Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome | RxWiki

Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome

Overview[ - collapse ][ - ]

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.
Condition	Polycystic Ovary Syndrome
Intervention	Drug: Metformin
Phase	N/A
Sponsor	University of Michigan
Responsible Party	University of Michigan
ClinicalTrials.gov Identifier	NCT00670800
First Received	April 30, 2008
Last Updated	February 10, 2012
Last verified	February 2012

Tracking Information[ + expand ][ + ]

First Received Date	April 30, 2008
Last Updated Date	February 10, 2012
Start Date	January 2008
Estimated Primary Completion Date	December 2015
Current Primary Outcome Measures	PCOS affected women will be evaluated prior to and following 4-month metformin treatment utilizing the following measures: OGTT, neuropsychological testing battery, fMRI and PET scanning results. [Time Frame: Once] [Designated as safety issue: No]
Current Secondary Outcome Measures	Hormonal studies [Time Frame: prior to and following 4-months metformin treatment] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome
Official Title	Influence of Insulin Resistance on Cognitive, Emotional and Opioid System Functioning in Women With Polycystic Ovary Syndrome
Brief Summary	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.
Detailed Description	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.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Polycystic Ovary Syndrome
Intervention	Drug: Metformin Following the baseline studies, PCOS affected women will be initiated on metformin at a dose of 500 mg orally after breakfast and the dose will be increased the following week to 500 mg BID adding a dose after lunch. On the third week, a 500 mg tablet will be added after supper for a final dose of 500 mg orally TID. All subjects will be monitored for possible side effects such as nausea, vomiting, diarrhea, anorexia, and abdominal discomfort. These side effects tend to be mild, dose-related and improve with continued use of metformin. Hypoglycemia is rare and tends to occur in the setting of alcohol abuse or prolonged starvation. Malabsorption of vitamin B12 and folate occurs with long-term treatment, although it usually does not lead to anemia. Other Names: Glucophage
Study Arm (s)	No Intervention: 1: Control Control subjects will have 5 visits (screening, OGTT, neuropsych, fMRI and PET) as they will receive no treatment and will not have repeat studies. The baseline values obtained from the control subjects will be compared to the baseline values acquired from the PCOS affected subjects. Experimental: 2: PCOS Subjects with PCOS will be scheduled for 9 visits total: following the screening visit they will go through OGTT, neuropsychological testing, fMRI and PET scan before and after 4 months of metformin use.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	14
Estimated Completion Date	December 2015
Estimated Primary Completion Date	June 2009
Eligibility 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.
Gender	Female
Ages	21 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00670800
Other Study ID Numbers	2276
Has Data Monitoring Committee	No
Information Provided By	University of Michigan
Study Sponsor	University of Michigan
Collaborators	Not Provided
Investigators	Principal Investigator: Yolanda R Smith, MD, MS University of Michigan, Obstetrics and Gynecology
Verification Date	February 2012

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