Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome
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.
Timeline
- Start
- 2008-01
- Primary completion
- 2009-08
- Completion
- 2009-08
Outcome
Mixed primary results
registry MEAN PCOS Affected Women Pre-Metformin (Baseline): 2.40 (Standard Deviation .11) ratio NCT00670800 ↗
registry MEAN PCOS Affected Women Post-Metformin (After 4 Months): 2.11 (Standard Deviation 0.21) ratio NCT00670800 ↗
registry analysis (superiority or other test); PCOS Affected Women Pre-Metformin (Baseline) vs PCOS Affected Women Post-Metformin (After 4 Months); p = 0.038; t-test, 2 sided NCT00670800 ↗
registry analysis (superiority or other test); PCOS Affected Women Pre-Metformin (Baseline) vs PCOS Affected Women Post-Metformin (After 4 Months); p = 0.133; t-test, 2 sided NCT00670800 ↗
Publications
- Results Berent-Spillson A, Love T, Pop-Busui R, Sowers M, Persad CC, Pennington KP, Eyvazaddeh AD, Padmanabhan V, Zubieta JK, Smith YR. Insulin resistance influences central opioid activity in polycystic ovary syndrome. Fertil Steril. 2011 Jun 30;95(8):2494-8. doi: 10.1016/j.fertnstert.2011.03.031. Epub 2011 Apr 12.
- Marsh CA, Berent-Spillson A, Love T, Persad CC, Pop-Busui R, Zubieta JK, Smith YR. Functional neuroimaging of emotional processing in women with polycystic ovary syndrome: a case-control pilot study. Fertil Steril. 2013 Jul;100(1):200-7.e1. doi: 10.1016/j.fertnstert.2013.02.054. Epub 2013 Apr 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 500 mg | Oral |