Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy

Phase 3

Completed

• Conditions: Obesity
• Interventions: Procedure: RYGB; Drug: Placebos; Drug: Saxenda

• Registration Number: NCT03115424
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

A total of 75, non diabetic adults, scheduled for bariatric surgery at Mayo Clinic Rochester, will be enrolled. Of these, 25 will be scheduled for Roux-en-Y Gastric Bypass surgery (RYGB), while the remainder (50) will be scheduled for Sleeve Gastrectomy (SG). The study team will play no role in assignment of the surgical procedure. Following surgery, at month 3, subjects undergoing SG will be randomized to either Saxenda or placebo, subcutaneously once daily. Subjects randomized to Saxenda or placebo will take for the duration of the study (33 months). Follow up study visits for all subjects will be timed to coincide with the standard clinical follow up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.

Study Timeline

• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-11
• Study First Posted: 2017-04-14
• Study Start: 2017-06-22
• Primary Completion: 2023-10-04
• Study Completion: 2024-05-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RYGB	RYGB	Twenty five subjects will be recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.
Sleeve Gastrectomy Placebo	Placebos	Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.
Sleeve Gastrectomy Saxenda	Saxenda	Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.

Primary Outcome Measures

Name	Time	Method
Weight	baseline and 36 months	Subjects calculated weight in kilograms

Secondary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	baseline and 36 months	Systolic blood pressure (top number of blood pressure reading)
Diastolic Blood Pressure	baseline and 36 months	Diastolic blood pressure (bottom number of blood pressure reading)
Low-density Lipoprotein (LDL)	baseline and 36 months	LDL's carry cholesterol through the bloodstream. LDL is called bad cholesterol because high amounts can form plaques in the blood vessels, increasing risk for heart disease. Adult normal range is less than 100 mg/dL.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States