Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins (TED+GLC plasma)

University Health Network, Toronto

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hyperlipidemias

Treatments: Drug: TED + glucose

Study type: Interventional

Funder types: Other

Identifiers

NCT03860688

TED+GLC plasma 18-6296

Details and patient eligibility

About

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 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Teduglutide + glucose

Experimental group

Description:

Teduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose

Treatment:

Drug: TED + glucose