title: Undue reliance on I2 in assessing heterogeneity may mislead 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. 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. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Treatment of Mild to Moderate Obesity with Laparoscopic Adjustable Gastric Banding or an Intensive Medical Program 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. Effect of laparoscopic Roux-en-Y gastric bypass surgery on type 2 diabetes mellitus with hypertension: a randomized controlled trial. Changes in body composition with weight loss: obese subjects randomized to surgical and medical programs. Sex hormone-binding globulin levels and cardiovascular risk factors in morbidly obese subjects before and after weight reduction induced by diet or malabsorptive surgery. Health benefits of gastric bypass surgery after 6 years. Quality of reporting in randomized trials published in high-quality surgical journals. Laparoscopic adjustable gastric banding in severely obese adolescents: a randomized trial.
abstract: Background The heterogeneity statistic I2 , interpreted as the percentage of variability due to heterogeneity between studies rather than sampling error , depends on precision , that is , the size of the studies included . Methods Based on a real meta- analysis , we simulate artificially ' inflating ' the sample size under the r and om effects model . For a given inflation factor M = 1 , 2 , 3 , ... and for each trial i , we create a M-inflated trial by drawing a treatment effect estimate from the r and om effects model , using si2MathType@MTEF@5@5@+=feaagaart1ev2aaatCvAUfKttLearuWrP9MDH5MBPbIqV92AaeXatLxBI9gBaebbnrfifHhDYfgasaacPC6xNi = xH8viVGI8Gi = hEeeu0xXdbba9frFj0xb9qqpG0dXdb9aspeI8k8fiI+fsY = rqGqVepae9pg0db9vqaiVgFr0xfr = xfr = xc9adbaqaaeGaciGaaiaabeqaaeqabiWaaaGcbaGaem4Cam3aa0baaSqaaiabdMgaPbqaaiabikdaYaaaaaa@2FBE@/M as within-trial sampling variance . Results As precision increases , while estimates of the heterogeneity variance τ2 remain unchanged on average , estimates of I2 increase rapidly to nearly 100 % . A similar phenomenon is apparent in a sample of 157 meta-analyses . Conclusion When deciding whether or not to pool treatment estimates in a meta- analysis , the yard-stick should be the clinical relevance of any heterogeneity present . τ2 , rather than I2 , is the appropriate measure for this purpose 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 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 In the 2.8 years of the Diabetes Prevention Program ( DPP ) r and omised clinical trial ,  diabetes incidence  in high-risk adults was reduced by 58 % with intensive lifestyle intervention and by 31 % with metformin , compared with placebo . We investigated the persistence of these effects in the long term . METHODS All active DPP participants were eligible for continued follow-up . 2766 of 3150 ( 88 % ) enrolled for a median additional follow-up of 5.7 years ( IQR 5.5 - 5.8 ) . 910 participants were from the lifestyle , 924 from the metformin , and 932 were from the original placebo groups .  On the basis of the benefits from the intensive lifestyle intervention in the DPP , all three groups were offered group-implemented lifestyle intervention . Metformin treatment was continued in the original metformin group ( 850 mg twice daily as tolerated ) , with participants unmasked to assignment , and the original lifestyle intervention group was offered additional lifestyle support . The primary outcome was development of diabetes according to American Diabetes Association criteria . Analysis was by intention-to-treat . This study is registered with Clinical Trials.gov , number NCT00038727 . FINDINGS During the 10.0-year ( IQR 9.0 - 10.5 ) follow-up since r and omisation to DPP , the original lifestyle group lost , then partly regained weight . The modest weight loss with metformin was maintained . Diabetes incidence rates during the DPP were 4.8 cases per 100 person-years ( 95 % CI 4.1 - 5.7 ) in the intensive lifestyle intervention group , 7.8 ( 6.8 - 8.8 ) in the metformin group , and 11.0 ( 9.8 - 12.3 ) in the placebo group . Diabetes incidence rates in this follow-up study were similar between treatment groups : 5.9 per 100 person-years ( 5.1 - 6.8 ) for lifestyle , 4.9 ( 4.2 - 5.7 ) for metformin , and 5.6 ( 4.8 - 6.5 ) for placebo . Diabetes incidence in the 10 years since DPP r and omisation was reduced by 34 % ( 24 - 42 ) in the lifestyle group and 18 % ( 7 - 28 ) in the metformin group compared with placebo . INTERPRETATION During follow-up after DPP , incidences in the former placebo and metformin groups fell to equal those in the former lifestyle group , but the cumulative incidence of diabetes remained lowest in the lifestyle group . Prevention or delay of diabetes with lifestyle intervention or metformin can persist for at least 10 years . FUNDING National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) Context Observational studies have shown sustained weight loss after surgery for extreme obesity . No r and omized trial of contemporary surgical methods has been performed . Contribution The authors r and omly assigned 80 mildly to moderately obese ( body mass index , 30 to 35 kg/m2 ) adults to laparoscopic placement of an adjustable gastric b and or to an intensive nonsurgical weight loss program . After 2 years , the surgical group had lost 21.6 % of initial weight , and the nonsurgical group had lost 5.5 % of initial weight . Four patients required laparoscopic revision of the gastric b and . Caution s The study was not design ed to detect uncommon adverse events . Implication s Laparoscopic gastric b and ing is effective treatment for mild to moderate obesity . The Editors The development of a safe and effective treatment for obesity is a leading challenge in health care today . Obesity is an increasing health problem across the world with a prevalence of more than 20 % among the adult population in Western countries and more than 30 % in the United States ( 1 , 2 ) . The increasing prevalence is associated with a parallel increase of several obesity-related diseases , in particular , the diseases of the metabolic syndrome ( 3 , 4 ) , which include type 2 diabetes , hypertension , and dyslipidemia , and are linked to nonalcoholic steatohepatitis , obstructive sleep apnea , and the polycystic ovary syndrome . For obese individuals , the options are limited . Behavioral therapies of reduced energy intake , improved eating practice s , and increased exercise and activity , supplemented by pharmacotherapy , generally achieve only modest and often transient effects ( 5 , 6 ) . Observational studies have shown that bariatric surgical therapies involving gastric restriction by various forms of stapling with or without diversion of the gut to generate malabsorption of food are effective in achieving major weight loss and clinical ly significant improvements in health and quality of life ( 7 - 11 ) . Strong direct evidence from r and omized , controlled trials of the relative benefits of nonsurgical and surgical therapies is lacking . We are aware of only a single study , performed in the 1980s , in which 60 morbidly obese patients were r and omly assigned , without informed consent , to diet plus an early form of gastric stapling or to diet alone ( 12 ) . The maximum weight losses did not differ between the groups . However , the weight regain was greater in the diet-only group . The advent of the laparoscopic adjustable gastric b and has provided a new bariatric surgical option , which has proved to be safe , minimally invasive in its application , gentle in its use through its adjustability and easy reversibility , and similarly effective to the other bariatric procedures ( 10 , 13 , 14 ) . Figure 1 shows the LAP-B AND System ( INAMED Health , Santa Barbara , California ) and demonstrates the key feature of adjustability of the area within the b and through which it induces satiety ( 15 ) . Patients require no more than an overnight hospital stay , and the procedure has been shown to be markedly safer than gastric bypass surgery ( 13 ) . Figure 1 . The laparoscopic adjustable gastric b and ( LAP-B AND System , INAMED Health , Santa Barbara , California ) with no added fluid ( top ) and with 2 mL of fluid added ( bottom ) . We hypothesized that surgical therapy would induce more weight loss , health benefit , and improvement in quality of life than nonsurgical therapy and have conducted a r and omized , controlled trial comparing the effectiveness of current nonsurgical therapy with laparoscopic adjustable gastric b and ing in a group of mildly to moderately obese adults ( body mass index , 30 kg/m2 to 35 kg/m2 ) . We did not study patients with a body mass index greater than 35 kg/m2 because current observational data suggest that outcomes after nonsurgical treatment were unlikely to be equal to those after surgical care for these patients . The principal outcome measures were weight change , health , quality of life , and complications of therapy . Methods Patient Recruitment We recruited patients for the study through a newspaper advertisement . All patient assessment s and outpatient treatments were conducted at a community clinic dedicated to obesity management or in the clinics of a university department of surgery . Surgical procedures were conducted at a private community hospital experienced in the care of bariatric surgical patients . Patients in both groups did not pay any medical costs generated by the study . The human ethics committees of The Alfred Hospital and The Avenue Hospital approved the study in accordance with the guidelines of the National Health and Medical Research Council ( www.nhmrc.gov.au/publications/synopses/e35syn.htm ) and with the Helsinki Declaration of 1975 , as revised in 2000 ( www.wma.net/e/ethicsunit/pdf/draft_historical_contemporary_perspectives.pdf ) . Inclusion Criteria We considered patients to be eligible if they were between 20 and 50 years of age ; had a body mass index of 30 kg/m2 to 35 kg/m2 ; had identifiable problems , including an obesity-related comorbid condition ( such as hypertension , dyslipidemia , diabetes , obstructive sleep apnea , or gastroesophageal reflux disease ) , severe physical limitations , or clinical ly significant psychosocial problems associated with their obesity ; had attempted to reduce weight over at least the previous 5 years ; could underst and the options offered and the r and omization process ; and were willing to comply with the requirements of each program . Exclusion Criteria We excluded c and i date s with a history of bariatric surgery or medical problems that contraindicated treatment in either study group , such as impaired mental status , drug or alcohol addiction , or portal hypertension . In addition , we excluded participants if they had undergone an intensive , physician-supervised program that used very-low-calorie diets or pharmacotherapy or if they did not attend the 2 initial patient information visits . Assessment We provided detailed information about the problems of obesity and about the 2 study groups through at least 2 discussion periods and a patient information booklet . Initial assessment included anthropometric measures ; identification of medical , physical , or psychosocial problems ( both weight-related and other ) ; and a discussion of previous weight loss efforts . The assessment included a detailed dietary history by the trial dietitian and a review by a specialist physician to determine the presence and severity of associated medical conditions . Initial investigations included measurements of fasting blood glucose level ; serum insulin level ; and a lipid profile , including HDL cholesterol and LDL cholesterol levels . After initial assessment , we instituted a program of advice on appropriate eating patterns and exercise and followed each patient on a monthly basis for 3 months . During this time , we assessed the patients ' fulfillment of tasks , such as completion of a food diary , and overall adherence to appointments . R and omization Process We r and omly allocated eligible patients to receive a conventional , intensive , nonsurgical program or laparoscopic adjustable gastric b and ing .  A computer-derived r and om allocation sequence , without blocking or stratification , performed the r and omization . This was prepared at the trial office . The trial coordinator enrolled participants and informed them of the trial allocation . After assessment had confirmed a participant 's suitability for r and omization , the coordinator contacted the trial office by telephone for allocation . The study was not blinded . Description of Nonsurgical and Surgical Interventions Common Program We instructed and encouraged all patients to follow appropriate lifestyle behavior of good eating practice s and increased exercise and activity . We also encouraged them to exercise for at least 200 minutes per week . Nonsurgical Program This program centered on the use of behavioral modification , very-low-calorie diet , and pharmacotherapy with education and professional support on appropriate eating and exercise behavior . During the 2-year period , 3 trained physicians developed a program using all the available modalities for each individual on the basis of guidelines prepared and continually review ed by a panel of experienced bariatric physicians . The program began with an intensive 6-month period of very-low-calorie diet ( 500 to 550 kcal/d ) using 1 to 3 packets of Optifast ( Novartis , Fremont , Michigan ) daily for 12 weeks , followed by a transition phase over 4 weeks combining some very-low-calorie meals with 120 mg of orlistat before nonvery-low-calorie diet meals , and then 120 mg of orlistat before all meals until the completion of the intensive phase . This intensive 6-month program was followed by further courses of very-low-calorie diets or orlistat as tolerated , as well as continual behavioral , dietary , and exercise advice to assist the participant in maintaining weight loss over a prolonged period . Sibutramine was not approved for use in Australia during the first 12 months of the study and , therefore , was not incorporated into the medical program . The management program for each individual was design ed to reflect good clinical practice . A physician saw each patient every 2 weeks during the very-low-calorie diet program and every 4 to 6 weeks during the rest of the study . All patients were seen at least every 6 weeks . Surgical Program Two experienced surgeons performed the laparoscopic adjustable gastric b and ( LAP-B AND System ) procedure , by a st and ardized method ( 14 ) , within 1 month of r and omization . The b and was placed along the perigastric pathway in all cases ( 16 ) . The treating surgeon review ed patient progress every 4 to 6 weeks during the study period and made adjustments to the volume of saline within the b and in the office by using st and ard clinical criteria ( 17 ) . Adverse Events All patients in the study were question ed about the occurrence of adverse events at each consultation , and physicians recorded the 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 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 OBJECTIVE To assess changes in body composition with weight loss in obese subjects r and omized to a laparoscopic adjustable gastric b and surgical program or a medical program using a very-low-energy diet and orlistat .  RESEARCH METHODS AND PROCEDURES Using body composition measurements by DXA , neutron activation for total body nitrogen , and whole body gamma counting for total body potassium , we studied changes in fat mass , fat distribution , fat-free mass , total bone mineral content , total body protein , and body cell mass at 6 ( n = 61 paired ) and 24 months ( n = 53 paired ) after r and omization . RESULTS At 24 months , the surgical group had lost significantly more weight ( surgical , 20.3 + /- 6.5 kg ; medical , 5.9 + /- 8.0 kg ) . There was favorable fat-free mass to fat mass loss ratios for both groups ( surgical , 1:5.5 ; medical , 1:5.9 ) . Changes in total body nitrogen or potassium were favorable in each group . A small reduction in mean bone mineral content occurred throughout the study but was not associated with extent of weight loss or treatment group . At 6 months , weight loss for both groups was similar ( surgical , 14.1 + /- 4.5 kg ; medical , 13.3 + /- 7.3 kg ) . The medical program subjects lost less fat-free mass and skeletal muscle and had increased total body protein . The proportion of body fat to limb fat remained remarkably constant throughout the study . DISCUSSION Weight loss programs used in this study induced fat loss without significant deleterious effects on the components of fat-free mass 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 CONTEXT Extreme obesity is associated with health and cardiovascular disease risks . Although gastric bypass surgery induces rapid weight loss and ameliorates many of these risks in the short term , long-term outcomes are uncertain . OBJECTIVE To examine the association of  Roux-en-Y gastric bypass ( RYGB ) surgery  with weight loss , diabetes mellitus , and other health risks 6 years after surgery . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve Utah-based study conducted between July 2000 and June 2011 of 1156 severely obese ( body mass index [ BMI ] ≥ 35 ) participants aged 18 to 72 years ( 82 % women ; mean BMI , 45.9 ; 95 % CI , 31.2 - 60.6 ) who sought and received RYGB surgery ( n = 418 ) , sought but did not have surgery ( n = 417 ; control group 1 ) , or who were r and omly selected from a population -based sample not seeking weight loss surgery ( n = 321 ; control group 2 ) . MAIN OUTCOME MEASURES Weight loss , diabetes , hypertension , dyslipidemia , and health-related quality of life were compared between participants having RYGB surgery and control participants using propensity score adjustment . RESULTS Six years after surgery , patients who received RYGB surgery ( with 92.6 % follow-up ) lost 27.7 % ( 95 % CI , 26.6%-28.9 % ) of their initial body weight compared with 0.2 % ( 95 % CI , -1.1 % to 1.4 % ) gain in control group 1 and 0 % ( 95 % CI , -1.2 % to 1.2 % ) in control group 2 . Weight loss maintenance was superior in patients who received RYGB surgery , with 94 % ( 95 % CI , 92%-96 % ) and 76 % ( 95 % CI , 72%-81 % ) of patients receiving RYGB surgery maintaining at least 20 % weight loss 2 and 6 years after surgery , respectively . Diabetes remission rates 6 years after surgery were 62 % ( 95 % CI , 49%-75 % ) in the RYGB surgery group , 8 % ( 95 % CI , 0%-16 % ) in control group 1 , and 6 % ( 95 % CI , 0%-13 % ) in control group 2 , with remission odds ratios ( ORs ) of 16.5 ( 95 % CI , 4.7 - 57.6 ; P < .001 ) vs control group 1 and 21.5 ( 95 % CI , 5.4 - 85.6 ; P < .001 ) vs control group 2 . The incidence of diabetes throughout the course of the study was reduced after RYGB surgery ( 2 % ; 95 % CI , 0%-4 % ; vs 17 % ; 95 % CI , 10%-24 % ; OR , 0.11 ; 95 % CI , 0.04 - 0.34 compared with control group 1 and 15 % ; 95 % CI , 9%-21 % ; OR , 0.21 ; 95 % CI , 0.06 - 0.67 compared with control group 2 ; both P < .001 ) . The numbers of participants with bariatric surgery-related hospitalizations were 33 ( 7.9 % ) , 13 ( 3.9 % ) , and 6 ( 2.0 % ) for the RYGB surgery group and 2 control groups , respectively . CONCLUSION Among severely obese patients , compared with nonsurgical control patients , the use of RYGB surgery was associated with higher rates of diabetes remission and lower risk of cardiovascular and other health outcomes over 6 years BACKGROUND R and omized controlled trials ( RCTs ) in surgery can provide valuable evidence of the efficacy of interventions if they are well- design ed , appropriately executed , and adequately reported . Adequate reporting of methodology in surgical RCTs is known to be poor , and adverse-event reporting in surgical research is inconsistent . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement is a framework to help authors report their findings in a transparent manner . Extensions to the CONSORT statement have been published recently to address deficiencies in adverse-event reporting and in reporting of specific criteria related to nonpharmacologic treatments . The aim of this study was to assess the quality of reporting of trial methodology and adverse events in a sample of general surgical RCTs published in high- quality surgical journals using the criteria specified in the CONSORT statements . STUDY DESIGN We used impact factor to identify the top three ranked surgical journals in 2004 . We then obtained information on all RCTs published in these journals in the 2005 calendar year . We assessed quality of reporting using Jadad score , compared the quality of RCTs from CONSORT-endorsing journals with nonendorsers , and assessed the number of RCTs adequately reporting key generic method ologic , adverse-event-related , and specific nonpharmacologic criteria . RESULTS Of 42 RCTs analyzed , only 40 % ( 17 of 42 ) had a Jadad score > or = 3 . There was no significant difference in the number of high- quality RCTs published in CONSORT-endorsing journals compared with nonendorsers ( p = 0.3 ) . The median percentage of RCTs adequately reporting generic method ologic , adverse-event-related , and specific nonpharmacologic criteria was 32.5 % , 17 % , and 36.5 % , respectively . CONCLUSIONS Quality of reporting of generic method ologic , adverse-event-related , and specific nonpharmacologic criteria in surgical RCTs is poor . Increased attention to quality of reporting of surgical RCTs is required if studies are to meet published criteria 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
target: Compared with non-surgical treatment of obesity , bariatric surgery leads to greater body weight loss and higher remission rates of type 2 diabetes and metabolic syndrome .
background: OBJECTIVE To quantify the overall effects of bariatric surgery compared with non-surgical treatment for obesity .