Metformin Treatment in Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effects of Metformin on Mitochondrial Function in Polycystic Ovary Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02198417
• Other study ID #: 2014P000911
• Secondary ID: R01HD065029
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 2020

Study information

• Verified date: August 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Metformin ER
Treatment with metformin ER for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Utah

References & Publications (1)

Pau CT, Keefe C, Duran J, Welt CK. Metformin improves glucose effectiveness, not insulin sensitivity: predicting treatment response in women with polycystic ovary syndrome in an open-label, interventional study. J Clin Endocrinol Metab. 2014 May;99(5):1870-8. doi: 10.1210/jc.2013-4021. Epub 2014 Feb 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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