Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass

Conditions

• Post-bariatric Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• exendin-(9-39) — DRUG
  hyperglycemic clamp-meal tolerance test is designed to assess insulin secretion before and after meal ingestion
• exendin -(9-39) — DRUG
  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.

Study Details

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.

Key Dates

Start date

Nov 30, 2005

Status verified

Sep 2025

Primary completion

Aug 31, 2026

Completion

Aug 31, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

OTHER

Arms

• Experimental: hyperglycemic clamp-Meal tolerance test
  these studies are to evaluate the effect of exendin-9 on insulin secretion before and after meal ingestion in patients after bariatric surgeries compared to non-surgical controls
• Experimental: Labeled meal tolerance test
  The effect of GLP-1 receptor blockade on glucose tolerance and glucose kinetics are evaluated in the group patients with bariatric surgery vs. nonsurgical using exendin-9-39 infusion during one of the the 2-day dual tracer studies of meal tolerance test

Primary Outcome Measure

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 [ Time Frame: up to 1 year (10 sessions) ]

Central Contacts

• Marzieh Salehi, MD MS
  210-567-6691
  [email protected]
• Jennifer Foster, MSN
  210-450-8696
  [email protected]

Locations (2)

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