fMRI of Stress in Obesity
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: October 29, 2012
Last updated: September 25, 2014
Last verified: September 2013
To examine the influence of obesity on brain activation during food cue, stress, and neutral relaxing conditions
||Observational Model: Case Control
Time Perspective: Prospective
||Functional Magnetic Resonance Imaging of Stress in Obesity
Primary Outcome Measures:
- No outcome measures for this study, this is an imaging study only [ Time Frame: Upon study completion ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||May 2013 (Final data collection date for primary outcome measure)
Subjects deemed to be medically healthy
Subjects deemed to be medically obese
Subjects will participate in an fMRI session to examine changes in frontal and limbic brain regions with food cues, stress and neutral/relaxing imagery
|Ages Eligible for Study:
||18 Years to 50 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
30 obese subjects and 30 matched healthy controls will be recruited for this study.
- Between ages 18-50 years old.
- Able to read and write.
- negative urine toxicology screens during intake appointments indicating no history of current or past dependence on alcohol or illicit drug use.
- WOMEN: have a regular menstrual cycle.
- 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)
- 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;
- Regular use of any psychoactive drugs including anxiolytics and antidepressants.
- Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded.
- Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded including subjects who work as welders.
- Women on oral contraceptives, peri- and post-menopausal women, and pregnant or lactating women (as alterations in stress response are associated with these states).
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719484
|Yale University School of Medicine
|New Haven, Connecticut, United States, 06519 |
||Marc N Potenza, MD, PhD
No publications provided
ClinicalTrials.gov processed this record on March 03, 2015
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 29, 2012
||September 25, 2014
||United States: Institutional Review Board