Reward Mechanisms in Obesity
- Conditions
- Obesity
- Interventions
- Registration Number
- NCT03347890
- Lead Sponsor
- Zoltan Pataky
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- BMI ≥ 30 kg/m2 and < 40 kg/m2
- right-handed
- current non-smokers
- with stable body weight (<5% reported change during the previous 3 months)
- History of any psychiatric, neurological, cardiovascular, renal or liver disease, malignancies, type 1 and type 2 diabetes mellitus
- use of centrally acting medication, glucocorticoides, insulin, orlistat
- any substance abuse
- food allergies
- deficits of smell and taste
- history of pancreatitis
- family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma
- pregnancy
- contraindications for fMRI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liraglutide 3.0 mg Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo 35 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg). Placebo Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo 35 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Placebo by pen injector.
- Primary Outcome Measures
Name Time Method Change of Bold Oxygenation Level Dependent (BOLD) signal (%) in brain regions involved in the reward system 16 weeks Bold changes in striatum, amygdala, insula, orbitofrontal complex as detected by fMRI in from baseline to 16-week follow-up
- Secondary Outcome Measures
Name Time Method change of body weight 16 weeks Weight measurement (kg)
changes in endocannabinoids 16 weeks measurement of anandamide (AEA), 2-arachidonoylglycerol (2-AG), N-palmitoylethanolamide (PEA), N-oleoylethanolamide (OEA); ng/ml for all
changes in waist circumference 16 weeks waist circumference measurement (cm)
changes in glucagon 16 weeks glucagon measurement (pmol/l)
changes in ghrelin 16 weeks ghrelin measurement (mg/dl)
change in food addiction score 16 weeks Assessment by YFAS V.2 questionnaire, 25 questions, total score is reported
changes in fasting blood sugar 16 weeks fasting glycaemia measurement (mmol/l)
changes in leptin 16 weeks leptin measurement (ng/ml)
changes in obestatin 16 weeks obestatin measurement (ng/ml)
changes in reelin 16 weeks reelin measurement (ng/microL)
BOLD in brain regions involved in the reward system baseline comparison BOLD (%) in striatum, amygdala, insula, orbitofrontal complex as detected by fMRI in the obese groups at baseline in comparison to normal body weight controls
changes in insulin 16 weeks fasting insulinaemia measurement (mUI/l)
change in liking 16 weeks 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").
change in wanting 16 weeks 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.
change in emotional regulation abilities 16 weeks 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.
Trial Locations
- Locations (1)
University Hospitals of Geneva
🇨🇭Geneva, Switzerland