Clinical trial NCT03347890: Reward Mechanisms in Obesity
Official title: Central Nervous System Effects of Liraglutide® 3.0 mg on Reward Mechanisms in Obese Patients Without Diabetes, in Relation to Food Addiction. A Randomized, Single-centre, Double-blind, Placebo Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: GLP-1
fMRI
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University of Geneva, Switzerland
First posted: 2017-11-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-centre, double-blind, placebo controlled, parallel group, clinical trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of Bold Oxygenation Level Dependent (BOLD) signal (%) in brain regions involved in the reward system
timeFrame: 16 weeks
Secondary outcomes:
measure: change of body weight
timeFrame: 16 weeks
measure: changes in waist circumference
timeFrame: 16 weeks
measure: changes in fasting blood sugar
timeFrame: 16 weeks
measure: changes in glucagon
timeFrame: 16 weeks
measure: changes in ghrelin
timeFrame: 16 weeks
measure: changes in leptin
timeFrame: 16 weeks
measure: changes in obestatin
timeFrame: 16 weeks
measure: changes in reelin
timeFrame: 16 weeks
measure: changes in endocannabinoids
timeFrame: 16 weeks
measure: changes in insulin
timeFrame: 16 weeks
measure: change in food addiction score
timeFrame: 16 weeks
measure: change in liking
timeFrame: 16 weeks
measure: change in wanting
timeFrame: 16 weeks
measure: change in emotional regulation abilities
timeFrame: 16 weeks
measure: BOLD in brain regions involved in the reward system
timeFrame: baseline comparison
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Zoltan Pataky, MD
role: PRINCIPAL_INVESTIGATOR
References: