Metformin Treatment in Polycystic Ovary Syndrome (PCOS)

Study Overview
=================
Brief Summary
-----------------
PCOS occurs when a woman does not release an egg regularly each month, causing her periods to be irregular. Women with PCOS can also have increased hair growth on the face and body, acne, head balding, infertility, pre-diabetes, and diabetes. PCOS is commonly treated with oral contraceptive pills (also known as the birth control pills). Sometimes, a medication called metformin is also used to treat PCOS, especially if a woman has evidence of insulin resistance or if fertility is desired. Unfortunately, metformin works in only some women with PCOS. The mechanism through which metformin works in PCOS is not clear and it difficult to predict who will benefit from metformin treatment and who will not. The investigators are doing this research study to look at how the medication metformin affects the cells in the body of patients with PCOS. Specifically, the investigators will look at how metformin affects the mitochondria. Mitochondria are the part of cells that produce fuel (energy) for other cells and play a role in metabolism. The investigators would like to see whether there is a relationship between mitochondrial activity and symptoms of polycystic ovary syndrome (PCOS) before and after treatment with metformin. They would also like to study whether genes affect the response to metformin in women with PCOS.

Detailed Description
-----------------
Women who are eligible to enroll in this study will be treated with the medication metformin for 12 weeks. Before and after treatment with metformin, the following will be assessed: Weight, blood pressure, waist circumference Lipids (cholesterol) Hormone levels (including testosterone and other androgens) IV glucose tolerance test (to assess for early evidence of insulin resistance) Effect of metformin on muscle mitochondria (this will involve one MRI scan and one muscle biopsy each before and after treatment with metformin) Ovulation will be closely monitored at least twice a month with pelvic ultrasounds and blood tests for estrogen and progesterone levels.

Official Title
-----------------
Effects of Metformin on Mitochondrial Function in Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Metformin ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Polycystic ovary syndrome No hormonal or antidiabetic medications for 1 month Good general health Exclusion Criteria: Smoker Acute infection or chronic disease Diabetes Pregnant or trying to get pregnant over next half year Bleeding disorders Any metal or foreign implants (e.g., aneurysm clips, ear implants, heart pacemakers or defibrillators)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br>Metformin ER 1500 mg per day treatment for 12 weeks | Drug: Metformin ER<br>* Treatment with metformin ER for 12 weeks<br>* Other names: Glucophage;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Metabolism/Mitochondrial Function | The change in mitochondrial activity before and after metformin treatment will be analyzed in relationship to the clinical response to 3 months of metformin treatment (i.e., clinical response to metformin = changes in glucose metabolism, hormone levels, and ovulation response) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic risk variants affecting mitochondrial function/metabolism | Blood will be analyzed for differences in genes between patients and its relationship to mitochondrial function. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic Ovary Syndrome, PCOS, Acne, Infertility, Irregular menses, Irregular period, Mitochondria, Metabolism