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Large-scale randomized clinical trials are needed to assess the role of Roux-en-Y gastric bypass (RYGB) in treating patients with type 2 diabetes mellitus (T2DM). Recruitment challenges must be understood.One hundred twenty participants were needed for a prospective randomized controlled trial investigating treatments for hyperglycemia and cardiovascular disease risk factors in patients with T2DM. The trial had two arms-intensive medical management plus a rigorous lifestyle intervention (LS/IMM) versus LS/IMM with RYGB. Medical inclusion criteria included glycosylated hemoglobin (HbA1c) ≥ 8.0 % while under the care of a physician and body mass index (BMI) 30.0-39.9 kg/m(2). Another inclusion criterion was expressed willingness to accept randomization and participate fully. Varied recruitment strategies were employed at four academic hospitals in the USA and Taiwan, including referrals, mass media, direct mail to patients drawn from a practice-based database, and direct mail to commercial mailing lists.Between February 2008 and December 2011, 2,648 candidates were phone-screened and 240 were screened on site; 120 participants were eventually randomized. Impediments included stringent medical inclusion criteria and a lack of equipoise (i.e., strong beliefs or preferences) among patients and their personal community-based physicians. To meet timeline requirements, the upper limit for BMI was increased from 34.9 to 39.9 kg/m(2) and an additional site was added.We successfully recruited 120 participants with poorly controlled T2DM and mild to moderate obesity. Participants had to be willing to accept randomization to either surgical or nonsurgical treatments. Recruitment took 4 years.

Background The purpose of this study is to compare effects of different nations on Roux-en-Y gastric bypass (RYGB) vs. intensive medical management (IMM) in achieving remission of type 2 diabetes mellitus (T2DM). Materials and Methods Between April 2008 and December 2011, this randomized, controlled clinical trial was conducted at four teaching hospitals in the United States and Taiwan involving 71 participants with mild obesity (BMI 30–35 kg/m2). Thirty-six of 71 participants were randomly assigned to the RYGB group, and the others were in IMM group. Partial or complete remission of T2DM was defined as blood HbA1c

Summary Background Conventional treatments for patients with type 2 diabetes are often inadequate. We aimed 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 randomised trial (the Diabetes Surgery Study) at four teaching hospitals (three in the USA and one in Taiwan). At baseline, eligible participants had to have HbA 1c 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 randomly assigned participants to receive either intensive lifestyle and medical management alone (lifestyle and medical management), or lifestyle and medical management plus standard 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 HbA 1c 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 ClinicalTrials.gov, number NCT00641251, and is still ongoing. Findings Between April 21, 2008, and Nov 21, 2011, we randomly 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 (HbA 1c vs 14 [24%]; treatment difference −1·9% (−2·5 to −1·4); p=0·0001). 46 clinically 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.

Background: It is unusual for a patient to manifest both morbid obesity and hyperlipidemia. Certain of these individuals may also have a history of hypertriglyceridemic pancreatitis. We report six morbidly obese hypercholesterolemic patients, two with recurrent hypertriglyceridemic pancreatitis, who were managed by concurrent gastric restrictive surgery and a partial ileal bypass operation. Methods: The first dual procedure was performed on January 6 1992, and the most recent on February 20 1997. Our series consists of two males and four females, with an average age of 35.5 years at the time of surgery. The mean preoperative weight of these patients was 116.8 kg, and the mean BMI was 39.7 kg/m2. The preoperative mean total plasma cholesterol was 5.5 g/l and the mean plasma triglyceride was 30.61 g/l; the two patients with a history of hypertriglyceridemic pancreatitis had plasma triglyceride levels of 33.6 g/l and 65 g/l. Results: The average weight reduction, using available follow-up intervals was 40.3 kg (34.5%), with a mean postoperative BMI of 20.0 kg/m2 (34.8% reduction). The markedly elevated total plasma cholesterol and plasma triglyceride levels were normalized, with a postoperative mean total plasma cholesterol of 1.47 g/l (73.3% reduction) and a concomitant mean plasma triglyceride of 1.63 g/l (94.7% reduction). The two patients with a history of pancreatitis sustained triglyceride reductions of 96.5% and 94.1%, and neither patient has had an episode of pancreatitis following the dual operative procedures. Conclusion: We conclude that the combination of a gastric restrictive operation with a partial ileal bypass procedure represents excellent management for patients with both morbid obesity and hypercholesterolemia, especially if the hypercholesterolemia is accompanied by hypertriglyceridemic pancreatitis.