Reward Mechanisms in Obesity

Sponsor
Zoltan Pataky
Study ID
NCT03347890
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 5, 2018
Status verified
Apr 2021
Primary completion
Mar 18, 2020
Completion
Mar 30, 2020

Study Design

Enrollment
70 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide 3.0 mg
    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 Comparator: 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 Measure

Change of Bold Oxygenation Level Dependent (BOLD) signal (%) in brain regions involved in the reward system [ Time Frame: 16 weeks ]

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