The Effect of Gender on Antidiuresis - Evaluated by Graded Low Dose Desmopressin Infusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Plasma dDAVP
研究概览
简要总结
There is substantial evidence that women throughout life have significantly lower plasma levels of the antidiuretic hormone vasopressin (pAVP) compared to men. The importance of this is not yet fully elucidated, but in relation to the observations of lower pAVP levels, no significant difference in renal response parameters was found. This could be interpreted an increased renal sensitivity in females compared to males. The theory of increased renal sensitivity in females is supported by a few pharmacodynamic studies currently available on this topic. However none of the studies was designed with the purpose of investigate the gender difference.
The aim of this study is to investigate possible gender differences in the renal sensitivity to dDAVP and the effect of age on these differences. This will be done by low dose graded infusion of the synthetic AVP analog dDAVP.
Participants are 80 healthy volunteers equally distributed between four age groups, 8-10 years of age, 16-18 years of age, 25-40 years og age and 65+ years of age.
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
- 8 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal clinical examination
- •Normal residual urine measurements
- •Normal urine dip stick
- •Informed consent by participant or legal guardian
排除标准
- •Smoking, alcohol or drug abuse
- •Conditions of importance to the results (endocrinological, renal or cardial)
- •Current or previous history of incontinence, bedwetting or nocturia
- •Drug use of importance (diuretics, hormone replacement therapy, birth control pills, desmopressin)
- •Pregnancy
- •Allergy towards dDAVP/desmopressin
研究组 & 干预措施
dDAVP infusion
During the 9 hour study period, the subjects will receive three doses of dDAVP infusion (0.0003micrg/kg, 0.0005micrg/kg, 0.004micrg/kg).
干预措施: dDAVP infusion (Drug)
结局指标
主要结局
Plasma dDAVP
时间窗: Plasma concentrations of the synthetic hormone is measured every 90 minutes for the first 8 hours and every half hour, the last hour of the study period
Urine Volume
时间窗: Urine Volume is measured every half hour throughout the 9 hours study period
Urine osmolality
时间窗: Samples for urine osmolality is measured every half hour throughout the 9 hour study period and measured the following day
次要结局
- Plasma sodium(Plasma sodium is measured every 90 minutes throughout the first 8 hours and every half hour in the last hour of the study periode)