Clinical trial NCT03860688: Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins
Official title: Investigating the Plasma Lipoprotein Response to a Single Subcutaneous Injection of Analogue Glucagon-like Peptide-2 and Oral Glucose in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hyperlipidemias
Keywords: Intestinal lipoprotein
Gut peptide
Chylomicrons
Glucose
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: On visit 2, participants will receive teduglutide and glucose 5 hours after a liquid meal
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Lipoprotein response to teduglutide and glucose
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Tornto General Hospital, UHN
state: Ontario
Study officials:
References: