Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy
Status: | Recruiting |
---|---|
Conditions: | Obesity Weight Loss |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 20 - 65 |
Updated: | 8/12/2018 |
Start Date: | June 22, 2017 |
End Date: | December 2020 |
Contact: | Paula D Giesler, RN, BSN, CDE |
Email: | giesler.paula@mayo.edu |
Phone: | 507-255-8345 |
Effect of GLP-1 Receptor Agonism on Weight and Caloric Intake in Subjects After Sleeve Gastrectomy
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.
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.
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.
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.
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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