Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Observational studies suggest that bariatric surgery is the most effective intervention for weight loss. Comparative effectiveness of Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) demonstrate that RYGB is significantly superior to SG in terms of weight loss and glycemic control. Both RYGB and SG increase GLP-1 concentrations which directly affect B-cell function. Data has shown that the postprandial rise in GLP-1 might affect feeding behavior after RYGB and to a lesser extent SG, where the increase in GLP-1 is less marked. In this study the investigators propose to randomize subjects undergoing SG to receive either placebo or Liraglutide, a GLP-1 receptor agonist, to compare weight loss and CV risk factors.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Novo Nordisk A/S
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

1. Age 20-65 years of age

2. Seen at Mayo Clinic Nutrition Clinic and have received authorization for bariatric surgery.

3. No active physical illness which will interfere with mobility or weight loss after bariatric surgery.

4. Females who are sexually active and able to become pregnant must agree to use birth control for duration of study if randomized to Saxenda/Placebo.

Exclusion Criteria:

1. Prior use of glucose lowering medication in the 3 months prior to screening.

2. A fasting glucose ≥ 126mg/dl or an HbA1c ≥ 6.5% will be taken as evidence of type 2 diabetes and therefore patients will be deemed ineligible for participation.

3. Prior abdominal surgery other than cholecystectomy, appendectomy or hysterectomy.

4. Pregnancy or active consideration of pregnancy during the period of study. Subjects will be discontinued if they become pregnant during the study.

5. Hypersensitivity to liraglutide or any product components.

6. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2.

7. Prior history of pancreatitis, cholelithiasis or cholecystitis.

8. Concurrent use of insulin or any other GLP-1 receptor agonist.

9. Active, severe psychiatric disease