The medicine use and quality of life were solely improved in the surgical group .
Nutritional deficiencies and anemia were noted more frequently in the RYGB group .
RYGB surgery is superior to medical treatment for short- to medium-term remission of T2DM , improvement of metabolic condition , and cardiovascular risk factors .
Abstract The aim of the study is to compare Roux-en-Y gastric bypass ( RYGB ) surgery versus medical treatment for  type 2 diabetes mellitus ( T2DM ) in obese patients .Bariatric  surgery can achieve remission of T2DM in obese patients .
RYGB surgery has been performed as one of the most common surgical treatment options for obese patients with T2DM , but the efficacy of RYGB surgery comparing with medical treatment alone has not been conclusively determined .
Roux-en-Y gastric bypass for diabetes (the Diabetes Surgery Study): 2-year outcomes of a 5-year, randomised, controlled trial.
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
The medicine use and quality of life were solely improved in the surgical group .
Nutritional deficiencies and anemia were noted more frequently in the RYGB group .
RYGB surgery is superior to medical treatment for short- to medium-term remission of T2DM , improvement of metabolic condition , and cardiovascular risk factors .
Abstract The aim of the study is to compare Roux-en-Y gastric bypass ( RYGB ) surgery versus medical treatment for  type 2 diabetes mellitus ( T2DM ) in obese patients .Bariatric  surgery can achieve remission of T2DM in obese patients .
RYGB surgery has been performed as one of the most common surgical treatment options for obese patients with T2DM , but the efficacy of RYGB surgery comparing with medical treatment alone has not been conclusively determined .