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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT03442972

Collaborator

Kensington Screening Clinic (Other)

Enrollment

Locations

Arms

34.5

Actual Duration (Months)

10.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemias	Drug: Teduglutide Drug: Placebo	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Masking Description:

Single-blinded study with participant blinded to treatment

Primary Purpose:

Basic Science

Official Title:

Investigating the Release of Stored Enteral Lipids in Response to a Single Subcutaneous Dose of Analogue Glucagon-like Peptide-2 in Humans

Actual Study Start Date :

Jan 17, 2019

Actual Primary Completion Date :

Jun 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto General Hopital	Toronto	Ontario	Canada	M5G 2C4
2	Kensington Screening Clinic	Toronto	Ontario	Canada	M5T 3A9

Sponsors and Collaborators

University Health Network, Toronto
Kensington Screening Clinic

Investigators

Principal Investigator: Gary F Lewis, MD, UHN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT03442972

Other Study ID Numbers:

16-6368.2

First Posted:

Feb 22, 2018

Last Update Posted:

May 25, 2022

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by University Health Network, Toronto

Intestinal lipoprotein

Duodenal biopsy

Gut Peptide

Chylomicrons

Additional relevant MeSH terms:

Hyperlipidemias

Teduglutide

Study Results

No Results Posted as of May 25, 2022