Phase 3
N=46
Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03115424 ↗Enrolled (actual)
46
Serious AEs
2.2%
Results posted
Sep 2024
Primary outcome: Primary: Weight — 127; 130; 126; 75 kilograms
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Saxenda (Drug); Placebos (Drug); RYGB (Procedure)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight |
127; 130; 126; 75; 107; 98 | — |
| SECONDARY Systolic Blood Pressure |
129; 130; 123; 112; 128; 122 | — |
| SECONDARY Diastolic Blood Pressure |
86; 83; 76; 84; 93; 82 | — |
| SECONDARY Low-density Lipoprotein (LDL) |
114; 101; 99; 106; 68; 90 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 20-65 years of age
- Seen at Mayo Clinic Nutrition Clinic and have received authorization for bariatric surgery.
- No active physical illness which will interfere with mobility or weight loss after bariatric surgery.
- 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
- Prior use of glucose lowering medication in the 3 months prior to screening.
- 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.
- Prior abdominal surgery other than cholecystectomy, appendectomy or hysterectomy.
- Pregnancy or active consideration of pregnancy during the period of study. Subjects will be discontinued if they become pregnant during the study.
- Hypersensitivity to liraglutide or any product components.
- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2.
- Prior history of pancreatitis, cholelithiasis or cholecystitis.
- Concurrent use of insulin or any other GLP-1 receptor agonist.
- Active, severe psychiatric disease
Data sourced from ClinicalTrials.gov (NCT03115424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.