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Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome - NCT00670800-48109(Clinical Trial 218637)



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City:  Ann Arbor
State:  
MI
Zip Code: 48109
Conditions: Polycystic Ovary Syndrome
Purpose: The purpose of this study is to evaluate the effects of insulin resistance on brain function in women with Polycystic Ovary Syndrome (PCOS). PCOS affected women will be evaluated prior to and following 4-month treatment with metformin. Additionally, brain function in women with PCOS will be compared to the brain activity in normal control subjects with regular menstrual cycles.
Study summary: The pathogenesis of Polycystic Ovary Syndrome (PCOS), a reproductive and metabolic disorder, is associated with insulin resistance. The effects of insulin resistance on cognition, mood, opioid system and reproductive function in PCOS affected women are investigated in the current study. The identification of reversible changes in brain function and reproductive measures in insulin resistant PCOS patients would likely significantly influence treatment protocols for these young women. AIM I. Determine whether identifiable differences can be observed in cognitive and emotional processing between women with insulin resistant PCOS compared to normal controls using validated fMRI tasks. AIM II. Determine whether treatment with oral hypoglycemic agent will alter cognitive processing as measured with validated fMRI cognitive and emotional tasks. AIM III. Evaluate the differences in opioid tone in women with insulin resistant PCOS compared to normal controls. AIM IV. Evaluate whether an oral hypoglycemic agent is capable of altering opioid tone in women with insulin resistant PCOS.
Criteria: Inclusion Criteria: - Subjects with insulin resistant PCOS, irregular menstrual cycles and hyperandrogenism. - Normal controls with regular menstrual cycles - Normal hormonal levels, without hirsutism and acne are BMI matched and screened for insulin resistance prior to inclusion. Exclusion Criteria: - Left handedness - Acute medical illness - Uncorrected thyroid disease - Diabetes renal - Cardiac or pulmonary insufficiency - Active liver disease - Neurological disease - Current psychiatric illness - Claustrophobia - Contraindications to MRI - Smoking - Use of hormones - Centrally acting or insulin sensitizing mediations - Allergy to any opioid medication - Substance abuse - Pregnancy - BMI >35.
Study is available at: University of Michigan, Michigan Clinical Research Unit
Ann Arbor, MI 48109
United States

Primary Contact:
Anne Tkaczyk, MS
Email: tkaczyk@umich.edu
Phone: 734-647-7266

Secondary Contact:
Anne Tkaczyk, M.S.
Email: tkaczyk@umich.edu
Phone: 734-647-7266
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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