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Functional MRI of Stress in Obesity

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ClinicalTrials.gov Identifier: NCT01719484
Recruitment Status : Active, not recruiting
First Posted : November 1, 2012
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
To examine the influence of obesity on brain activation during food cue, stress, and neutral relaxing conditions

Condition or disease
Obesity

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

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Functional Magnetic Resonance Imaging of Stress in Obesity
Study Start Date : May 2008
Actual Primary Completion Date : May 2015
Estimated Study Completion Date : May 2019
Groups and Cohorts
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Group/Cohort
Healthy
Subjects deemed to be medically healthy
Obese
Subjects deemed to be medically obese


Outcome Measures
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Primary Outcome Measures :
  1. No outcome measures for this study, this is an imaging study only [ Time Frame: Upon study completion ]

Eligibility Criteria
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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
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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
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01719484     History of Changes
Other Study ID Numbers: 0805003899
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

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