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Recruiting NCT01803451

Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass

Early Phase I Interventional Post-bariatric Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: exendin-(9-39), exendin -(9-39).
Who it may be relevant to
Registry conditions: Post-bariatric Surgery. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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.

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.

Primary outcome measures

  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Factorial
Masking
Single blind
Primary purpose
Other

Study locations

United States · 2 centers
  • Texas Diabetes Institute - University Health System — San Antonio
  • South Texas Veterans Health Care System — San Antonio

Publications

  • Salehi M, Gastaldelli A, D'Alessio DA. Blockade of glucagon-like peptide 1 receptor corrects postprandial hypoglycemia after gastric bypass. Gastroenterology. 2014 Mar;146(3):669-680.e2. doi: 10.1053/j.gastro.2013.11.044. Epub 2013 Dec 4. PMID 24315990

Identifiers

NCT: NCT01803451 · HSC20180070H · DK083554

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗