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

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02086526

UL1TR000135 (U.S. NIH Grant/Contract)

13-000692

Details and patient eligibility

About

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.

Full 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).

Enrollment: 68 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Metformin

Experimental group

Description:

Metformin 500 mg. extended release (taken orally) one tablet with evening meal for one week, one tablet with morning and evening meal for one week, and one tablet at all three meals for the next three months.

Treatment:

Drug: Metformin

Delayed Start Metformin

Other group

Description:

After baseline study visit, this arm will return after three months without metformin for a repeat of the baseline study visit prior to initiating metformin 500 mg. extended release (taken orally) one tablet with evening meal for one week, one tablet with morning and evening meal for one week, and one tablet at all three meals for the next three months.

Treatment:

Drug: Metformin