NCT04008290

The Effect of Liraglutide on the GIT

The Effect of Liraglutide on MMC Activity, Gastrointestinal Hormones, Hunger Ratings and ad Libitum Food Intake in Healthy Volunteers

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Liraglutide is a glucose-like peptide 1 agonist, currently used as an effective weight-loss treatment. Its mechanism of action has not yet been elucidated. We want to investigate whether liraglutide affects MMC activity, gastrointestinal hormone release, glucose whole blood levels, hunger ratings and ad libitum food intake in healthy volunteers.

Detailed description

Liraglutide is a glucose-like peptide 1 (GLP-1) agonist, currently used as an effective weight-loss treatment. Its mechanism of action has not yet been elucidated. GLP-1 infusion in humans suppresses hunger-inducing MMC contractility. Therefore, we will recruit 15 healthy subjects which will participate to this double-blind, placebo-controlled crossover trial. The subjects will receive both treatment arms: 5 consecutive days of placebo injection or 0.6 mg liraglutide injection. On the 4th day, the injection will be combined with a motility study (fasted state), and on the 5th day with an ad libitum buffet. The primary outcome of this study is to investigate whether liraglutide decreases MMC activity, measured by a solid-state, high-resolution manometry catheter (only on 4th day of the treatment arm). The amount and preference for certain types of food is tested during an ad libitum free choice buffet (only on 5th day of treatment arm). The effect on gastrointestinal hormone release will be measured by taking blood samples at regular time points (both 4th and 5th day of treatment arm). In parallel with the blood sample collection, glucose whole blood levels are measured. Hunger-related sensations are scored on a visual analog scale of 100 mm at regular time points (both 4th and 5th day of treatment arm).

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	0.6 mg Liraglutide	For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of 0.6 mg liraglutide. The injection will be placed by a trained nurse at 8 o'clock every morning. A wash out period of at least one week will be respected between the two treatment weeks.
DRUG	Placebo	For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of placebo (0.9% saline solution). The injection will be placed by a trained nurse at 8 o'clock every morning. A wash out period of at least one week will be respected between the two treatment weeks.

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2019-07-05
• Last updated: 2019-07-05