NCT03860688

Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins

Investigating the Plasma Lipoprotein Response to a Single Subcutaneous Injection of Analogue Glucagon-like Peptide-2 and Oral Glucose in Humans

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 15 (estimated)
• 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) and glucose release 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) ang glucose, given together, release 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. 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 participants will receive a high fat liquid meal after an overnight fast. Hourly blood samples will be taken for 5 hours, followed by a subcutaneous teduglutide injection and simultaneous glucose drink. Following the injection and drink, 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	TED + glucose	Teduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-12-01
• Completion: 2022-05-01
• First posted: 2019-03-04
• Last updated: 2021-04-29

Locations

1 site across 1 country: Canada