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Completed

NCT Number: NCT03442972

Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids

Some of the fat (triglyceride) from the food humans eat gets stored in the bowel. This triglyceride can then be released into the blood when another meal is consumed or in response to hormones. How the gut hormone glucagon-like peptide-2 (GLP-2) releases the triglyceride from the gut is not known. The research team in this study is interested in finding out how teduglutide (a degradation resistant form of GLP-2) releases stored triglyceride from the gut by studying samples from patients undergoing endoscopy and small bowel biopsy.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Kensington Screening Clinic, Toronto, Ontario, Canada

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About this study

The release of stored enteral lipids will be investigated in 30 patients undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical indications. Patients undergoing the procedure will be recruited. Participants will have a high fat liquid meal as breakfast. 5 hours later, participants will be randomly assigned to receive either a subcutaneous injection of placebo (n=15) or a subcutaneous injection of the Health Canada approved glucagon-like peptide-2 (GLP-2) analogue (teduglutide, Revestive®, Shire Canada)(n=15 different subjects). 1 hour later, a duodenal biopsy specimen will be obtained from 2-3 sample sites,snap frozen in dry ice and stored at -80°C for further analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by Dr. Bookman of the Kensington Screening Clinic, Toronto, ON, Canada

Exclusion criteria

  • Patients with active inflammatory bowel disease
  • Patients with pre-existing Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption
  • Patients with active bowel malignancy
  • Patients with diabetes mellitus or known/ suspected motility disorders of the gut
  • Patients with decompensated liver disease
  • Patients on ezetimibe or bile acid sequestrants
  • Patients who are pregnant or breastfeeding.
  • Patients with renal disease
  • Patients on benzodiazepine
  • Unstable cardiac or respiratory disease
  • Any changes to medication in the preceding month

Treatment and study plan

Teduglutide

Drug

Teduglutide

Placebo

Drug

Placebo

Primary outcomes

  1. Release of enteral lipids in response to teduglutide

    Time frame: 6 hours

    To quantify the difference in amount of enteral lipids between GLP-2 and placebo treatment

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Kensington Screening Clinic

Registry information

Official study title

Investigating the Release of Stored Enteral Lipids in Response to a Single Subcutaneous Dose of Analogue Glucagon-like Peptide-2 in Humans

Acronym: GLP-2 Biopsy

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 22, 2018
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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