Metformin Treatment in Polycystic Ovary Syndrome (PCOS)
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|ClinicalTrials.gov Identifier: NCT02198417|
Recruitment Status : Active, not recruiting
First Posted : July 23, 2014
Last Update Posted : March 22, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Drug: Metformin ER||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Metformin on Mitochondrial Function in Polycystic Ovary Syndrome|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 2020|
Metformin ER 1500 mg per day treatment for 12 weeks
Drug: Metformin ER
Treatment with metformin ER for 12 weeks
Other Name: Glucophage
- Muscle Metabolism/Mitochondrial Function [ Time Frame: 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)
- Genetic risk variants affecting mitochondrial function/metabolism [ Time Frame: 3 months ]Blood will be analyzed for differences in genes between patients and its relationship to mitochondrial function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198417
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Corrine Welt, M.D.||Massachusetts General Hospital|