NCT02204813

To Define the Role of GLP-1 for Improving Glucose Homeostasis in Humans Following Gastric Bypass Surgery

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

There is a marked and long-lasting improvement in glucose homeostasis that follows Roux-en-y gastric bypass surgery (RYGB) in humans. This improvement has been attributed in large part to an intestinal hormone, called GLP-1, that is released into the circulation immediately after eating. The purpose of this study is to determine if GLP-1 mediates the beneficial effects of RYGB surgery on glucose homeostasis in humans.

Detailed description

To conduct this study, we will enroll humans who previously underwent Roux-en-Y gastric bypass surgery, who are medically and weight stable and with no signs of type 2 diabetes either before or after surgery. Potential subjects will first be screened for eligibility and also to verify that they can safely participate in the study. Each study subject will be administered a meal tolerance test (MTT) on 3 separate occasions. For the MTT, a liquid meal (Boost Plus) will be ingested following an overnight fast. A primed-continuous infusion of vehicle alone (human albumin) or xenin-25 alone (at a dose of 4 or 12 pmoles x kg-1 x min-1) will be initiated 15 minutes before the meal is ingested. Blood samples will be collected before and during the MTT for the measurement of glucose and insulin levels, as well as a host of other hormones. A comparison of the results will tell us if the effects of xenin-25 on insulin release are mediated by GLP-1 in humans.

Conditions

• Bypass, Gastric
• Roux-en-Y Gastric Bypass
• Vertical Sleeve Gastrectomy
• Gastric Banding
• Bariatric Surgery

Interventions

Type	Name	Description
DRUG	Placebo	A liquid mixed meal containing 1.5 grams of acetaminophen will be ingested in 7 equal portions from 0-30 minutes. Starting at minus 15 minutes, an intravenous infusion of albumin alone (placebo) will be administered for 5.25 hours.
DRUG	Lo-Xenin	A liquid mixed meal containing 1.5 grams of acetaminophen will be ingested in 7 equal portions from 0-30 minutes. Starting at minus 15 minutes, an intravenous infusion of xenin-25 at a dose of 4 pmoles/kg/min will be administered for 5.25 hours.
DRUG	Hi-Xenin	A liquid mixed meal containing 1.5 grams of acetaminophen will be ingested in 7 equal portions from 0-30 minutes. Starting at minus 15 minutes, an intravenous infusion of xenin-25 at a dose of 12 pmoles/kg/min will be administered for 5.25 hours.
DRUG	Extra Hi-Xenin	A liquid mixed meal containing 1.5 grams of acetaminophen will be ingested in 7 equal portions from 0-30 minutes. Starting at minus 15 minutes, an intravenous infusion of xenin-25 at a dose of 24 pmoles/kg/min will be administered for 5.25 hours.

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-11-17
• Completion: 2015-11-17
• First posted: 2014-07-30
• Last updated: 2018-04-27

Locations

1 site across 1 country: United States