Hyperlipidemias
Conditions
Keywords
Intestinal lipoprotein, Gut Peptide, Chylomicrons
Brief 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.
Interventions
DRUGTeduglutide
Teduglutide
DRUGPlacebo
Placebo
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Masking description
Single-blinded study with participant blinded to treatment
Intervention model description
On visits 3 & 4, participants will receive either teduglutide or placebo, in random order, 5 hours after a high-fat drink
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipoprotein response to teduglutide | 8 hours | To quantify the plasma lipoprotein response to teduglutide (GLP-2 analogue) injection in healthy individuals |
Countries
Canada
Outcome results
None listed