Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Hepatic Insulin Sensitivity at Baseline and 6 Months.
研究概览
简要总结
The purpose is to investigate the effects of 2 different treatments (drospirenone/ethinyl estradiol versus rosiglitazone) on insulin sensitivity and androgen levels, inflammatory markers, vascular markers and bone development in overweight adolescent females with polycystic ovary syndrome (PCOS).
详细描述
The purpose of this study is to:
- to compare effects of treatment with drospirenone/ethinyl estradiol (Yasmin)versus rosiglitazone (Avandia) on hyperandrogenism, insulin resistance/hyperinsulinemia, adrenal hyperresponsiveness, body composition, chronic inflammation, bone mass and turnover.
OCPs are the first-line therapy for PCOS, however, they do not address the insulin resistance or the inflammation. Insulin sensitizers have been used successfully to treat PCOS but thiazolidinediones such as rosiglitazone have not been used in adolescents. Therefore we will investigate the effects of treatment with drospirenone/ethinyl estradiol versus rosiglitazone in overweight adolescents with PCOS. We will obtain comprehensive evaluations before and 6 months after randomization, to the respective treatment arms to determine the differences between the 2 treatment modalities.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 10 - 20 years
- •Pubertal level of Tanner stage III-V and menarchal
- •BMI percentile for age and sex greater than or equal to 85%ile
排除标准
- •Oral medications for PCOS, or that have impact on bone (i.e. anti-epileptics)
- •Presence of other diseases, systemic or psychiatric, or chronic medications which could interfere with endocrine function
- •Established diagnosis of diabetes
- •Prior bone surgery, prior osteoporotic fracture, or fracture in the past 12 months
- •Prior thromboembolic event, such as a deep venous thrombosis or pulmonary embolism (PCOS subjects only)
- •Vitamin D deficiency (<10ng/mL)
- •Hyperkalemia (K>5.0 meq/L)
- •Positive pregnancy test (serum)
研究组 & 干预措施
Rosiglitazone
Treatment naive overweight adolescent females with PCOS treated with Rosiglitazone
干预措施: rosiglitazone (Drug)
Drospirenone/ethinyl estradiol
Treatment naive overweight adolescent females with PCOS treated with Drospirenone/ethinyl estradiol
干预措施: drospirenone/ethinyl estradiol (Drug)
结局指标
主要结局
Hepatic Insulin Sensitivity at Baseline and 6 Months.
时间窗: Baseline and 6 months
Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp.
Glucose Tolerance Status at Baseline and 6 Months.
时间窗: Baseline and 6 months
Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria.
Peripheral Insulin Sensitivity at Baseline and 6 Months.
时间窗: Baseline and 6 months
Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp.
次要结局
- LDL at Baseline and 6 Months(Baseline and 6 months)
- Delta Androstenedione at Baseline and 6 Months(Baseline and 6 months)
- Delta DHEA at Baseline and 6 Months(Baseline and 6 months)
- Cholesterol at Baseline and 6 Months(Baseline and 6 months)
- SHBG at Baseline and 6 Months(Baseline and 6 months)
- Delta 17-OHPreg at Baseline and 6 Months(Baseline and 6 months)
- Non-HDL Cholesterol at Baseline and 6 Months(Baseline and 6 months)
- Leptin at Baseline and 6 Months(Baseline and 6 months)
- Total Testosterone at Baseline and 6 Months(Baseline and 6 months)
- Adiponectin at Baseline and 6 Months(Baseline and 6 months)
- Hs-CRP at Baseline and 6 Months(Baseline and 6 months)
- Total Fat Mass at Baseline and 6 Months(Baseline and 6 months)
- Percent Body Fat at Baseline and 6 Months(Baseline and 6 months)
- DHEAS at Baseline and 6 Months(Baseline and 6 months)
- Morning Blood Pressure at Baseline and 6 Months(Baseline and 6 months)
- Free Testosterone at Baseline and 6 Months(Baseline and 6 months)
- Delta 17-OHProg at Baseline and 6 Months(Baseline and 6 months)
- HDL at Baseline and 6 Months(Baseline and 6 months)
- Triglycerides at Baseline and 6 Months(Baseline and 6 months)
- Night Blood Pressure at Baseline and 6 Months(Baseline and 6 months)
研究者
Silva Arslanian
Principal Investigator
University of Pittsburgh