Calciotropic Effects After HCG Stimulation Test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 2
- 主要终点
- change in total, albumin corrected or ionized calcium
研究概览
简要总结
We have in a pilot study found that serum calcium levels change in response to hCG stimulation test. We observed that serum calcium level measured at baseline and 72 hours after hCG stimulation were different in men with gonadal insufficiency referred for this stimulation test. Now we want to investigate a large cohort of men referred for hCG stimulation test due to suspected impaired gonadal function.
详细描述
Introduction:
hCG signals through the LHCGR receptor and is know to stimulate testosterone production. hCG stimulation tests are therefore used to evaulate the capacity of the testis to respond to LH/hCG and thereby determine the degree og gonadal insufficiency and need for testosterone supplementation. Some groups have found LHCRG in extragondal tissues indicating a direct effect of hCG/LH outside the gonads. We noticed that some men with gonadal insuffciency had a low calcium level after hCG stimulation test. Now we would like to investigate whether this putative effect on calcium homeostasis of hCG is due to a direct effect or an indirect effect through testosterone or other sex steroids that also change in response to hCG stimulation. Moreover, we would like to clarify whether the chnage in calcium is compensated by classical regulators such as PTH, 1,25OH2D3, calcitonin, phosphate, CTX, alkaline phosphatase or other factors.
Aim of study:
The purpose of this study is to describe changes in calcium and calciotropic hormones after hCG stimulation test
DESIGN This is a prospective observational study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •men aged 18-60 years referred for hCG stimulation test due to previous treatment for testis cancer
排除标准
- •high intake calcium
- •know disorders in calcium homeostasis
研究组 & 干预措施
hypogondal men
men referred for hCG stimulation test
干预措施: human chorionic gonadotropin (Drug)
结局指标
主要结局
change in total, albumin corrected or ionized calcium
时间窗: 72 and 96 hours after hCG injection
mmol/l
次要结局
- 1,25OH2D3(72 and 96 hours after hCG injection)
- total and free estradiol(72 and 96 hours after hCG injection)
- kidney function(72 and 96 hours after hCG injection)
- cortisol(72 and 96 hours after hCG injection)
- total and free testosterone(72 and 96 hours after hCG injection)
- 25OHD or 24,25OH2D3(72 and 96 hours after hCG injection)
- LHCGR(72 and 96 hours after hCG injection)
- PTH(72 and 96 hours after hCG injection)
- Phosphate(72 and 96 hours after hCG injection)
- albumin, Shbg, VDBP(72 and 96 hours after hCG injection)
- bone factors such as CTX, osteocalcin, RANKL, FGF23(72 and 96 hours after hCG injection)
研究者
Martin Blomberg Jensen
MD, group leader
Rigshospitalet, Denmark