Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome. A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Hepatic adiposity as assessed using MRI
研究概览
简要总结
This is a prospective randomized, double-blind placebo-controlled trial of 6 months' duration evaluating the effect of fenofibrate (200 mg/day) in females with polycystic ovary syndrome and mild hypertriglyceridemia. The investigators primary objective will be to determine whether fenofibrate will reduce hepatic adiposity as measured using MRI, and our secondary outcomes will be to delineate the impact of fenofibrate on biochemical or clinical parameters for insulin resistance, cardiovascular disease, and reproductive status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •premenopausal women ≥ 18 years
- •diagnosis of PCOS based on the recent 2006 Androgen Excess Society criteria (modified from Rotterdam 2003)
- •waist circumference >88 cm
- •fasting TG 2.0 - 5.0 mmol/L
- •stable on any type of oral contraceptive for a minimum of 3-months
排除标准
- •known contraindications for MRI
- •pregnancy, lactation, desire to become pregnant
- •participation in another clinical trial
- •fasting TF level ≥ 5.0 mmol/L
- •AST or ALT > 2.5 times upper limit of normal (ULN)
- •creatinine kinase (CK) > 6x ULN
- •creatinine > 115 μmol/L
- •fasting glucose ≥ 7.0 mmol/L and/or 2h glucose post oral glucose tolerance test (OGTT) ≥ 11.1 mmol/L or personal history of DM2
- •personal history of renal disease, liver disease (except NAFLD), or heart disease
- •body mass index (BMI) < 18 or > 40 kg/m²
- •increased alcohol use (>9 standard drinks per week [standard drink = 12oz beer, 5oz wine, or 1.5oz spirits]) or drug use
- •use of other hormonal contraception, growth hormone, glucocorticoids, anti-diabetic/anti-dyslipidemia medications, or anabolic steroids.
研究组 & 干预措施
2
Placebo match for 6 months
干预措施: Placebo (Other)
1
fenofibrate 200mg/daily for 6 months
干预措施: Fenofibrate (Drug)
结局指标
主要结局
Hepatic adiposity as assessed using MRI
时间窗: 6-months
次要结局
- Body composition using bioelectrical impedance analysis (BIA), anthropometry (skin-fold thickness measurement), and MRI(6-months)
- Biochemical parameters related to insulin resistance (adipocytokines, free fatty acids, 25-hydroxyvitamin D)(6 months)
- Insulin resistance using HOMA-IR(6 months)
- Traditional and non-traditional cardiovascular risk factors (lipids, apolipoproteins, fibrinogen, PAI-1, CRP)(6 months)
- Reproductive parameters (androgens, hirsutism)(6 months)
研究者
Tisha Joy
Assistant Professor, Division of Endocrinology
Lawson Health Research Institute