Exendin-9,39 and Satiety After Bariatric Surgery

NCT ID: NCT02779075

Last Updated: 2020-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-12-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Saline

0.9% NaCL (saline) intravenously for 6 hours.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline.

Exendin-9,39

Exendin-9,39 intravenously for 6 hours.

Group Type: ACTIVE_COMPARATOR

Exendin-9,39

Intervention Type: DRUG

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.

Interventions

Saline

Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Obesity Society

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Adrian Vella

MD, FRCP (Edin), Consultant Division or Endocrinolgy, Diabetes and Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adrian Vella

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

Kittah E, Camilleri M, Jensen MD, Vella A. A Pilot Study Examining the Effects of GLP-1 Receptor Blockade Using Exendin-(9,39) on Gastric Emptying and Caloric Intake in Subjects With and Without Bariatric Surgery. Metab Syndr Relat Disord. 2020 Nov;18(9):406-412. doi: 10.1089/met.2020.0049. Epub 2020 Aug 20.

Reference Type: DERIVED

PMID: 32833560 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-001973

Identifier Type: -

Identifier Source: org_study_id