Glucagon-like Peptide-2 Mediated Secretion of Stored Enteral Lipids

NCT03442972 | Completed Phase 2

• 1 other identifier: 16-6368.2
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

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) 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.

Conditions

Hyperlipidemias

Keywords

Intestinal lipoprotein; Duodenal biopsy; Gut Peptide; Chylomicrons

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Teduglutide

EXPERIMENTAL

Teduglutide, up to 0.05mg/kg, subcutaneous, single dose

Drug: Teduglutide

Placebo

PLACEBO COMPARATOR

Placebo, subcutaneous, single dose

Drug: Placebo

Interventions

Teduglutide DRUG

Teduglutide

Teduglutide

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Kensington Screening Clinic: collaborator

Study Sites (2)

Toronto General Hopital

Toronto, Ontario, M5G 2C4, Canada

Location

Kensington Screening Clinic

Toronto, Ontario, M5T 3A9, Canada

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

teduglutide

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Gary F Lewis, MD

  UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded study with participant blinded to treatment
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to receive either teduglutide or placebo as a single subcutaneous injection, 1 hour prior to duodenal biopsy

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 22, 2018
• Study Start: January 17, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 25, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)