Exendin-9,39 and Satiety After Bariatric Surgery

Obesity Clinical Trial

Official title:

Exendin-9,39 and Satiety After Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02779075
• Other study ID #: 16-001973
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Saline
Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline.
• Exendin-9,39
Subjects will be studied on 2 occasions, in random order. During the Exendin-9,39 study day they will be infused with Exendin-9,39. Exendin-9,39 blocks the actions of specific hormones called incretins, that are produced in the gut in health and in larger quantities after gastric bypass surgery.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	The Obesity Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caloric Intake	caloric intake from a free choice buffet within 5 hours after ingestion of a standard meal	5 hours
Secondary	Gastrointestinal Transit Measured Using Scintigraphy	Time taken to empty 50% of stomach contents (GE50) measured using scintigraphy over the 4 hours after ingestion of a labeled meal	4 hours