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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03454711
Other study ID # 35RC17_8949_AddictO
Secondary ID 2017-A01269-44
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date April 26, 2018
Est. completion date September 8, 2021

Study information

Verified date May 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Identification of the cerebral fMRI phenotype of obese patients with FA in cognitive task context based on food choice making


Description:

Obesity is a worldwide epidemic associated with many complications. The treatment of obesity is a failure if it does not take into account eating disorders. Among them, food addictions seem to be frequent among obese patients. Clinical diagnosis and therapeutic approaches depend on presence of these FA. Moreover, eating disorders are associated with visible brain abnormalities in fMRI but the cerebral fMRI phenotype of FA is not known.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date September 8, 2021
Est. primary completion date September 8, 2021
Accepts healthy volunteers No
Gender Female
Age group 30 Years to 50 Years
Eligibility Inclusion Criteria: - female - right-handed - grade 1 and 2 obesity - aged between 20 and 50 - no other addictions including smoking - no contraindications to fMRI - affiliated to French Social Security - having given a written informed consent Exclusion Criteria: - abdominal circumference + upper limbs along the body > 200cm - addiction to alcohol or other psychoactive substances - daily smoker - sleep Apnea Syndrome paired - psychotic psychiatric disorders - history of bariatric surgery - medical care in the nutrition unit - inability to comprehend or complete questionnaires - pregnant or breastfeeding woman - persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
fMRI
Brain MRI
Indirect calorimetry
Resting energy expenditure
Bioimpedance
Measurement of body composition
Biological:
Lipid profile, glucose, HBA1c, metabolomic analysis
Blood sample
Behavioral:
YFAS questionnaire, Binge Eating Scale, Hospital Anxiety and Depression (HAD) scale, hedonic evaluation test (liking)
Questionnaires to characterize eating habits and depression

Locations

Country Name City State
France CHU de Rennes Rennes

Sponsors (2)

Lead Sponsor Collaborator
Rennes University Hospital Institut NuMeCan, INRAE 1341

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Significant change in brain activity of the prefrontal cortex (area involved in the inhibitory control of food intake) measured by modification of BOLD (Blood-Oxygen-Level-Dependent) signal in fMRI during a cognitive task based on food choice making Month 2
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