Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)

Phase 1CompletedNCT02086526

Mayo Clinic68 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

MetforminDRUG

Approximately 37 patients will start metformin therapy 3 months after their visit 2. All other patients will receive metformin therapy at their visit 2.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in Insulin Sensitivity (SI) after 3 Months of Metformin Therapy

Insulin sensitivity will be calculated using an oral glucose minimal model. Insulin under the curve will be calculated geometrically with the trapezoidal rule.

Time frame: Baseline, 3 months

Secondary Outcomes

Change in Peripheral Flow-Mediated Vasodilatation after 3 Months of Metformin Therapy

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).

Time frame: baseline, 3 months

Data from ClinicalTrials.gov

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