Novel Extragonadal Effects of Human Chorion Gonadotropin (hCG) on Calcium Homeostasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Serum calcium
研究概览
简要总结
A pilot study showed that serum calcium levels and calcium homeostasis change in response to hCG stimulation test. Serum calcium level differed when comparing pretreatment values at baseline with serum levels 72 hours after hCG stimulation in men with gonadal insufficiency referred for this stimulation test. Now we want to investigate whether this change in calcium is due to renal loss or other mechanisms and how the classical regulators of calcium homeostasis respond to hCG in men with impaired gonadal function compared with men having normal gonadal function. Moreover, the observed change in serum calcium implies that hCG also changes Phosphate, PTH and calcitonin and this will be clarified with this study
详细描述
Aim To investigate whether human chorionic gonadotropin (hCG) stimulation test changes calcium-phosphate homeostasis in men with normal and impaired testicular function.
The overall purpose of the project is to investigate the importance of human chorion gonadotropin (hCG) for the calcium balance in normal men and men with impaired testicular function.
BACKGROUND AND HYPOTHESES
The Department for Growth and Reproduction has helped to uncover the rising occurrence of early puberty, infertility, polycystic ovarian syndrome and testicular cancer that is worryingly high in large numbers parts of the world (1). These conditions are all governed by the hormonal axis that contains hypothalamus, pituitary gland, and the HPG axis (2). Our hypothesis is, that hCG may be a new regulator of calcium balance. hCG acts like luteinizing hormone (LH) produced by the pituitary gland and stimulates by binding to the LH receptor (LHCGR) production of testosterone in the testicles (3-6). we and others have found that that LHCGR is also located in other tissues than the gonad (7) and we suggest that LH stimulation probably also regulates calcium handling in the kidney. We have observed changes in serum calcium after hCG injection in patients with impaired testicular function, which indicates that the gonads and gonadotropins may be important for calcium and phosphate homeostasis. It is compatible with the fact that it has been shown that ex FSH can regulate bone function (8),and sex hormones are important for calcium absorption and excretion in the kidney (9-11). The latter is interesting because our research suggests that the receptor for the luteinizing hormone and hCG (LHCGR) plays an important role in the kidney, thus enabling a direct effect on calcium and phosphate handling for LHCGR agonists such as LH and hCG.
With this study we want to investigate how hCG influences calcium homeostasis and subsequently other extragonadal organs by analyzing serum and urine from men with normal and impaired gonadal function
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •to be either
- •a man with normal reproductive function
- •or a man with known impaired gonadal function
- •more than 18 years of age and less than 80 years of age
排除标准
- •presence of current serious diseases
- •or presence of disease requiring constant and lifelong treatment with chemotherapy or other toxic drugs
- •Men treated with testosterone who do not stop their treatment while being part of the study,
研究组 & 干预措施
human chorion gonadotropin
Pregnyl, hCG, 5000 IU times one im.
干预措施: human chorionic gonadotropin (Drug)
结局指标
主要结局
Serum calcium
时间窗: 2,8,24, 72,120 hours
changes albumin corrected calcium, ionized calcium, total calcium
次要结局
- urinary calcium and phosphate excretion(2,8,24, 72,120 hours)
- serum Phosphate(2,8,24, 72,120 hours)
研究者
Martin Blomberg Jensen
Group leader, MD, DMSc
Rigshospitalet, Denmark