NCT03422666

Plasma Lipoprotein Response to Glucagon-like Peptide-2

Investigating the Plasma Lipoprotein Response to a Single Subcutaneous Dose of Analogue Glucagon-like Peptide-2 in Humans

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Hyperlipidemias

Interventions

Type	Name	Description
DRUG	Teduglutide	Teduglutide
DRUG	Placebo	Placebo

Timeline

• Start date: 2018-09-21
• Primary completion: 2021-06-01
• Completion: 2021-12-01
• First posted: 2018-02-06
• Last updated: 2022-06-14

Locations

1 site across 1 country: Canada