Metformin Treatment in Polycystic Ovary Syndrome (PCOS)

Not Applicable

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Metformin ER

• Registration Number: NCT02198417
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-23
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-16
• Primary Completion: 2020-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin ER	Metformin ER 1500 mg per day treatment for 12 weeks

Primary Outcome Measures

Name	Time	Method
Muscle Metabolism/Mitochondrial Function	3 months	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)

Secondary Outcome Measures

Name	Time	Method
Genetic risk variants affecting mitochondrial function/metabolism	3 months	Blood will be analyzed for differences in genes between patients and its relationship to mitochondrial function.