Primary outcome
What NCT03115424 measured first
| Measure | Sleeve Gastrectomy Saxendan=12 | Sleeve Gastrectomy Placebon=9 | Roux-en-Y Gastric (RYGB)n=25 |
|---|---|---|---|
| baseline | 127(7) | 130(8) | 126(4) |
| 36 months | 75(8) | 107(10) | 98(7) |
Phase 3 · Liraglutide
NCT03115424 trial results
Effect of GLP-1 Receptor Agonism on Weight and Caloric Intake in Subjects After Sleeve Gastrectomy
- Participants
- 46
- Status
- completed
- Completed
- 2024-05-30
- Sponsor
- Mayo Clinic
As posted on ClinicalTrials.gov (NCT03115424), updated at source Sep 27, 2024. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT03115424
Percent of participants affected, Adverse Events were collected from baseline to end of study, approximately 36 months. The most common events the registry lists.
| Event | Sleeve Gastrectomy Saxenda | Sleeve Gastrectomy Placebo | Roux-en-Y Gastric (RYGB) |
|---|---|---|---|
| Any serious event | 8.3% | 0% | 0% |
| Nausea | 16.7% | 11.1% | 56% |
| Vomiting | 16.7% | 11.1% | 52% |
| Hgb < 11.5 g/dL | 0% | 0% | 4% |
Secondary outcomes
What else it measured
| Measure | Sleeve Gastrectomy Saxendan=12 | Sleeve Gastrectomy Placebon=9 | Roux-en-Y Gastric (RYGB)n=25 |
|---|---|---|---|
| baseline | 129(4) | 130(7) | 123(4) |
| 36 months | 112(7) | 128(1) | 122(7) |
| Measure | Sleeve Gastrectomy Saxendan=12 | Sleeve Gastrectomy Placebon=9 | Roux-en-Y Gastric (RYGB)n=25 |
|---|---|---|---|
| baseline | 86(3) | 83(6) | 76(2) |
| 36 months | 84(4) | 93(13) | 82(3) |
| Measure | Sleeve Gastrectomy Saxendan=12 | Sleeve Gastrectomy Placebon=9 | Roux-en-Y Gastric (RYGB)n=25 |
|---|---|---|---|
| baseline | 114(9) | 101(11) | 99(5) |
| 36 months | 106(20) | 68(1) | 90(7) |
The trial
How NCT03115424 was run
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.
- Sleeve Gastrectomy Placebo: Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.
- Sleeve Gastrectomy Saxenda: Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.
- RYGB: Twenty five subjects will be recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.
Who could join the trial
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
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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