Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 43
- 主要终点
- Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification
研究概览
简要总结
A 24 week study to compare the use of Metformin, birth control pills and a carefully planned intensive lifestyle program that includes weight loss and exercise. These approaches will be compared to placebo (a pill that contains no active substances. Metformin, birth control pills and the lifestyle management program will be used on this research study to compare their ability to:
- reduce fasting glucose levels
- reduce androgen hormone levels
- improve sex steroid binding, and
- improve lipids (fatty substances in the blood)
详细描述
Polycystic ovary syndrome (PCOS) is a condition associated with irregular menstrual cycles, (due to lack of regular ovulation), and evidence of elevated androgen (male hormone) levels, such as unwanted hair growth or acne. This condition often becomes recognized at the time of puberty. The standard treatment for this condition is oral contraceptive pills, which are used not for contraception, but to cause a regular, monthly bleeding pattern.
Many adolescents with PCOS have increased levels of insulin, a hormone that controls the body's sugar balance. These increased insulin levels may play a role in the development of polycystic ovary syndrome. There are several medications now available, which can decrease the insulin levels by improving the action of insulin in the body. Metformin is one of these drugs. Metformin is a drug currently used in the management of diabetes to control blood sugar. It is hoped that by lowering the insulin levels some of the symptoms of polycystic ovary syndrome, such as the lack of regular periods and unwanted hair growth, can be reversed or diminished.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Menstrual irregularity defined as cycle length > 45 days
- •Overweight as BMI > 25
- •Clinical evidence of hirsuitism or acne
- •Testosterone > 50ng/dL
排除标准
- •History of diabetes mellitus
- •History of Cushing's disease
- •History of hyperprolactinemia
- •Untreated hypo or hyperthyroidism
- •History of adrenal hyperplasia
- •Significant renal impairment
- •Received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study
- •Exercise > 10 hours per week
研究组 & 干预措施
1
Metformin
干预措施: Metformin (Drug)
2
Oral Contraceptive Pills
干预措施: Oral Contraceptive Pills (Yasmin) (Drug)
3
lifestyle modification program
干预措施: Lifestyle Modification (Behavioral)
4
placebo to active metformin arm
干预措施: placebo (Drug)
结局指标
主要结局
Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification
时间窗: 24 week
The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY
次要结局
- Weight Loss in Lifestyle Intervention Group(baseline and 24 weeks)
- Change in Fasting Glucose(baseline and 24 weeks)
- Change in Free Androgen Index (FAI)(baseline and 24 weeks)
- Change in SHBG(baseline and 24 weeks)
- Triglyceride Concentration by Treatment Group(baseline and 24 weeks)
研究者
Kathleen M. Hoeger, MD
Professor
University of Rochester