Metformin Treatment in Polycystic Ovary Syndrome (PCOS)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ovarian Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 3/23/2017 |
| Start Date: | July 2014 |
| End Date: | December 2020 |
Effects of Metformin on Mitochondrial Function in Polycystic Ovary Syndrome
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.
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.
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.
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.
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)
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-3038
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