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

What Was Tested

This registered phase 2, phase 3 trial tested Teduglutide (GLP-2 analog).

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.

It had two arms (groups): Teduglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Patients undergoing the procedure will be recruited.

Who Took Part

21 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: patients with active inflammatory bowel disease; patients with pre-existing celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption; patients with active bowel malignancy.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Because people in this Teduglutide (GLP-2 analog) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Teduglutide (GLP-2 analog) group and the comparison group ran side by side rather than switching.

In this single-blind Teduglutide (GLP-2 analog) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2019-01-17 with completion listed for 2021-06-01.

It ran at 2 sites in Canada (2).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Release of enteral lipids in response to teduglutide (time frame: 6 hours).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Teduglutide (GLP-2 analog) in 21 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teduglutide (GLP-2 analog) compound page, all human trials.