fMRI of Stress in Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01719484
First received: October 29, 2012
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Functional Magnetic Resonance Imaging of Stress in Obesity

Resource links provided by NLM:


Further study details as provided by Yale University:

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: 60
Study Start Date: May 2008
Estimated Study Completion Date: May 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy
Subjects deemed to be medically healthy
Obese
Subjects deemed to be medically obese

Detailed 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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

30 obese subjects and 30 matched healthy controls will be recruited for this study.

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719484

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Marc N Potenza, MD, PhD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01719484     History of Changes
Other Study ID Numbers: 0805003899
Study First Received: October 29, 2012
Last Updated: September 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014