Exendin-9,39 and Satiety After Bariatric Surgery

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Drug: Saline; Drug: Exendin-9,39

• Registration Number: NCT02779075
• Lead Sponsor: Mayo Clinic

Brief Summary

The overall aim of the application is to determine the contribution of the elevated incretin hormone concentrations seen after certain types of bariatric surgery to the regulation of food intake and satiety.

Detailed Description

Both Sleeve Gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGB) increase GLP-1 concentrations, although this is of lesser magnitude in SG compared to RYGB. Data suggests that endogenous GLP-1 is at least partially responsible for reducing free-choice caloric intake after RYGB, providing a mechanism underlying differences between procedures. Inhibition of GLP-1 action with Exendin-9,39 after RYGB accelerates gastric emptying. These observations suggest that factors other than anatomy regulate the upper gastrointestinal response to food ingestion. It is therefore reasonable to consider 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.

Study Timeline

• Study First Submitted: 2016-05-16
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-20
• Study Start: 2016-06
• Primary Completion: 2019-07
• Study Completion: 2019-12
• Status Verified: 2020-04
• Results First Submitted: 2020-04-09
• Results First Submitted QC: 2020-04-22
• Last Update Submitted: 2020-04-22
• Results First Posted: 2020-05-01
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Undergone either sleeve gastrectomy or Roux-en-Y Gastric Bypass surgery within prior 2 years
• Healthy, with no active systemic illness

Exclusion Criteria

• Pregnancy
• Functional or organic bowel symptoms
• Systemic illness
• Diabetes
• Bariatric surgery > 2 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline	Saline	0.9% NaCL (saline) intravenously for 6 hours.
Exendin-9,39	Exendin-9,39	Exendin-9,39 intravenously for 6 hours.

Primary Outcome Measures

Name	Time	Method
Caloric Intake	5 hours	caloric intake from a free choice buffet within 5 hours after ingestion of a standard meal

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal Transit Measured Using Scintigraphy	4 hours	Time taken to empty 50% of stomach contents (GE50) measured using scintigraphy over the 4 hours after ingestion of a labeled meal

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States