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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03442972

Acronym

GLP-2 Biopsy

Enrollment

Registered

2018-02-22

Start date

2019-01-17

Completion date

2021-12-01

Last updated

2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemias

Keywords

Intestinal lipoprotein, Duodenal biopsy, Gut Peptide, Chylomicrons

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.

Interventions

DRUGTeduglutide

Teduglutide

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Masking description

Single-blinded study with participant blinded to treatment

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026