Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial.

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 randomized 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 randomized 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 banding [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 resulted in more disease remission than did lifestyle intervention alone. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01047735.

Surgical vs medical treatments for type 2 diabetes mellitus: a randomized clinical trial.

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 randomized clinical trial (RCT) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating T2DM in participants with grades 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 banding (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 randomized. Among the randomized 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 randomization, 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 randomizing 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: clinicaltrials.gov Identifier: NCT01047735.

StomaphyX vs a sham procedure for revisional surgery to reduce regained weight in Roux-en-Y gastric bypass patients : a randomized clinical trial.

IMPORTANCE: Revisional laparoscopic surgery after Roux-en-Y gastric bypass (RYGB) has been linked to substantial complications and morbidity. OBJECTIVE: To investigate the safety and effectiveness of endoscopic gastric plication with the StomaphyX device vs a sham procedure for revisional surgery in RYGB patients to reduce regained weight. DESIGN, SETTING, AND PARTICIPANTS: A prospective, single-center, randomized, single-blinded study from July 2009 through February 2011, evaluating revisional surgery using StomaphyX was conducted in patients with initial weight loss after RYGB performed at least 2 years earlier. We planned for 120 patients to be randomized 2:1 to multiple full-thickness plications within the gastric pouch and stoma using the StomaphyX device with SerosFuse fasteners or a sham endoscopic procedure and followed up for 1 year. The primary efficacy end point was reduction in pre-RYGB excess weight by 15% or more excess body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) loss and BMI less than 35 at 12 months after the procedure. Adverse events were recorded. RESULTS: Enrollment was closed prematurely because preliminary results indicated failure to achieve the primary efficacy end point in at least 50% of StomaphyX-treated patients. One-year follow-up was completed by 45 patients treated with StomaphyX and 29 patients in the sham treatment group. Primary efficacy outcome was achieved by 22.2% (10) with StomaphyX vs 3.4% (1) with the sham procedure (P < .01). Patients undergoing StomaphyX treatment experienced significantly greater reduction in weight and BMI at 3, 6, and 12 months (P ≤ .05). There was one causally related adverse event with StomaphyX, that required laparoscopic exploration and repair. CONCLUSIONS AND RELEVANCE: StomaphyX treatment failed to achieve the primary efficacy target and resulted in early termination of the study. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00939055.

Longitudinal Assessment of Bariatric Surgery (LABS): retention strategy and results at 24 months.

BACKGROUND: Retaining participants in observational longitudinal studies after bariatric surgery is difficult yet critical because the retention rate affects interpretation and generalizability of results. Strategies for keeping participants involved in such studies are not commonly published. The objective of this study was to review LABS retention strategies and present the 24-month retention data. METHODS: The LABS Consortium monitors an observational cohort study of 2458 adults enrolled before bariatric surgery at 10 centers within the United States (LABS-2). To maximize data completeness, the investigators developed retention strategies, including flexible scheduling, a call protocol, reminder letters, abbreviated visit options, honoraria, travel reimbursement, providing research progress reports, laboratory results, newsletters, study website, and retention surveys. Strategies for locating participants included frequent updates of contact information, sending registered letters, and searching medical and public records. RESULTS: At 12 and 24 months, 2426 and 2405 participants remained active, with vital status known for 98.7% and 97.3% and weight obtained for 95.2% and 92.2%, respectively. There were 148 missed visits (6.2%) at 24 months primarily because of inability to contact the participant. Only 15 (0.6%) active participants at 24 months missed all follow-up visits. Although 42 participants could not be located or contacted at 6 months, data were obtained for 23 (54.7%) of them at 12 months, and of the 52 participants who could not be located or contacted at 12 months, data were obtained for 18 (34.6%) at 24 months. CONCLUSION: Longitudinal studies provide the ability to evaluate long-term effects of bariatric surgical procedures. The retention achieved in LABS is superior to that of many published reports but requires extensive effort and resources. This report identifies useful retention strategies. Further research is needed to identify the efficacy and cost-effectiveness of specific retention strategies.