NCT03115424CompletedPhase 3
Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy
Effect of GLP-1 Receptor Agonism on Weight and Caloric Intake in Subjects After Sleeve Gastrectomy
Source: ClinicalTrials.gov · Last updated 27 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 46 (actual)
- First submitted
- 5 Apr 2017
- Start date
- 22 Jun 2017
- Primary completion date
- 4 Oct 2023
- Lead sponsor
- Mayo Clinic
- Diseases
- Obesity
- NCT number
- NCT03115424
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 46
- From 22 Jun 2017 to the primary completion date, 4 Oct 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior abdominal surgery other than cholecystectomy, appendectomy or hysterectomy.
- Prior history of pancreatitis, cholelithiasis or cholecystitis.
- Concurrent use of insulin or any other GLP-1 receptor agonist.
Other illness
- Hypersensitivity to liraglutide or any product components.
- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2.
- Active, severe psychiatric disease
Lab values
- 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.
Other
- Pregnancy or active consideration of pregnancy during the period of study. Subjects will be discontinued if they become pregnant during the study.
Who the study is looking for
- 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.
Age in the registry: 20 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.