups was similar at time 0 ( p = 0.2142 ) , and different at times 1 ( p = 0.0033 ) and 2 ( p < 0.0006 ) . Increase in IIEF-5 score ( p = 0.0469 ) , TT ( p = 0.0349 ) and FSH levels ( p = 0.0025 ) , and reduction in PRL level ( p < 0.0001 ) were observed in group A from times 0 to 2 and 1 to 2 . There were no changes from times 0 to 1 . Comparing groups A and B at time 2 , IIEF-5 , TT and FT increased significantly in group A ( p = 0.0224 , 0.0043 and 0.0149 respectively ) . Surgery-induced weight loss increased erectile function quality measured by IIEF-5 question naire , increased TT , FT and FSH and reduced PRL levels . The hormonal impact verified could justify the improvement in erectile function .  Lifestyle modifications impacted BMI without hormonal or sexual impact in morbidly obese . New studies are warranted in the field to support our data Background Proven short-term effectiveness of obesity therapy should be re-evaluated in the long-term . The objective of this paper is to determine the long-term ( 10 years ) outcome for patients from a r and omised controlled trial ( RCT ) . Methods A RCT in 2002 compared laparoscopic adjustable gastric b and ( LAGB ) for obesity  with non-surgical therapy . Follow-up has been conducted at 10 years . Eighty patients ( BMI 30–35 ) were r and omised to a non-surgical or a surgical program .  Outcome data are available on 37 ( 92.5 % ) of the surgical patients and 27 ( 62.5 % ) of the non-surgical patients at 10 years . Results Weight change , the metabolic syndrome , quality of life , adverse events and direct costs of the surgical cohort were the main results of the study . A durable weight loss is present in the surgical group with a mean ( SD ) 10-year weight loss of 14.1 ( 7.7 ) kg ( 63.4 % EWL ) , better than the non-surgical group ( mean ( SD ) = 0.4 ( 10.5 ) kg ; p < 0.001 ) . The metabolic syndrome was reduced from 14 to 4 of the 37 patients who completed 10 years within the LAGB groups . Proximal gastric enlargements occurred in 17 ( 30 % ) of the 57 who had LAGB and removal of the b and occurred in 7 ( 12 % ) . The annual maintenance costs including additional surgery was AUD $ 765 per patient per year . Conclusions Bariatric surgery with the LAGB can achieve long-term weight reduction which is better than a program of non-surgical therapy . There is also a sustained reduction of the metabolic syndrome . There is a significant maintenance requirement after LAGB 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 One of the main goals of weight reduction in morbidly obese subjects is its benefit on coronary heart disease ( CHD ) risk . A cross-sectional study was design ed to r and omly assign 79 morbidly obese subjects ( 27 men and 52 women ; age : 30 - 45 years ) either to a diet protocol ( 20 kcal per kg fat-free mass ( FFM ) ; 55 % carbohydrates , 30 % fat , and 15 % proteins ) or to malabsorptive surgery ( biliopancreatic diversion ) .  Fatness parameters , measured by dual-energy X-ray absorptiometry , lipid profile , insulin , leptin , sex steroid hormones and sex hormone-binding globulin ( SHBG ) levels were compared at baseline and 1 year after the beginning of the study . The data showed that plasma SHBG levels , but not testosterone levels , correlated negatively to fasting insulin levels and positively to HDL-cholesterol in both men and women . Total leptin levels were significantly lower ( P<0.0001 ) in post-BPD subjects of both sexes compared to dietary treated obese subjects . The logarithm of plasma leptin correlated significantly and positively with insulin but negatively with SHBG.A step-down regression analysis showed that FFM and SHBG , but not insulin levels , were the most powerful independent variables for predicting HDL-cholesterol levels in morbidly obese patients . The negative relationship between SHBG levels and CHD risk appears to be mediated by a concomitant variation in body fatness . Finally , in obese patients , SHBG levels seem to be an indicator of total adiposity rather than an index of an altered insulin/glucose homeostasis 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 BACKGROUND Bariatric surgery improves glycaemia in obese people with type 2 diabetes , but its effects are uncertain in overweight people with this disease . We aim ed to identify whether laparoscopic adjustable gastric b and surgery can improve glucose control in people with type 2 diabetes who were overweight but not obese . METHODS We did an open-label , parallel-group , r and omised controlled trial between Nov 1 , 2009 , and June 30 , 2013 , at one centre in Melbourne , Australia . Patients aged 18 - 65 years with type 2 diabetes and a BMI between 25 and 30 kg/m2 were r and omly assigned ( 1:1 ) , by computer-generated r and om sequence , to receive either multidisciplinary diabetes care plus laparoscopic adjustable gastric b and surgery or multidisciplinary diabetes care alone . The primary outcome was diabetes remission 2 years after r and omisation , defined as glucose concentrations of less than 7.0 mmol/L when fasting and less than 11.1 mmol/L 2 h after 75 g oral glucose , at least two days after stopping glucose-lowering drugs . Analysis was by intention to treat . This trial is registered with the Australian New Zeal and Clinical Trials Registry , number ACTRN12609000286246 . FINDINGS 51 patients were r and omised to the multidisciplinary care plus gastric b and group ( n=25 ) or the multidisciplinary care only group ( n=26 ) , of whom 23 participants and 25 participants , respectively , completed follow-up to 2 years . 12 ( 52 % ) participants in the multidisciplinary care plus gastric b and group and two ( 8 % ) participants in the multidisciplinary care only group achieved diabetes remission ( difference in proportions 0.44 , 95 % CI 0.17 - 0.71 ; p=0.0012 ) . One ( 4 % ) participant in the gastric b and group needed revisional surgery and four others ( 17 % ) had a total of five episodes of food intolerance due to excessive adjustment of the b and . INTERPRETATION When added to multidisciplinary care , laparoscopic adjustable gastric b and surgery for overweight people with type 2 diabetes improves glycaemic control with an acceptable adverse event profile . Laparoscopic adjustable gastric b and surgery is a reasonable treatment option for this population . FUNDING Monash University Centre for Obesity Research and Education and Allergan 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 CONTEXT Adolescent obesity is a common and serious health problem affecting more than 5 million young people in the United States alone . Bariatric surgery is being evaluated as a possible treatment option . Laparoscopic adjustable gastric b and ing ( gastric b and ing ) has the potential to provide a safe and effective treatment . OBJECTIVE To compare the outcomes of gastric b and ing with an optimal lifestyle program on adolescent obesity . DESIGN , SETTING , AND PATIENTS A prospect i ve , r and omized controlled trial of 50 adolescents between 14 and 18 years with a body mass index ( BMI ) higher than 35 , recruited from the Melbourne , Australia , community , assigned either to a supervised lifestyle intervention or to undergo gastric b and ing , and followed up for 2 years . The study was performed between May 2005 and September 2008 . MAIN OUTCOME MEASURES Weight loss . Secondary outcomes included change in metabolic syndrome , insulin resistance , quality of life , and adverse outcomes . RESULTS Twenty-four of 25 patients in the gastric b and ing group and 18 of 25 in lifestyle group completed the study . Twenty-one ( 84 % ) in the gastric b and ing and 3 ( 12 % ) in the lifestyle groups lost more than 50 % of excess weight , corrected for age . Overall , the mean changes in the gastric b and ing group were a weight loss of 34.6 kg ( 95 % CI , 30.2 - 39.0 ) , representing an excess weight loss of 78.8 % ( 95 % CI , 66.6%-91.0 % ) , 12.7 BMI units ( 95 % CI , 11.3 - 14.2 ) , and a BMI z score change from 2.39 ( 95 % CI , 2.05 - 2.73 ) to 1.32 ( 95 % CI , 0.98 - 1.66 ) . The mean losses in the lifestyle group were 3.0 kg ( 95 % CI , 2.1 - 8.1 ) , representing excess weight loss of 13.2 % ( 95 % CI , 2.6%-21.0 % ) , 1.3 BMI units ( 95 % CI , 0.4 - 2.9 ) , and a BMI z score change from 2.41 ( 95 % CI , 2.21 - 2.66 ) to 2.26 ( 95 % CI , 1.91 - 2.43 ) . At entry , 9 participants ( 36 % ) in the gastric b and ing group and 10 ( 40 % ) in the lifestyle group had the metabolic syndrome . At 24 months , none of the gastric b and ing group had the metabolic syndrome ( P = .008 ; McNemar chi(2 ) ) compared with 4 of the 18 completers ( 22 % ) in the lifestyle group ( P = .13 ) . The gastric b and ing group experienced improved quality of life with no perioperative adverse events . However , 8 operations ( 33 % ) were required in 7 patients for revisional procedures either for proximal pouch dilatation or tubing injury during follow-up . CONCLUSIONS Among obese adolescent participants , use of gastric b and ing compared with lifestyle intervention result ed in a greater percentage achieving a loss of 50 % of excess weight , corrected for age . There were associated benefits to health and quality of life . TRIAL REGISTRATION ANZCTR Identifier : 12605000160639 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 . ) OBJECTIVE To determine the 2-year outcomes of Roux-en-Y gastric bypass ( RYGB ) and sleeve gastrectomy ( SG ) vs. intensive medical therapy ( IMT ) on lean body mass , total bone mass , and bone mineral density ( BMD ) measures from the STAMPEDE trial . METHODS 54 subjects ( BMI : 36 ± 1 kg/m(2 ) , age : 48 ± 4 years ) with type 2 diabetes ( T2DM ) ( HbA1c : 9.7 ± 2 % ) were r and omized to IMT , RYGB , or SG and underwent DXA at baseline and at 1 and 2 years . RESULTS At 2 years , the reduction in BMI was similar after RYGB and SG and was greater than IMT ( P < 0.001 ) . Lean mass was reduced by ∼10 % , total bone mineral content reduced by ∼8 % , and hip BMD reduced by ∼9 % in both surgical groups and was significantly greater than IMT despite increases in vitamin D intake in all groups . The change in hip BMD correlated with weight loss ( r = 0.84 , P < 0.0001 ) and changes in lean mass ( r = 0.74 , P < 0.0001 ) and leptin ( r = 0.53 , P < 0.0001 ) . Peripheral fractures were self-reported in RYGB ( 4/18 patients ) , SG ( 2/19 patients ) , and IMT ( 4/16 patients ) . CONCLUSIONS Surgically induced weight loss is associated with modest reductions in lean mass , bone mineral content , and BMD , despite calcium and vitamin D supplementation in patients with T2DM . Awareness for bone loss is indicated for patients undergoing bariatric procedures CONTEXT Recommendations for surgical , compared with lifestyle and pharmacologically based , approaches for type 2 diabetes ( T2D ) management remain controversial . OBJECTIVE The objective was to compare laparoscopic adjustable gastric b and ( LAGB ) to an intensive medical diabetes and weight management ( IMWM ) program for T2D . DESIGN This was design ed as a prospect i ve , r and omized clinical trial . SETTING The setting was two Harvard Medical School-affiliated academic institutions . INTERVENTIONS AND PARTICIPANTS : A 12-month r and omized trial comparing  LAGB ( n = 23 ) vs  IMWM ( n = 22 ) in persons aged 21 - 65 years with body mass index of 30 - 45 kg/m(2 ) , T2D diagnosed more than 1 year earlier , and glycated hemoglobin ( HbA(1c ) ) ≥ 6.5 % on antihyperglycemic medication(s ) . MAIN OUTCOME MEASURE The proportion meeting the prespecified primary glycemic endpoint , defined as HbA(1c ) < 6.5 % and fasting glucose < 7.0 mmol/L at 12 months , on or off medication . RESULTS After r and omization , five participants did not undergo the surgical intervention . Of the 40 initiating intervention ( 22 males/18 females ; age , 51 ± 10 y ; body mass index , 36.5 ± 3.7 kg/m(2 ) ; diabetes duration , 9 ± 5 y ; HbA(1c ) , 8.2 ± 1.2 % ; 40 % on insulin ) , the proportion meeting the primary glycemic endpoint was achieved in 33 % of the LAGB patients and 23 % of the IMWM patients ( P = .457 ) . HbA(1c ) reduction was similar between groups at both 3 and 12 months ( -1.2 ± 0.3 vs -1.0 ± 0.3 % ; P = .496 ) . Weight loss was similar at 3 months but greater 12 months after LAGB ( -13.5 ± 1.7 vs -8.5 ± 1.6 kg ; P = .027 ) . Systolic blood pressure reduction was greater after IMWM than LAGB , whereas changes in diastolic blood pressure , lipids , fitness , and cardiovascular risk scores were similar between groups . Patient-reported health status , assessed using the Short Form-36 , Impact of Weight on Quality of Life , and Problem Areas in Diabetes , all improved similarly between groups . CONCLUSIONS LAGB and a multidisciplinary IMWM program have similar 1-year benefits on diabetes control , cardiometabolic risk , and patient satisfaction , which should be considered in the context of other factors , such as personal preference , when selecting treatment options with obese T2D patients . Longer duration studies are important to underst and emergent differences
target: Furthermore , except for certain cardiovascular indicators , bariatric surgery was superior to conventional arms in terms of metabolic secondary parameters ( P < 0.05 ) .
  Bariatric surgery is a better therapeutic option for weight loss , irrespective of follow-up duration , surgical techniques and obesity levels
background: BACKGROUND Bariatric surgery has emerged as a competitive strategy for obese patients .
  However , its comparative efficacy against non-surgical treatments remains ill-defined , especially among nonseverely obese crowds .