Metabolic Syndrome in PCOS: Precursors and Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI
研究概览
简要总结
The purpose of this study is to investigate the metabolic effects of anti-androgens and oral contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs would produce improvement in metabolic markers in PCOS women and would reduce their long term metabolic risk.
详细描述
Polycystic ovary syndrome (PCOS) is one of the most common conditions of young women, and it is frequently associated with insulin resistance or metabolic syndrome (MBS). In addition, affected women have significantly elevated mean low-density lipoprotein (LDL) levels and an increased prevalence of at risk LDL levels, independent of obesity. We are directly testing the role of androgens in the metabolic abnormalities in PCOS by examining the impact of direct androgen receptor blockade by anti-androgen medications and indirect suppression of androgen production through suppression of leutinizing hormone (LH) with oral contraceptive pills (OCPs), compared with placebo, on visceral adiposity, circulating LDL levels, insulin secretion and sensitivity as measured by frequently-sampled IV glucose tolerance tests (FSIGT) and oral glucose tolerance tests (OGTT), resting energy expenditure, and maximal aerobic capacity measurement.
Note: Originally there were 2 additional study arm, Metformin only and Metformin + Flutamide. These study arms were ultimately eliminated and were not included in analysis of baseline characteristics or endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •6 periods or fewer per year
- •Overweight
- •All ethnicities
排除标准
- •Heart Disease
- •Chronic illness
- •Regular Smokers
- •Current use of Birth Control Pills, Patch, Ring, Depo
研究组 & 干预措施
1
oral contraceptive (35 mg ethinyl estradiol)
干预措施: ethinyl estradiol 35 mcg and drospirenone 3 mg (Drug)
2
Flutamide 250 mg twice daily
干预措施: flutamide (Drug)
3
Placebo
干预措施: placebo (Other)
结局指标
主要结局
Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI
时间窗: 6 months
Change in visceral adipose tissue (VAT) volume as measured by MRI (VAT at study endpoint - baseline VAT)
Change in Low-density Lipoprotein (LDL) Levels Over the Study Period
时间窗: 6 months
Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level)
Change in High-density Lipoprotein (HDL) Levels During Study Period
时间窗: 6 months
Change in high-density lipoprotein (HDL) levels during study period (HDL level at study endpoint - baseline HDL)
Change in Disposition Index
时间窗: 6 months
Change in disposition index (DI, insulin secretion corrected for insulin secretion) as measured by frequently-sampled IV glucose tolerance test (DI at study endpoint - baseline DI)
Change in Resting Energy Expenditure (REE) Over the Study Period
时间窗: 6 months
Change in resting energy expenditure (REE) over the study period (REE at study endpoint - baseline REE)
Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period
时间窗: 6 months
Change in maximal aerobic exercise capacity (VO2 max) over the study period (VO2 max at study endpoint - baseline VO2 max)
Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period
时间窗: 6 months
Change in fat percentage as measured by DEXA scan over the study period (Fat percentage at study endpoint - baseline fat percentage)
次要结局
未报告次要终点
研究者
Andrea Dunaif
Charles F Kettering Professor of Endocrinology & Metabolism Vice Chair for Research, Department of Medicine Northwestern University, Feinberg School of Medicine
Northwestern University