Plasma Lipoprotein Response to Glucagon-like Peptide-2

NCT03422666 | Completed Phase 2

• 1 other identifier: 16-6368.1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 evaluating how blood lipoproteins respond to teduglutide in healthy individuals.

Conditions

Hyperlipidemias

Keywords

Intestinal lipoprotein; Gut Peptide; Chylomicrons

Outcome Measures

Primary Outcomes (1)

• Lipoprotein response to teduglutide

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

  8 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: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

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

Study Sites (1)

Toronto General Hopital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Hyperlipidemias

Interventions

teduglutide

Condition Hierarchy (Ancestors)

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

Study Officials

• Gary 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: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: On visits 3 \& 4, participants will receive either teduglutide or placebo, in random order, 5 hours after a high-fat drink

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 6, 2018
• Study Start: September 21, 2018
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 14, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)