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

Primary Purpose

Hyperlipidemias

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

TED + glucose

About this trial

This is an interventional basic science trial for Hyperlipidemias focused on measuring Intestinal lipoprotein, Gut peptide, Chylomicrons, Glucose

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Patients with active inflammatory bowel disease
Patients with pre-existing Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption
Patients with active bowel malignancy
Patients with diabetes mellitus or known/ suspected motility disorders of the gut
Patients with decompensated liver disease
Patients on ezetimibe or bile acid sequestrants
Patients who are pregnant or breastfeeding.
Patients with renal disease.
Patients on benzodiazepine.
Unstable cardiac or respiratory disease
Any changes to medication in the preceding month
Patients with hypersensitive to Revestive or any ingredient, active or a history of the drug within the last 5 years
Patients with GI malignancy (GI tract, hepatobiliary, pancreatic)

Sites / Locations

Tornto General Hospital, UHNRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Teduglutide + glucose

Arm Description

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

Outcomes

Primary Outcome Measures

Lipoprotein response to teduglutide and glucose

To quantify the plasma lipoprotein response to teduglutide (GLP-2 analogue) injection and oral glucose in healthy individuals

Secondary Outcome Measures

Full Information

NCT ID

NCT03860688

First Posted

February 28, 2019

Last Updated

April 28, 2021

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT03860688

Brief Title

Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

December 1, 2021 (Anticipated)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemias

Keywords

Intestinal lipoprotein, Gut peptide, Chylomicrons, Glucose

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Model Description

On visit 2, participants will receive teduglutide and glucose 5 hours after a liquid meal

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Teduglutide + glucose

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

TED + glucose

Intervention Description

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

Primary Outcome Measure Information:

Title

Lipoprotein response to teduglutide and glucose

Description

To quantify the plasma lipoprotein response to teduglutide (GLP-2 analogue) injection and oral glucose in healthy individuals

Time Frame

8 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women, aged 18 to 60 years. Body mass index 20 to 27 kg/m2 Exclusion Criteria: Patients with active inflammatory bowel disease Patients with pre-existing Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption Patients with active bowel malignancy Patients with diabetes mellitus or known/ suspected motility disorders of the gut Patients with decompensated liver disease Patients on ezetimibe or bile acid sequestrants Patients who are pregnant or breastfeeding. Patients with renal disease. Patients on benzodiazepine. Unstable cardiac or respiratory disease Any changes to medication in the preceding month Patients with hypersensitive to Revestive or any ingredient, active or a history of the drug within the last 5 years Patients with GI malignancy (GI tract, hepatobiliary, pancreatic)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brenda Hughes, RN

Phone

416-340-4800

Ext

8886

brenda.hughes@uhn.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Gary Lewis, MD

Phone

416-340-4270

gary.lewis@uhn.ca

Facility Information:

Facility Name

Tornto General Hospital, UHN

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1L7

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brenda Hughes, RN

Phone

416-340-8886

brenda.hughes@uhn.ca

First Name & Middle Initial & Last Name & Degree

Gary F Lewis, MD

12. IPD Sharing Statement

Plan to Share IPD

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Effects of Oral Glucose and Teduglutide on Plasma Lipoproteins

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