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

Phase 2

Completed

• Conditions: Hyperlipidemias
• Interventions: Drug: Teduglutide; Drug: Placebo

• Registration Number: NCT03442972
• Lead Sponsor: University Health Network, Toronto

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.

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 Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-22
• Study Start: 2019-01-17
• Status Verified: 2020-11
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-01
• Last Update Submitted: 2022-05-18
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teduglutide	Teduglutide	Teduglutide, up to 0.05mg/kg, subcutaneous, single dose
Placebo	Placebo	Placebo, subcutaneous, single dose

Primary Outcome Measures

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

Trial Locations

Locations (2)

Kensington Screening Clinic; 🇨🇦 Toronto, Ontario, Canada

Toronto General Hopital; 🇨🇦 Toronto, Ontario, Canada