DRUG
Teduglutide
Teduglutide
Plasma Lipoprotein Response to Glucagon-like Peptide-2
Status
Completed
Phase
Phase 2 / Phase 3
Enrollment
10
Locations
1
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 evaluating how blood lipoproteins respond to teduglutide in healthy individuals.
Full detailed description
The lipoprotein response will be performed in 15 healthy individuals recruited by newspaper advertisements. Each subject will be their own control, receiving both placebo and teduglutide, administered on separate occasions. A member of the study team will explain the study in detail on visit 1, and if the individual is interested in participating, informed consent will be obtained and preliminary screening will occur on visit 2. On visit 3 \& 4 participants will receive a high fat liquid meal after an overnight fast. Hourly blood samples will be taken for 5 hours, followed by randomized assignment to receive either subcutaneous placebo or teduglutide at visit 3 and the opposite treatment at visit 4. Following the injection, blood samples will be taken every 15 minutes for the first hour and every 30 minutes for the subsequent 3 hours.
Interventions
Treatment arms and agents.
DRUG
Placebo
Placebo
Timeline
From registration to results.
First posted
Feb 6, 2018
Study start
Sep 21, 2018
Primary completion
Jun 1, 2021
Study completion
Dec 1, 2021
Results posted
Not reported
Registry updated
Jun 14, 2022
Outcomes
What the study measures.
Primary outcomes
Lipoprotein response to teduglutide
Time frame · 8 hours
To quantify the plasma lipoprotein response to teduglutide (GLP-2 analogue) injection in healthy individuals
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
- Yes
Inclusion Criteria: * Men and women, aged 18 to 60 years. * Body mass index 20 to 27 kg/m2 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
1 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
Toronto General Hopital
Toronto, Ontario, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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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.