The Effect of Liraglutide on the GIT

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT04008290
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • 0.6 mg Liraglutide — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 1, 2020
Status verified
Jul 2019
Primary completion
Apr 1, 2021
Completion
Apr 1, 2021

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: 0.6 mg Liraglutide
    For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of 100 µl containing 0.6 mg liraglutide.
  • Placebo Comparator: Placebo
    For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of 100 µl saline (0.9%) solution.

Primary Outcome Measure

MMC activity compared between placebo and treatment with liraglutide [ Time Frame: The catheter will be placed 1 hour before the subcutaneous administration. Antroduodenal contractility will be measured for 5 hours after liraglutide or placebo injection. ]

Central Contacts

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