- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01719484
Functional MRI of Stress in Obesity
July 11, 2022 updated by: Yale University
Functional Magnetic Resonance Imaging of Stress in Obesity
To examine the influence of obesity on brain activation during food cue, stress, and neutral relaxing conditions
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06519
- Yale University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
30 obese subjects and 30 matched healthy controls will be recruited for this study.
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy
Subjects deemed to be medically healthy
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Obese
Subjects deemed to be medically obese
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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No outcome measures for this study, this is an imaging study only
Time Frame: Upon study completion
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Upon study completion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marc N Potenza, MD, PhD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
October 29, 2012
First Submitted That Met QC Criteria
October 29, 2012
First Posted (Estimate)
November 1, 2012
Study Record Updates
Last Update Posted (Actual)
July 13, 2022
Last Update Submitted That Met QC Criteria
July 11, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0805003899
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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