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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
15
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.
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.
MMC activity compared between placebo and treatment with liraglutide
On the 4th day of a treatment arm, the liraglutide or placebo injection is combined with a motility study. A solid-state, high-resolution manometry catheter is placed to measure intragastric pressure (IGP; mmHg). Antroduodenal contractility will be measured during the fasted state.
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.
Gastrointestinal hormone release compared between placebo and treatment with liraglutide
On the 4th and 5th day of a treatment arm, blood samples are taken to measure motilin and ghrelin release in the plasma at regular time points.
Time frame: Reference sample is taken at 7:50 in the morning. Other blood samples are taken from every 30 min after the injection (8am). The 4th day, this stops at 13:00 and the 5th day at 15:00. No samples are taken during the buffet at day 5 (13:30 until 14:15).
Hunger sensations compared between placebo and treatment with liraglutide
On the 4th and 5th day of a treatment arm, hunger sensations (hunger, prospective hunger and satiety) are scored on a visual analog scale of 100 mm.
Time frame: Hunger is scored every 5 min for 6 hours at day 4 of the treatment, starting at 7:00 and ending at 13:00. At day 5, hunger is scored every 5 min for 7 hours and 20 min starting at 7:40 and ending at 15:00, except during 13:30 and 14:15 (buffet).
Ad libitum food intake compared between placebo and treatment with liraglutide
On the 5th day of a treatment arm, the liraglutide or placebo injection is combined with an ad libitum buffet test. In the morning, the subjects eat a standardized breakfast. Five hours later, the subjects have the opportunity to eat ad libitum from a free choice buffet. All types of food are presented, and all are weighted before and after the experiment to measure the consumed amount of calories.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: The buffet will be given 5 hours after the consumption of a standardized breakfast which was given half an hour after the subcutaneous injection. Subjects have 45 min to finish the buffet.
Glucose whole blood levels compared between placebo and treatment with liraglutide
On the 4th and 5th day of a treatment arm, glucose whole blood levels are measured directly with a glucometer in parallel with the collection of blood samples.
Time frame: Reference sample is taken at 7:50 in the morning. Other glucose samples are taken from every 30 min after the injection (8am). The 4th day, this stops at 13:00 and the 5th day at 15:00. No samples are taken during the buffet at day 5 (13:30 until 14:15).