FHA: Characterization of Metabolic Status, Brain Circuitry, and Stress-Reactivity
NCT ID: NCT00453219
Last Updated: 2013-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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1
Women ages 18-35 years with regular ovulatory menstrual cycles
Screening evaluation
A detailed history will be taken and a physical examination performed along with a blood sample to verify ovulatory status in women with regular cycles and determine cause of anovulation in women with irregular or absent menstrual cycles.
Meal Response
The investigators are interested in how nutrition and metabolism can influence reproduction and they will look at how the body senses hunger and how it responses to food. Blood samples will be collected and questionnaires given to assess responses and feeling about hunger and food.
Blood Collection
A blood sample will be collected and used to check for genetic markers of stress vulnerability.
Functional MRI
research participants will have an functional MRI scan of their brain while reviewing word lists associated with body image and emotions. This procedure will last about 1 hour.
Endocrine Assessment
research participants will have a 30 hour inpatient hospital admission with every 15 minute blood sampling for 24 hours. Hormone measures of stress, reproduction, and appetite will be obtained.
2
Women ages 18-35 years with irregular or absent menstrual periods due to functional hypothalamic amenorrhea (FHA) also called stress-induced anovulation
Screening evaluation
A detailed history will be taken and a physical examination performed along with a blood sample to verify ovulatory status in women with regular cycles and determine cause of anovulation in women with irregular or absent menstrual cycles.
Meal Response
The investigators are interested in how nutrition and metabolism can influence reproduction and they will look at how the body senses hunger and how it responses to food. Blood samples will be collected and questionnaires given to assess responses and feeling about hunger and food.
Blood Collection
A blood sample will be collected and used to check for genetic markers of stress vulnerability.
Functional MRI
research participants will have an functional MRI scan of their brain while reviewing word lists associated with body image and emotions. This procedure will last about 1 hour.
Endocrine Assessment
research participants will have a 30 hour inpatient hospital admission with every 15 minute blood sampling for 24 hours. Hormone measures of stress, reproduction, and appetite will be obtained.
3
Women ages 18-35 years with irregular or absent menstrual periods due to polycystic ovary syndrome(PCOS).
Screening evaluation
A detailed history will be taken and a physical examination performed along with a blood sample to verify ovulatory status in women with regular cycles and determine cause of anovulation in women with irregular or absent menstrual cycles.
Meal Response
The investigators are interested in how nutrition and metabolism can influence reproduction and they will look at how the body senses hunger and how it responses to food. Blood samples will be collected and questionnaires given to assess responses and feeling about hunger and food.
Blood Collection
A blood sample will be collected and used to check for genetic markers of stress vulnerability.
Functional MRI
research participants will have an functional MRI scan of their brain while reviewing word lists associated with body image and emotions. This procedure will last about 1 hour.
Endocrine Assessment
research participants will have a 30 hour inpatient hospital admission with every 15 minute blood sampling for 24 hours. Hormone measures of stress, reproduction, and appetite will be obtained.
Interventions
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Screening evaluation
A detailed history will be taken and a physical examination performed along with a blood sample to verify ovulatory status in women with regular cycles and determine cause of anovulation in women with irregular or absent menstrual cycles.
Meal Response
The investigators are interested in how nutrition and metabolism can influence reproduction and they will look at how the body senses hunger and how it responses to food. Blood samples will be collected and questionnaires given to assess responses and feeling about hunger and food.
Blood Collection
A blood sample will be collected and used to check for genetic markers of stress vulnerability.
Functional MRI
research participants will have an functional MRI scan of their brain while reviewing word lists associated with body image and emotions. This procedure will last about 1 hour.
Endocrine Assessment
research participants will have a 30 hour inpatient hospital admission with every 15 minute blood sampling for 24 hours. Hormone measures of stress, reproduction, and appetite will be obtained.
Eligibility Criteria
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Inclusion Criteria
18 Years
35 Years
FEMALE
Yes
Sponsors
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Emory University
OTHER
Responsible Party
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Principal Investigators
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Sarah L Berga, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University
Atlanta, Georgia, United States
Countries
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References
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Berga SL, Marcus MD, Loucks TL, Hlastala S, Ringham R, Krohn MA. Recovery of ovarian activity in women with functional hypothalamic amenorrhea who were treated with cognitive behavior therapy. Fertil Steril. 2003 Oct;80(4):976-81. doi: 10.1016/s0015-0282(03)01124-5.
Marcus MD, Loucks TL, Berga SL. Psychological correlates of functional hypothalamic amenorrhea. Fertil Steril. 2001 Aug;76(2):310-6. doi: 10.1016/s0015-0282(01)01921-5.
Berga SL, Loucks TL. Use of cognitive behavior therapy for functional hypothalamic amenorrhea. Ann N Y Acad Sci. 2006 Dec;1092:114-29. doi: 10.1196/annals.1365.010.
Other Identifiers
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IRB00024918
Identifier Type: -
Identifier Source: org_study_id