Plasma Lipoprotein Response to Glucagon-like Peptide-2 (GLP-2 Plasma)

June 13, 2022 updated by: University Health Network, Toronto

Investigating the Plasma Lipoprotein Response to a Single Subcutaneous Dose of Analogue Glucagon-like Peptide-2 in Humans

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) releases 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) releases stored triglyceride from the gut by evaluating how blood lipoproteins respond to teduglutide in healthy individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The lipoprotein response will be performed in 15 healthy individuals recruited by newspaper advertisements. Each subject will be their own control, receiving both placebo and teduglutide, administered on separate occasions. 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. On visit 3 & 4 participants will receive a high fat liquid meal after an overnight fast. Hourly blood samples will be taken for 5 hours, followed by randomized assignment to receive either subcutaneous placebo or teduglutide at visit 3 and the opposite treatment at visit 4. Following the injection, blood samples will be taken every 15 minutes for the first hour and every 30 minutes for the subsequent 3 hours.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hopital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teduglutide
Teduglutide, up to 0.05mg/kg, subcutaneous, single dose
Drug: Teduglutide
Teduglutide
Placebo Comparator: Placebo
Placebo, subcutaneous, single dose
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipoprotein response to teduglutide
Time Frame: 8 hours
To quantify the plasma lipoprotein response to teduglutide (GLP-2 analogue) injection in healthy individuals
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Gary Lewis, MD, UHN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2018

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

January 30, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-6368.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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