Hyperlipidemias
Conditions
Keywords
Intestinal lipoprotein, Gut peptide, Chylomicrons, Glucose
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) 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.
Interventions
DRUGTED + glucose
Teduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
On visit 2, participants will receive teduglutide and glucose 5 hours after a liquid meal
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
1. Patients with active inflammatory bowel disease 2. Patients with pre-existing Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption 3. Patients with active bowel malignancy 4. Patients with diabetes mellitus or known/ suspected motility disorders of the gut 5. Patients with decompensated liver disease 6. Patients on ezetimibe or bile acid sequestrants 7. Patients who are pregnant or breastfeeding. 8. Patients with renal disease. 9. Patients on benzodiazepine. 10. Unstable cardiac or respiratory disease 11. Any changes to medication in the preceding month 12. Patients with hypersensitive to Revestive or any ingredient, active or a history of the drug within the last 5 years 13. Patients with GI malignancy (GI tract, hepatobiliary, pancreatic)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipoprotein response to teduglutide and glucose | 8 hours | To quantify the plasma lipoprotein response to teduglutide (GLP-2 analogue) injection and oral glucose in healthy individuals |
Countries
Canada
Contacts
Primary ContactBrenda Hughes, RN
Backup ContactGary Lewis, MD
Outcome results
None listed