This trial is active, not recruiting.

Condition obesity
Sponsor Yale University
Start date May 2008
End date May 2015
Trial size 60 participants
Trial identifier NCT01719484, 0805003899


To examine the influence of obesity on brain activation during food cue, stress, and neutral relaxing conditions

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Subjects deemed to be medically healthy
Subjects deemed to be medically obese

Primary Outcomes

No outcome measures for this study, this is an imaging study only
time frame: Upon study completion

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: 1. Between ages 18-50 years old. 2. Able to read and write. 3. negative urine toxicology screens during intake appointments indicating no history of current or past dependence on alcohol or illicit drug use. 4. WOMEN: have a regular menstrual cycle. 5. BMI: 30 < BMI < 35 for obese subjects (upper limit of 35 selected given our experience with heavier individuals fitting comfortably in the fMRI scanner) and 18.5 < BMI <25 for normal weight subjects (Institute, 2006) Exclusion Criteria: 1. any major neurological illness or injury and any current or prior clinically significant mental health (including PTSD) or substance use disorder (with exception of nicotine dependence) as determined by SCID interview; 2. Regular use of any psychoactive drugs including anxiolytics and antidepressants. 3. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded. 4. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded including subjects who work as welders. 5. Women on oral contraceptives, peri- and post-menopausal women, and pregnant or lactating women (as alterations in stress response are associated with these states).

Additional Information

Official title Functional Magnetic Resonance Imaging of Stress in Obesity
Principal investigator Marc N Potenza, MD, PhD
Description Subjects will participate in an fMRI session to examine changes in frontal and limbic brain regions with food cues, stress and neutral/relaxing imagery
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Yale University.