Healthy Human Male Subjects Clinical Trial
Official title:
The Influence of Liraglutide on the Reward Properties of Food: an fMRI Study on Healthy Volunteers
Clinical experience has confirmed the anorexic effect of Glucagon-like-peptide 1 (GLP-1)
mimetics in comparison to DPP-4 inhibitors. A possible mechanism of this effect might be
associated with changes in food choices, as suggested by animal studies. It has been shown
that functional magnetic resonance imaging (fMRI) of the brain is a valuable tool in obesity
research and can be used to study the response of several brain regions to the visual
presentation of preferred in comparison to non preferred food items and to non food items
The aim of this study is to search for possible effects of liraglutide in comparison to
placebo on 1. food choices and 2. changes in brain function as evidenced by fMRI in healthy
volunteers.
Findings of this study will help not only to get deeper insight into the mechanism of the
anorexic effect of GLP-1 mimetics, but also into the regulation of food choices per se. In
the future, it is planned to extend the results of this study in normal weight volunteers to
obese diabetic subjects.
Design: The study is designed as a double blind, placebo controlled, randomized crossover
intervention study with two arms (liraglutide first followed by placebo vs. placebo first
followed by liraglutide) in 16 healthy male volunteers. fMRI results and food intake are
compared between groups baseline vs. end of treatment period and placebo vs. liraglutide.
Intervention: A standard dose of 0.6 mg Liraglutide (oder placebo) will be used, and will be
applied subcutaneously each morning for three subsequent days by the study personnel. Study
sessions will be performed on the fourth day after placebo/liraglutide interventions.
Study sessions: On study days participants arrive at the trial centre at 8.00 am after a 12h
fast. Participants are instructed to eat a light dinner around 8.00 pm the previous day and
to spend around 8h resting during the night before the study days. Upon arrival, blood
pressure and heart rate is measured and an iv line is started, from which a blood sample is
taken from the antecubital vein for blood glucose, insulin and plasma hormone concentrations
determination. The occurrence of nausea, vomiting, dizziness or any other adverse events
(AE's) is reviewed together with the subject.
Instructions for the fMRI examination are reviewed together with the subject. The subject is
advised to leave all ferromagnetic items behind, and baseline hunger/satiety visual analogue
scales (VAS) are recorded. Then, the fMRI session with the food items paradigm (together
with repeated recordings of hunger/satiety VAS) takes place. Afterwards, another blood
sample and hunger/satiety VAS is taken and the subject is allowed to eat ad libitum from a
buffet breakfast. Food intake is recorded in detail, including meal choices and calorie
intake. After a final hunger/satiety VAS recording and another blood sample subjects are
dismissed from the trial centre.
Outcome variables: Main outcome variables are fMRI activity in the brain during the high
calorie/low calorie food items paradigm and food intake at the buffet liraglutide vs.
placebo at the end of treatment. Secondary outcome parameters are hunger/satiety VAS
ratings, total and active plasma ghrelin, peptide YY (PYY), glucose and insulin
concentrations.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science