DRUG
TED + glucose
Teduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose
Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins
Status
Unknown
Phase
Phase 2 / Phase 3
Enrollment
15
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Mar 4, 2019
Study start
May 1, 2019
Primary completion
Dec 1, 2021
Study completion
May 2022
Results posted
Not reported
Registry updated
Apr 29, 2021
Outcomes
What the study measures.
Primary outcomes
Lipoprotein response to teduglutide and glucose
Time frame · 8 hours
To quantify the plasma lipoprotein response to teduglutide (GLP-2 analogue) injection and oral glucose in healthy individuals
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 60 Years
- Sex
- ALL
- 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)
Study locations
1 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
Tornto General Hospital, UHN
Toronto, Ontario, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.