Metformin Treatment in Polycystic Ovary Syndrome (PCOS)
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| ClinicalTrials.gov Identifier: NCT02198417 |
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Recruitment Status :
Active, not recruiting
First Posted : July 23, 2014
Last Update Posted : August 16, 2018
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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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Metformin
Metformin ER 1500 mg per day treatment for 12 weeks
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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.
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| Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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)
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
| Principal Investigator: | Corrine Welt, M.D. | Massachusetts General Hospital |
Publications:
| Responsible Party: | Corrine Welt, Professor of Medicine, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT02198417 History of Changes |
| Other Study ID Numbers: |
2014P000911 R01HD065029 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 23, 2014 Key Record Dates |
| Last Update Posted: | August 16, 2018 |
| Last Verified: | August 2018 |
Keywords provided by Corrine Welt, Massachusetts General Hospital:
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Polycystic Ovary Syndrome PCOS Acne Infertility |
Irregular menses Irregular period Mitochondria Metabolism |
Additional relevant MeSH terms:
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Syndrome Polycystic Ovary Syndrome Disease Pathologic Processes Ovarian Cysts Cysts Neoplasms Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Metformin Hypoglycemic Agents Physiological Effects of Drugs |