Polycystic Ovary Syndrome
Conditions
Brief summary
The investigator's global hypothesis is that women with Polycystic Ovary Syndrome (PCOS) can be separated into subtypes based on their response to metformin. The investigators propose here to use both targeted and non-targeted metabolomic approach to identify pathways associated with metformin's effect on insulin sensitivity and endothelial function. This pilot project will be the foundation for developing tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug targets.
Detailed description
The investigators propose to use both targeted and non-targeted metabolomic approaches to identify pathways associated with metformin's effect on insulin sensitivity, weight, androgens and endothelial function. This project will be the foundation for developing tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug targets. This pilot project is intended to inform the development of hypothesis and specific aims for a future grant application to National Institutes of Health (NIH).
Interventions
DRUGMetformin
Approximately 37 patients will start metformin therapy 3 months after their visit 2. All other patients will receive metformin therapy at their visit 2.
Sponsors
Abbott Medical Devices
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index (BMI) greater than or equal to 25 * Polycystic Ovary Syndrome criteria of both oligomenorrhea (\<9 menses per year) and androgen excess \[clinical hirsutism (Ferriman-Gallway score \>8 or severe acne) or elevated testosterone\]. * Taking no medications for the treatment of insulin resistance.
Exclusion criteria
* Diagnosis of Cushing's syndrome * Untreated hypo/hyperthyroidism * Elevated prolactin * Congenital adrenal hyperplasia * Renal insufficiency (creatinine \> 1.5) * Diabetes * Medications that can significantly affect endothelial function * Pregnancy * Breast Feeding * Taking oral contraceptives * Currently smoking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insulin Sensitivity (SI) after 3 Months of Metformin Therapy | Baseline, 3 months | Insulin sensitivity will be calculated using an oral glucose minimal model. Insulin under the curve will be calculated geometrically with the trapezoidal rule. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peripheral Flow-Mediated Vasodilatation after 3 Months of Metformin Therapy | baseline, 3 months | The ratio of Peripheral Digital Arterial Tonometry (PAT) signal after cuff release compared with baseline is calculated through a computer algorithm normalizing for baseline measurements and indexing to measurements in the contra-lateral arm. The calculated ratio reflects the reactive hyperemia index (RHI). |
Other
| Measure | Time frame |
|---|---|
| Change in Weight | baseline, 3 months |
| Change in Testosterone | baseline, 3 months |
Countries
United States
Outcome results
None listed