Reward Mechanisms in Obesity

Obesity Clinical Trial

— LIRAOB  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347890
• Other study ID #: 2017-01085
• Secondary ID: U1111-1194-9675
• Status: Completed
• Phase: Phase 4
• Start date: March 5, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: April 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 30, 2020
• Est. primary completion date: March 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo
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.

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Zoltan Pataky	University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	change of body weight	Weight measurement (kg)	16 weeks
Secondary	changes in waist circumference	waist circumference measurement (cm)	16 weeks
Secondary	changes in fasting blood sugar	fasting glycaemia measurement (mmol/l)	16 weeks
Secondary	changes in glucagon	glucagon measurement (pmol/l)	16 weeks
Secondary	changes in ghrelin	ghrelin measurement (mg/dl)	16 weeks
Secondary	changes in leptin	leptin measurement (ng/ml)	16 weeks
Secondary	changes in obestatin	obestatin measurement (ng/ml)	16 weeks
Secondary	changes in reelin	reelin measurement (ng/microL)	16 weeks
Secondary	changes in endocannabinoids	measurement of anandamide (AEA), 2-arachidonoylglycerol (2-AG), N-palmitoylethanolamide (PEA), N-oleoylethanolamide (OEA); ng/ml for all	16 weeks
Secondary	changes in insulin	fasting insulinaemia measurement (mUI/l)	16 weeks
Secondary	change in food addiction score	Assessment by YFAS V.2 questionnaire, 25 questions, total score is reported	16 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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