Sponsor study identifier
Secondary identifiers
NIH
interventional
13
1 country
1
Study Start
July 2014
Actual (reported)Primary Completion
November 17, 2015
Actual (reported)Study Completion
November 17, 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 17, 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2014
Actual (reported)July 28, 2014
Actual (reported)July 30, 2014
Actual (reported)November 17, 2015
Actual (reported)November 17, 2015
Actual (reported)Insulin secretion rates (ISRs) during each treatment
ISRs will be measured at various times before and after ingestion of a liquid mixed meal.
5.5 hours
Plasma glucose levels during each treatment.
5.5 hours
Plasma glucagon levels during each treatment.
5.5 hours
Healthy, weight stable individuals, with previous Roux-en-Y gastric bypass surgery. No clinical evidence of type 2 diabetes before and after surgery. Each participant will receive placebo or the indicated doses of xenin-25.
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.
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.
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Sterl K, Wang S, Oestricker L, Wallendorf MJ, Patterson BW, Reeds DN, Wice BM. Metabolic responses to xenin-25 are altered in humans with Roux-en-Y gastric bypass surgery. Peptides. 2016 Aug;82:76-84. doi: 10.1016/j.peptides.2016.06.001. Epub 2016 Jun 7.
Burton M Wice, PhD
Washington University School of Medicine
Dominic Reeds, MD
Washington University School of Medicine
13 participants (actual enrollment reported by the registry).
First Submitted
July 28, 2014
First Posted
July 30, 2014
Study Start
July 2014
Actual (reported)Pharmacokinetics of Rivaroxaban After Bariatric Surgery
Plasma GLP-1 during each treatment.
5.5 hours
Plasma C-peptide levels during each treatment.
5.5 hours
The rate of gastric emptying during each treatment.
5.5 hours
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
November 17, 2015
Actual (reported)Study Completion
November 17, 2015
Actual (reported)Last Updated
April 27, 2018
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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