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

University Health Network, Toronto

Status and phase

Completed

Phase 3

Phase 2

Conditions

Hyperlipidemias

Treatments

Drug: Teduglutide

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03442972

16-6368.2

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No 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