Plasma Lipoprotein Response to Glucagon-like Peptide-2 (GLP-2 Plasma)

University Health Network, Toronto

Status and phase

Completed

Phase 3

Phase 2

Conditions

Hyperlipidemias

Treatments

Drug: Teduglutide

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03422666

16-6368.1

Details and patient eligibility

About

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 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.

Enrollment

10 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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