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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1194-9675 | Registry Identifier | Universal Trial Number |
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| Name | Class |
|---|---|
| University of Geneva, Switzerland | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide 3.0 mg | Experimental | 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). |
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| Placebo | Placebo Comparator | 35 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Placebo by pen injector. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change of body weight | Weight measurement (kg) | 16 weeks |
| changes in waist circumference | waist circumference measurement (cm) | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zoltan Pataky, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Geneva | Geneva | 1206 | Switzerland |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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Randomized, single-centre, double-blind, placebo controlled, parallel group, clinical trial.
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| changes in fasting blood sugar | fasting glycaemia measurement (mmol/l) | 16 weeks |
| changes in glucagon | glucagon measurement (pmol/l) | 16 weeks |
| changes in ghrelin | ghrelin measurement (mg/dl) | 16 weeks |
| changes in leptin | leptin measurement (ng/ml) | 16 weeks |
| changes in obestatin | obestatin measurement (ng/ml) | 16 weeks |
| changes in reelin | reelin measurement (ng/microL) | 16 weeks |
| changes in endocannabinoids | measurement of anandamide (AEA), 2-arachidonoylglycerol (2-AG), N-palmitoylethanolamide (PEA), N-oleoylethanolamide (OEA); ng/ml for all | 16 weeks |
| changes in insulin | fasting insulinaemia measurement (mUI/l) | 16 weeks |
| change in food addiction score | Assessment by YFAS V.2 questionnaire, 25 questions, total score is reported | 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"). | 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. | 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. | 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 | baseline comparison |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |