Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids (GLP-2 Biopsy)

Investigating the Release of Stored Enteral Lipids in 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 studying samples from patients undergoing endoscopy and small bowel biopsy.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemias
• Intervention / Treatment: Drug: Placebo; Drug: Teduglutide

Detailed Description

The release of stored enteral lipids will be investigated in 30 patients undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical indications. Patients undergoing the procedure will be recruited. Participants will have a high fat liquid meal as breakfast. 5 hours later, participants will be randomly assigned to receive either a subcutaneous injection of placebo (n=15) or a subcutaneous injection of the Health Canada approved glucagon-like peptide-2 (GLP-2) analogue (teduglutide, Revestive®, Shire Canada)(n=15 different subjects). 1 hour later, a duodenal biopsy specimen will be obtained from 2-3 sample sites,snap frozen in dry ice and stored at -80°C for further analysis.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hopital
    • Toronto, Ontario, Canada, M5T 3A9
      • Kensington Screening Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by Dr. Bookman of the Kensington Screening Clinic, Toronto, ON, Canada

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

How is the study designed?

Design Details

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

Number of Arms

2

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
Release of enteral lipids in response to teduglutide	To quantify the difference in amount of enteral lipids between GLP-2 and placebo treatment	6 hours

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Kensington Screening Clinic
• Investigators: Principal Investigator: Gary F Lewis, MD, UHN

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 18, 2022
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Intestinal lipoprotein; Duodenal biopsy; Gut Peptide; Chylomicrons
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Physiological Effects of Drugs; Gastrointestinal Agents; Protective Agents; Radiation-Protective Agents; Teduglutide
• Other Study ID Numbers: 16-6368.2

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
• product manufactured in and exported from the U.S.: No