Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins

NCT ID: NCT03860688

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2022-05-31

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.

Conditions

Hyperlipidemias

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Teduglutide + glucose

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

Group Type: EXPERIMENTAL

TED + glucose

Intervention Type: DRUG

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

Interventions

TED + glucose

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tornto General Hospital, UHN

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Brenda Hughes, RN

Role: CONTACT

brenda.hughes@uhn.ca

416-340-4800 ext. 8886

Gary Lewis, MD

Role: CONTACT

gary.lewis@uhn.ca

416-340-4270

Facility Contacts

Brenda Hughes, RN

Role: primary

brenda.hughes@uhn.ca

416-340-8886

Other Identifiers

TED+GLC plasma 18-6296

Identifier Type: -

Identifier Source: org_study_id