Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass

Post-bariatric Surgery Clinical Trial

— GLP-1  

Official title:

The Role of Glucagon Like Peptide-1 in Glucose Metabolism and Weight Loss Following Gastric Bypass Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01803451
• Other study ID #: HSC20180070H
• Secondary ID: DK083554
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 2005
• Est. completion date: August 2026

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Marzieh Salehi, MD MS
• Phone: 210-567-6691
• Email: salehi[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism.

The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims.

1. To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp.

2. To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.

3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.

Description:

The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism.

The central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims.

1. To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp.

2. To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.

3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65

• healthy control without diabetes or active organ disease

• Individuals with bariatric surgery

• recurrent hypoglycemia post gastric bypass

Exclusion Criteria:

• pregnancy

• significant anemia

• diabetes currently unless pre-op for bariatric surgery procedure

• GI obstruction

Related Conditions & MeSH terms

• Post-bariatric Surgery

Intervention

Drug:
• exendin-(9-39)
hyperglycemic clamp-meal tolerance test is designed to assess insulin secretion before and after meal ingestion
• exendin -(9-39)
2-day meal tolerance tests with labeled oral and IV glucose using exendin-(9-39) infusion are designed to evaluate the role of GLP-1 signaling on glucose tolerance and glucose kinetics.

Locations

Country	Name	City	State
United States	South Texas Veterans Health Care System	San Antonio	Texas
United States	Texas Diabetes Institute - University Health System	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The investigator measure glucose, islet and GI hormonal levels in response to meal ingestion as a composite measure and the percentage of contribution of GLP-1 contribution to postprandial insulin levels will also be calculated		up to 1 year (10 sessions)