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Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass

NCT01803451 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-09

No results posted yet for this study

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.

Conditions

  • Post-bariatric Surgery

Interventions

DRUG

exendin-(9-39)

hyperglycemic clamp-meal tolerance test is designed to assess insulin secretion before and after meal ingestion

DRUG

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Marzieh Salehi, MD,MS · Marzieh Salehi

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2026-08-31
Completion
2027-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01803451 on ClinicalTrials.gov