Diagnosis of Adult Growth Hormone Deficiency With Growth Hormone Releasing Hormone Plus Arginine Stimulation Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Peak serum GH (ug/l) by Immulite 2000 Xpi
研究概览
简要总结
The purpose of this study was to validate the growth hormone releasing hormone (GHRH) plus arginine (GHRH+arg) stimulation test and it´s cut-off limits for diagnosis of adult growth hormone deficiency using the growth hormone (GH) Immulite 2000 Xpi assay calibrated against the IS 98/574 from the World Health Organization. A specific aim was to study the effect of gender and age on the peak GH response in the GHRH+arg test
详细描述
Adult growth hormone deficiency (AGHD) is a clinical entity including increased abdominal fat mass, decreased muscle mass, low bone density and adverse effects on quality of life and cardiovascular morbidity. These signs are nonspecific, and accurate diagnosis with laboratory tests in needed.
The GHRH+arg test is used to diagnose AGHD, but the cut-off values vary based on controls used. At moment consensus cut-off criteria are BMI specific, but gender and age may also affect the GH response in the GHRH+arg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for health patients:
- •age 20-60 years,
- •no symptoms indicative of disease.
- •for patients:
- •age 16-90 years
- •previous pituitary disease
- •suspicion of growth hormone deficiency
排除标准
- •for healthy controls:
- •a known or suspected disease,
- •any symptoms indicating disease
- •use of medication
结局指标
主要结局
Peak serum GH (ug/l) by Immulite 2000 Xpi
时间窗: one year
次要结局
- Serum insulin like growth hormone 1 (IGF-1) concentration(one year)
- Basal serum GH (ug/l) by Immulite 2000 Xpi(one year)
研究者
tuula pekkarinen
consulting endocrinologist
Helsinki University Central Hospital