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

Primary Purpose

Hyperlipidemias

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Teduglutide

Placebo

About this trial

This is an interventional basic science trial for Hyperlipidemias focused on measuring Intestinal lipoprotein, Duodenal biopsy, Gut Peptide, Chylomicrons

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Toronto General Hopital
Kensington Screening Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Teduglutide

Placebo

Arm Description

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

Placebo, subcutaneous, single dose

Outcomes

Primary Outcome Measures

Release of enteral lipids in response to teduglutide

To quantify the difference in amount of enteral lipids between GLP-2 and placebo treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT03442972

First Posted

February 2, 2018

Last Updated

May 18, 2022

Sponsor

University Health Network, Toronto

Collaborators

Kensington Screening Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03442972

Brief Title

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

Acronym

GLP-2 Biopsy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

January 17, 2019 (Actual)

Primary Completion Date

June 1, 2021 (Actual)

Study Completion Date

December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

Collaborators

Kensington Screening Clinic

4. Oversight

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.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperlipidemias

Keywords

Intestinal lipoprotein, Duodenal biopsy, Gut Peptide, Chylomicrons

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Participant

Masking Description

Single-blinded study with participant blinded to treatment

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Teduglutide

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo, subcutaneous, single dose

Intervention Type

Drug

Intervention Name(s)

Teduglutide

Intervention Description

Teduglutide

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Release of enteral lipids in response to teduglutide

Description

To quantify the difference in amount of enteral lipids between GLP-2 and placebo treatment

Time Frame

6 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary F Lewis, MD

Organizational Affiliation

UHN

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto General Hopital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

Kensington Screening Clinic

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 3A9

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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