Primary outcomeMean· baseline and 36 months
Weight
| Group | Value (kilograms) | Spread |
|---|---|---|
| Sleeve Gastrectomy Saxenda | 127 | 7 |
| Sleeve Gastrectomy Placebo | 130 | 8 |
| Roux-en-Y Gastric (RYGB) | 126 | 4 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataEffect of GLP-1 Receptor Agonism After Sleeve Gastrectomy
NCTNCT03115424 (opens ClinicalTrials.gov in a new tab)Other id16-004253
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 46 participants (actual)
- Sponsor
- Mayo Clinic · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 22 Jun 2017
- Primary completion
- 4 Oct 2023
- Completion
- 30 May 2024
- First posted
- 14 Apr 2017
- Last update posted
- 27 Sept 2024
- Conditions
- Obesity
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2018202020222024
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- SaxendaDrug
- PlacebosDrug
- RYGBProcedure
Arms3
Placebo comparator
Sleeve Gastrectomy Placebo
Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.
Active comparator
Sleeve Gastrectomy Saxenda
Subjects undergoing Sleeve Gastrectomy (SG) will be randomized 1:1 at the time of 3 month visit after bariatric surgery.
Sham comparator
RYGB
Twenty five subjects will be recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery.
Primary outcomes1
Outcomes the sponsor listed as primary.
Weight
Time frame · baseline and 36 months
Registry description
Subjects calculated weight in kilograms
Secondary outcomes(3)
Systolic Blood Pressure
Time frame · baseline and 36 months
Registry description
Systolic blood pressure (top number of blood pressure reading)
Diastolic Blood Pressure
Time frame · baseline and 36 months
Registry description
Diastolic blood pressure (bottom number of blood pressure reading)
Low-density Lipoprotein (LDL)
Time frame · baseline and 36 months
Registry description
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.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(3)
Secondary outcomeMean· baseline and 36 months
Systolic Blood Pressure
| Group | Value (Millimeters of Mercury) | Spread |
|---|---|---|
| Sleeve Gastrectomy Saxenda | 129 | 4 |
| Sleeve Gastrectomy Placebo | 130 | 7 |
| Roux-en-Y Gastric (RYGB) | 123 | 4 |
Secondary outcomeMean· baseline and 36 months
Diastolic Blood Pressure
| Group | Value (Millimeters of Mercury) | Spread |
|---|---|---|
| Sleeve Gastrectomy Saxenda | 86 | 3 |
| Sleeve Gastrectomy Placebo | 83 | 6 |
| Roux-en-Y Gastric (RYGB) | 76 | 2 |
Secondary outcomeMean· baseline and 36 months
Low-density Lipoprotein (LDL)
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Sleeve Gastrectomy Saxenda | 114 | 9 |
| Sleeve Gastrectomy Placebo | 101 | 11 |
| Roux-en-Y Gastric (RYGB) | 99 | 5 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Sleeve Gastrectomy SaxendaSubjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery. Saxenda: Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will were randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. | 0 / 12 | 1 / 12 | 2 / 12 |
| Sleeve Gastrectomy PlaceboSubjects underwent Sleeve Gastrectomy (SG) were randomized 1:1 at the time of 3 month visit after bariatric surgery. Placebos: Subjects were recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG were randomized 1:1 at months 3 post-surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects remained on study drug for duration of study. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. | 0 / 9 | 0 / 9 | 1 / 9 |
| Roux-en-Y Gastric (RYGB)Subjects were recruited from the Nutrition Clinic at Mayo Clinic Rochester prior to undergoing RYGB surgery. RYGB: Subjects were recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits were timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36. | 0 / 25 | 0 / 25 | 14 / 25 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 20 Years up to 65 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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
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