Journal of Clinical Trials
Open Access

Abstract

Lessons Learned from a Randomized Controlled Trial of Bariatric Surgery versus Intensive Lifestyle Modification for Individuals with Type 2 Diabetes

Scott Ritter, David B Sarwer, Jacqueline C Spitzer, Marion L Vetter, Reneé H Moore, Noel N Williams and Thomas A Wadden

Objective: Relatively few Randomized Controlled Trials (RCTs) have compared bariatric surgery to lifestyle modification for weight loss and improvements in type 2 diabetes. The Surgery or Lifestyle Intervention for Diabetes
(SOLID) RCT was designed to address this insufficiency by comparing
(1) Roux-en-Y Gastric Bypass surgery (RYGB),
(2) Adjustable Gastric Banding surgery (AGB), and
(3) A non-surgical Intensive Lifestyle Modification (ILM) for weight loss on changes in weight and diabetes status.
Methods: SOLID was a RCT for the first 24 months, but due to low enrollment, was modified to a prospective observational study for the last 12 months.
Results: In total, 1,290 individuals inquired about the study and completed initial screening. Of these, 209 were eligible, however only 18 were enrolled in the trial (3 RYGB, 3 AGB, 12 ILM). Multiple barriers to patient enrollment were identified, including issues related to the eligibility criteria, reluctance to accept random assignment to the three interventions, and lack of insurance coverage or availability of funds to pay for the bariatric procedures.
Conclusion: These issues warrant thoughtful attention from investigators who are planning future RCTs in this area.