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fMRI of Stress in Obesity

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01719484
First Posted: November 1, 2012
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
  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

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 ]

Estimated Enrollment: 60
Study Start Date: May 2008
Estimated Study Completion Date: May 2018
Primary Completion Date: May 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01719484     History of Changes
Other Study ID Numbers: 0805003899
First Submitted: October 29, 2012
First Posted: November 1, 2012
Last Update Posted: April 25, 2017
Last Verified: December 2016

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