In-vivo-quantification of both serotonin-and norepinephrin-transporter availability in obese persons without co-morbid depression using positron emission tomography (PET) and selective radio-labelled markers - comparison with healthy controls and 6 months after a multimodal treatment program

Not Applicable

• Conditions: eating behaviour, eating disorders; E66; Obesity

• Registration Number: DRKS00003537
• Lead Sponsor: niversitätsklinikum Leipzig AöRKlinik und Poliklinik für Nuklearmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-30
• Study Completion: 2015-03-02
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

•Age between 18 and 65
•BMI > 35 kg/m2 resp. <30 kg/m2
•no psychotropic-medication and/or drugs for at least 8 weeks prior PET
• written informed consent

Exclusion Criteria

• History of neurological or psychiatric diseases
• juvenile-onset diabetes (type 1) resp. insulin dependent diabetes type 2, malignant hypertension
• medical treatment or surgery for weight reduction less then 6 months ago
• Structural lesions (stroke, traumatic brain injury etc.)
• Cognitive deficits, major speech impairment, alcohol- or drug abuse (positive drug test)
• Major mental disorders, major communicative deficiencies which inhibit an informed consent
• neurosurgical interventions in the past
• Epilepsy, cerebral seizures in previous medical history (or in history of the family)
• Chronic diseases (e.g. asthma) indicating chronic medical treatment with central effect
• Pregnancy (exclusion via urine test before the experiment)
• Contraindications for MR imaging (e.g., implanted ferro-magnetic devices), claustrophobia

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
quantified central SERT /NET availability (binding-potential BP and distribution volume [ratios] DV[R]) in obese patients (BMI = 35 kg/m2) before compared to after participation in a multimodal treatment program in order to compare BP/DV[R] between the two groups (obese, obese after paricipation of treatment program and normal weighted).

Secondary Outcome Measures

Name	Time	Method
Correlation coefficients with other parameters like genotype, stress reaction, age, gender. Comparison of the obese subjects before and after 6 month of participation in the treatment program with the nomalweighted subjects.