Effects of Metformin on Mitochondrial Function in Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Muscle Metabolism/Mitochondrial Function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Polycystic ovary syndrome
- •No hormonal or antidiabetic medications for 1 month
- •Good general health
排除标准
- •Acute infection or chronic disease
- •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)
研究组 & 干预措施
Metformin
Metformin ER 1500 mg per day treatment for 12 weeks
干预措施: Metformin ER (Drug)
结局指标
主要结局
Muscle Metabolism/Mitochondrial Function
时间窗: 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)
次要结局
- Genetic risk variants affecting mitochondrial function/metabolism(3 months)
研究者
Corrine Welt
Professor of Medicine
Massachusetts General Hospital