The study aims to investigate the effects of 3.0 mg of liraglutide on reward brain circuits in human obesity and to better understand its effects on weight loss (in patients without diabetes). According to the study protocol, 70 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg) or Placebo by pen injector. All participants will first undergo a functional Magnetic Resonance Imaging (fMRI) session while being presented with gustatory stimuli. Second, participants will complete behavioural tasks (i.e., liking versus wanting, in the scanner) and questionnaires aiming at teasing apart reward mechanisms and emotional skills (e.g., emotional regulation ability) associated with food intake. Third, metabolic parameters and hormones involved in appetite regulation will be assessed and studied in relation to fMRI. These measurements will be repeated after 16 weeks in obese individuals. The control group of normal body weight individuals will be evaluated once at Baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Patients will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg) or Placebo by pen injector.
University Hospitals of Geneva
Geneva, Switzerland
Change of Bold Oxygenation Level Dependent (BOLD) signal (%) in brain regions involved in the reward system
Bold changes in striatum, amygdala, insula, orbitofrontal complex as detected by fMRI in from baseline to 16-week follow-up
Time frame: 16 weeks
change of body weight
Weight measurement (kg)
Time frame: 16 weeks
changes in waist circumference
waist circumference measurement (cm)
Time frame: 16 weeks
changes in fasting blood sugar
fasting glycaemia measurement (mmol/l)
Time frame: 16 weeks
changes in glucagon
glucagon measurement (pmol/l)
Time frame: 16 weeks
changes in ghrelin
ghrelin measurement (mg/dl)
Time frame: 16 weeks
changes in leptin
leptin measurement (ng/ml)
Time frame: 16 weeks
changes in obestatin
obestatin measurement (ng/ml)
Time frame: 16 weeks
changes in reelin
reelin measurement (ng/microL)
Time frame: 16 weeks
changes in endocannabinoids
measurement of anandamide (AEA), 2-arachidonoylglycerol (2-AG), N-palmitoylethanolamide (PEA), N-oleoylethanolamide (OEA); ng/ml for all
Time frame: 16 weeks
changes in insulin
fasting insulinaemia measurement (mUI/l)
Time frame: 16 weeks
change in food addiction score
Assessment by YFAS V.2 questionnaire, 25 questions, total score is reported
Time frame: 16 weeks
change in liking
Assessment by Pavlovian-Instrumental Transfer (PIT) test during fMRI scanning. Participants will taste the milkshake and tasteless solutions and asked to rate them based on how much they liked tasting the stimulus on a visual analogue scale (ranging from 1 "not at all" to 100 "extremely").
Time frame: 16 weeks
change in wanting
Assessment by Pavlovian-Instrumental Transfer (PIT) test during fMRI scanning. We will measure the mobilized effort (using a handgrip) the participants mobilized to be delivered with the milkshake.
Time frame: 16 weeks
change in emotional regulation abilities
Assessed by an emotional regulation task. Subjects will be presented with neutral, positive, negative, and mixed emotional feelings film clips and asked to either attend naturally or decrease their emotional reactions. The clips will be rated on amusement and repulsion scales on a 6-point scale. Based on these ratings, we will calculate a mixed feelings coefficient.
Time frame: 16 weeks
BOLD in brain regions involved in the reward system
BOLD (%) in striatum, amygdala, insula, orbitofrontal complex as detected by fMRI in the obese groups at baseline in comparison to normal body weight controls
Time frame: baseline comparison
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