Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins

Phase 2

• Conditions: Hyperlipidemias
• Interventions: Drug: TED + glucose

• Registration Number: NCT03860688
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2019-02-28
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-04
• Study Start: 2019-05-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29
• Primary Completion: 2021-12-01
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Men and women, aged 18 to 60 years.
• Body mass index 20 to 27 kg/m2

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teduglutide + glucose	TED + glucose	Teduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tornto General Hospital, UHN; 🇨🇦 Toronto, Ontario, Canada