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OpenTrials
Completed

NCT Number: NCT03422666

Plasma Lipoprotein Response to Glucagon-like Peptide-2

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.

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Key information

Conditions

Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Toronto General Hopital

Toronto, Ontario, M5G 2C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teduglutide

Drug

Teduglutide

Placebo

Drug

Placebo

Primary outcomes

  1. Lipoprotein response to teduglutide

    Time frame: 8 hours

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: GLP-2 Plasma

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2018
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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