At a glance
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NCT06363747Phase 3ActiveUpdate OverdueUpdated 16mo ago · Completion was 7mo agoThe Medically Reproducing Bariatric Surgery (MRB) II Study: SEMAGLUTIDE Followed by OPTIFAST in Veterans With Type 2 Diabetes
In Brief
A Phase 3 clinical trial evaluating Very Low Calorie Diet for Type 2 Diabetes and Obesity. Active but no longer recruiting, targeting 50 participants across 1 site.
Signals
Detailed Summary
Roux-en-Y (RYGB) gastric bypass reduces the size and capacity of the stomach and bypasses a portion of the small intestine which leads to decreased food intake and higher levels of a gut hormone called GLP-1 (glucagon-like-peptide-1). These changes lead to weight loss, improved blood sugars and often remission of type 2 diabetes but most patients do not qualify or want surgery. The investigators are searching for ways to make the beneficial effects of RYGB available to most type 2 diabetes patients rather than a select few that undergo RYGB. The investigators believe that parts of RYGB can be medically reproduced through a combination of diet and medicine. Once weekly injectable GLP-1 medicine that leads to weight loss and improved blood sugar control in type 2 diabetes are now FDA approved. Optifast is a medically supervised diet that safely reduces calorie intake to 800 calories per day for three months by replacing normal meals with specially prepared bars and shakes which leads to weight loss and improved blood sugar control in type 2 diabetes. Normal meals are then gradually reintroduced over 6 weeks and the bars/shakes are stopped. The investigators hypothesize that Optifast (diet) + once weekly GLP-1 will lead to weight loss and improvement in blood sugar control in type 2 diabetes similar to what is seen after RYGB.
Study Details
Timeline
Interventions
Optifast is a medically supervised very low-calorie diet (VLCD) diet that safely induces caloric restriction