Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Influence of Insulin Resistance on Cognitive, Emotional and Opioid System Functioning in Women With Polycystic Ovary Syndrome|
- 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 ]
- Hormonal studies [ Time Frame: prior to and following 4-months metformin treatment ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
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.
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 Name: Glucophage
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.
|United States, Michigan|
|University of Michigan, Michigan Clinical Research Unit|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Yolanda R Smith, MD, MS||University of Michigan, Obstetrics and Gynecology|