Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins

Hyperlipidemias Clinical Trial

— TED+GLC plasma  

Official title:

Investigating the Plasma Lipoprotein Response to a Single Subcutaneous Injection of Analogue Glucagon-like Peptide-2 and Oral Glucose in Humans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03860688
• Other study ID #: TED+GLC plasma 18-6296
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 1, 2019
• Est. completion date: May 2022

Study information

• Verified date: April 2021
• Source: University Health Network, Toronto
• Contact: Brenda Hughes, RN
• Phone: 416-340-4800
• Email: brenda.hughes[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

Drug:
• TED + glucose
Teduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose

Locations

Country	Name	City	State
Canada	Tornto General Hospital, UHN	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipoprotein response to teduglutide and glucose	To quantify the plasma lipoprotein response to teduglutide (GLP-2 analogue) injection and oral glucose in healthy individuals	8 hours