The Adrenal Contribution to Androgen Production in Girls During Puberty
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 17-hydroxyprogesterone Response to ACTH
研究概览
简要总结
In girls with elevated androgens the precise source of androgen excess throughout puberty and early adolescence has not been carefully examined. The investigators propose to examine whether the adrenal gland produces the majority of androgens during puberty by studying the differences in androgen responses to adrenocorticotropin hormone (ACTH) administration in normal weight (NW) and obese (OB) girls ages 7-18. The investigators' analyses will compare steroid changes before and 60 min after ACTH administration in NW and OB girls.
详细描述
Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, 0.25 mg adrenocorticotropin hormone (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after Cosyntropin, blood samples will be obtained for repeat hormone measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Normal CBC (Hemoglobin must be at least 11mg/dl)
- •Normal renal and liver function tests (AST& ALT 10-45 IU/L; Albumin 3.3-5 g/dL; Alk phos 30-130 IU/L;
- •direct bili <0.2 mg/dL;
- •total bili <1.2 mg/dL; total protein 6.0-8.0 g/dL) Normal vital signs including normal blood pressure (pulse 60-100/min, respirations 12-20/min, BP 80/60-130/80)
排除标准
- •Pregnancy
- •On oral contraceptives
- •On insulin lowering drugs
- •On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
- •On medications that will influence androgen metabolism or clearance
- •On medications that will inhibit the cytochrome P450 enzyme system (cimetidine, ketoconazole, etc)
- •Subjects with morning cortisol<5 ug/dL will be excluded and asked to see their primary care physician.
- •Subjects with 17-OHP>250 ng/dL) will be excluded and asked to see their primary care physician.
- •Subject with a history of Cushing syndrome or adrenal insufficiency will be excluded
研究组 & 干预措施
Obese group
Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
干预措施: Adrenocorticotropin (Drug)
Obese group
Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
干预措施: Dexamethasone (Drug)
Nonobese group
Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
干预措施: Adrenocorticotropin (Drug)
Nonobese group
Subjects will have blood drawn at 1900 hr for baseline hormone measurements. At 2200 hr each subject will take a single oral dose of dexamethasone at 2200 hr. At 0700 hr the following day, subjects will have a blood sample drawn for hormone measurements. After this blood sample, adrenocorticotropin (ACTH) will be administered as an iv bolus. At 30 and 60 minutes after ACTH, blood samples will be obtained for repeat hormone measurements.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
17-hydroxyprogesterone Response to ACTH
时间窗: 0 and 60 minutes after ACTH administration
17-hyrooxyprogesterone levels before and after ACTH
次要结局
- Free Testosterone Response to ACTH(0 and 60 min after ACTH administration)
- Androstenedione Response to ACTH(0 and 60 min after ACTH administration)
研究者
Jeffrey Chang, MD
Principal Investigator
University of California, San Diego