Effect of Short Term Adrenal Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess (CBS003)
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in free testosterone after ACTH administration before and after hydrocortisone administration for 4 weeks
研究概览
简要总结
Short term hydrocortisone to test whether improves excess androgen production from adrenal gland and ovaries
详细描述
This study will test whether short-term suppression of adrenal function can ameliorate androgen (male hormone) overproduction in overweight girls with androgen excess. The investigators hypothesize that one month of oral hydrocortisone administration will improve androgen levels in girls with adrenal androgen overproduction. Specifically, this intervention will improve androgen levels after adrenal stimulation testing with adrenocorticotropin hormone (ACTH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Overweight(>85th BMI%) females
- •Early to late puberty (expected age range 7-18)
- •Hyperandrogenemic (free testosterone greater than 2.5 standard deviations above the mean for normal control subjects of the same Tanner Stage)
- •Screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated luteinizing hormone (LH), lipids, testosterone, prolactin, DHEAS, E2, glucose, and insulin; and decreased follicle-stimulating hormone (FSH) and/or sex hormone-binding globulin (SHBG)
排除标准
- •Screening labs outside of age-appropriate normal range
- •Hemoglobin <12 mg/dL and hematocrit<36% (Subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. If still <36%, they will be excluded.)
- •Morning Cortisol <5 g/dL
- •17-hydroxyprogesterone >295 ng/dL
- •History of Cushing's syndrome or adrenal insufficiency
研究组 & 干预措施
hydrocortisone
4 weeks hydrocortisone with pre- and post-intervention Dexamethasone and Cosyntropin to perform standardized adrenal stimulation testing
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
Changes in free testosterone after ACTH administration before and after hydrocortisone administration for 4 weeks
时间窗: 30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration
次要结局
- Changes in adrenal steroid precursors after ACTH, baseline, and after 4 weeks of hydrocortisone administration(30 and 60 minutes after ACTH, baseline, and after 4 weeks of hydrocortisone administration)
研究者
Christine Burt Solorzano
Assistant Professor of Pediatrics
University of Virginia