Metabolic Syndrome in PCOS: Precursors and Interventions
关键词
抽象
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.
日期
| 最后验证: | 04/30/2014 |
| 首次提交: | 02/04/2007 |
| 提交的预估入学人数: | 02/28/2007 |
| 首次发布: | 03/01/2007 |
| 上次提交的更新: | 05/08/2014 |
| 最近更新发布: | 06/05/2014 |
| 首次提交结果的日期: | 04/08/2014 |
| 首次提交质量检查结果的日期: | 05/08/2014 |
| 首次发布结果的日期: | 06/05/2014 |
| 实际学习开始日期: | 06/30/2006 |
| 预计主要完成日期: | 10/31/2012 |
| 预计完成日期: | 10/31/2012 |
状况或疾病
干预/治疗
Drug: 2
Drug: 1
Other: 3
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: 1 oral contraceptive (35 mg ethinyl estradiol) | Drug: 1 one active pill per day for three weeks and then 1 sugar pill per day for one week |
| Experimental: 2 Flutamide 250 mg twice daily | Drug: 2 250 mg twice daily |
| Placebo Comparator: 3 Placebo | Other: 3 |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 6 periods or fewer per year - Overweight - All ethnicities Exclusion Criteria: - Diabetes - Heart Disease - Chronic illness - Regular Smokers - Current use of Birth Control Pills, Patch, Ring, Depo |
结果
主要结果指标
1. Change in Low-density Lipoprotein (LDL) Levels Over the Study Period [6 months]
2. Change in High-density Lipoprotein (HDL) Levels During Study Period [6 months]
3. Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI [6 months]
4. Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period [6 months]
5. Change in Disposition Index [6 months]
6. Change in Resting Energy Expenditure (REE) Over the Study Period [6 months]
7. Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period [6 months]
