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Completed

NCT Number: NCT03347890

Reward Mechanisms in Obesity

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals of Geneva

Geneva, 1206, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change of Bold Oxygenation Level Dependent (BOLD) signal (%) in brain regions involved in the reward system

    Time frame: 16 weeks

    Bold changes in striatum, amygdala, insula, orbitofrontal complex as detected by fMRI in from baseline to 16-week follow-up

Secondary outcomes

  1. change of body weight

    Time frame: 16 weeks

    Weight measurement (kg)

  2. changes in waist circumference

    Time frame: 16 weeks

    waist circumference measurement (cm)

  3. changes in fasting blood sugar

    Time frame: 16 weeks

    fasting glycaemia measurement (mmol/l)

  4. changes in glucagon

    Time frame: 16 weeks

    glucagon measurement (pmol/l)

  5. changes in ghrelin

    Time frame: 16 weeks

    ghrelin measurement (mg/dl)

  6. changes in leptin

    Time frame: 16 weeks

    leptin measurement (ng/ml)

  7. changes in obestatin

    Time frame: 16 weeks

    obestatin measurement (ng/ml)

  8. changes in reelin

    Time frame: 16 weeks

    reelin measurement (ng/microL)

  9. changes in endocannabinoids

    Time frame: 16 weeks

    measurement of anandamide (AEA), 2-arachidonoylglycerol (2-AG), N-palmitoylethanolamide (PEA), N-oleoylethanolamide (OEA); ng/ml for all

  10. changes in insulin

    Time frame: 16 weeks

    fasting insulinaemia measurement (mUI/l)

  11. change in food addiction score

    Time frame: 16 weeks

    Assessment by YFAS V.2 questionnaire, 25 questions, total score is reported

  12. change in liking

    Time frame: 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").

  13. change in wanting

    Time frame: 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.

  14. change in emotional regulation abilities

    Time frame: 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.

  15. BOLD in brain regions involved in the reward system

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zoltan Pataky

Other

Collaborators

  • University of Geneva, Switzerland

Registry information

Official study 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.

Acronym: LIRAOB

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2017
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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