Sexually Dimorphic Effects of GHRH in Adult Growth Hormone Testing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Serum GH levels in response to GHRH/arginine stimulation
研究概览
简要总结
Specific Aim 1 Healthy male and female subjects and growth hormone (GH) deficient subjects display sexually dimorphic GH responses to GHRH administration
Specific Aim 2 GH responses to GHRH in both healthy controls and in GH deficient patients correlate with expression and activity of the stimulatory G proteins, G alpha q and G alpha S. G protein levels correlate with gonadal steroid levels.
Specific Aim 3 Sexually dimorphic GH responses to GHRH are enhanced in Tanner Stage V compared to Tanner Stage 1 individuals
详细描述
Growth hormone deficiency affects disproportionately more males than females. Although ascertainment bias plays a role in this sexual dimorphism, no plausible mechanism to fully explain this difference has been proposed.
This investigator initiated study will provide currently unavailable data on sexual/age differences in response to GH stimulation testing. Data obtained from the study may provide a basis for developing appropriate normal ranges for adult GH testing, may provide a plausible mechanism for the enhanced hormone responsiveness observed in females, and may provide data on when the sexual differences to GH stimulation may develop.
The objectives of this study are to:
- Confirm the sexual dimorphism in growth hormone responses for adult growth hormone testing in healthy male and female subjects
- Correlate peak Growth Hormone Releasing Hormone (GHRH)/arginine induced growth hormone responses with G protein levels in healthy subjects and in patients with a history of childhood GH deficiency
- Determine whether sexual dimorphism is acquired during puberty
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
- 5 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Males and females, Tanner stage V aged 15-40 years of age with no known endocrine problems
- •Males and females, Tanner stage I, aged 5-8 years with no known endocrine problems
- •GH subjects - Males and females, Tanner stage V, aged 15-21 years with a history of childhood growth hormone deficiency
排除标准
- •Healthy subjects
- •History of GH deficiency or treatment or other known endocrine disorder
- •Current height or adult height <5th %
- •Female subjects using hormonal methods of birth control
- •Female subjects with irregular menstrual cycles
- •GH subjects
- •- Subjects with GH deficiency who have not discontinued GH treatment for at least 2 months
结局指标
主要结局
Serum GH levels in response to GHRH/arginine stimulation
时间窗: End of study
次要结局
- mRNA and protein levels of G alpha q and G alpha S stimulatory proteins(end of study)
- Serum gonadal steroid levels in the three subject groups(end of study)