DRUG
Teduglutide
Teduglutide
Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids
Status
Completed
Phase
Phase 2 / Phase 3
Enrollment
21
Locations
2
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full detailed description
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
Placebo
Timeline
From registration to results.
First posted
Feb 22, 2018
Study start
Jan 17, 2019
Primary completion
Jun 1, 2021
Study completion
Dec 1, 2021
Results posted
Not reported
Registry updated
May 25, 2022
Outcomes
What the study measures.
Primary outcomes
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
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
2 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
Toronto General Hopital
Toronto, Ontario, Canada
Kensington Screening Clinic
Toronto, Ontario, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Teduglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.