What this trial means for you
This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying see the official record for type 2 diabetes, obesity.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Inclusion Criteria: * male or female * age 25-75 years * BMI \>27 * diagnosis of type 2 diabetes * weight stable for 1 month * hemoglobin A1C \>7.0% * on stable dose of once weekly GLP-1 agonist * on oral or injectable DM2 medicines * interested in losing weight * agreeable to regular visits per study protocol * access to telephone and reliable transportation and has a VAMC provider * using a Freestyle Libre glucose monitoring device and/or glucometer device Exclusion Criteria: * age \>75, * A1C \<7% * pregnant * breast feeding * prior history of pancreatitis * prior history of gastroparesis * history of thyroid cancer/multiple endocrine neoplasia/thyroid nodules/medullary thyroid cancer (contraindication to Liraglutide) * history of gallstones * history of hyperoxaluria or calcium oxalate nephrolithiasis * history of Roux-en-Y gastric bypass or gastric sleeve or any other bariatric procedure, * type 1 diabetes * any abnormality on the screening EKG that could subject patient to increased risk during the study * any gastrointestinal condition causing malabsorption (including but not limited to inflammatory bowel disease, celiac sprue) * unwilling or unable to complete scheduled testing * any serious and/or unstable medical, psychiatric, or other condition(s) that prevents the patient from providing informed consent or complying with the study * organ transplantation or those on immunosuppressants * chronic anticoagulation * recent myocardial infarction, unstable angina, stroke, coronary artery bypass or transient ischemia attacks in the past 6 months * chronic prednisone use * hepatitis * cirrhosis * GFR \<50 * deep vein thrombosis in past 6 months * active malignancy * unstable psychiatric condition including active or current suicidal ideation * enrolled in another research study related to diet and/or physical activity
Study sites by state
North Carolina
- Greenville VA Health Care Center — Greenville
View the official record on ClinicalTrials.gov →
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