Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reward Mechanisms in Obesity (LIRAOB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03347890
Recruitment Status : Completed
First Posted : November 20, 2017
Last Update Posted : April 30, 2021
Sponsor:
Collaborator:
University of Geneva, Switzerland
Information provided by (Responsible Party):
Zoltan Pataky, University Hospital, Geneva

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.


Condition or disease Intervention/treatment Phase
Obesity Drug: Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, single-centre, double-blind, placebo controlled, parallel group, clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : March 18, 2020
Actual Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
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).
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.

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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347890


Locations
Layout table for location information
Switzerland
University Hospitals of Geneva
Geneva, Switzerland, 1206
Sponsors and Collaborators
Zoltan Pataky
University of Geneva, Switzerland
Investigators
Layout table for investigator information
Principal Investigator: Zoltan Pataky, MD University Hospital, Geneva
Layout table for additonal information
Responsible Party: Zoltan Pataky, MD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT03347890    
Other Study ID Numbers: 2017-01085
U1111-1194-9675 ( Registry Identifier: Universal Trial Number )
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zoltan Pataky, University Hospital, Geneva:
GLP-1
fMRI
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists