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

Hyperlipidemias Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442972
• Other study ID #: 16-6368.2
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 17, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias

Intervention

Drug:
• Teduglutide
Teduglutide
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	Kensington Screening Clinic	Toronto	Ontario
Canada	Toronto General Hopital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Kensington Screening Clinic

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Release of enteral lipids in response to teduglutide	To quantify the difference in amount of enteral lipids between GLP-2 and placebo treatment	6 hours