Plasma Copeptin in Response to Oral Urea in Healthy Adults and Patients With Polyuria-polydipsia Syndrome: a Double-blind, Randomized, Placebo-controlled Cross-over Proof-of-concept and Pilot Study - The URANOS Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Difference in maximal increase in copeptin levels in plasma (pmol/l)
研究概览
简要总结
The aim of this study is to investigate whether oral urea stimulates copeptin release and, if so, whether it may provide a novel diagnostic test in the differentiation between AVP-D (Arginine vasopressin deficiency) and PP (primary polydipsia).
详细描述
This study consists of two parts, including healthy adults (study part 1 - proof of concept) and adults with an established diagnosis of PP or AVP-D (study part 2 - pilot study).
If the results of study part 1 suggest that oral urea is a potent stimulator of copeptin in healthy adults, study part 2 will be conducted, meaning that adults with an established diagnosis of PP or AVP-D will be included. If study part 1 demonstrates no relevant copeptin increase in response to oral urea, the study will be terminated thereafter and study part 2 will not be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
盲法说明
Study staff and participants are blinded upon the nature of each study visit. The preparation of the study medication or placebo will be performed by unblinded study staff who is otherwise not involved in the trial.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Inclusion Criteria:
- •Age ≥18 years
- •Healthy with no medication except hormonal contraception
排除标准
- •Participation in a trial with investigational drugs within 30 days
- •Evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h
- •Known allergy towards components of the study drink
- •Pregnancy and breastfeeding
- •Intention to become pregnant during the study
- •Evidence of acute illness
- •Inclusion Criteria:
- •Age ≥ 18 years
- •Documented PP or AVP-D based on accepted diagnostic criteria, i.e., water deprivation test, hypertonic saline infusion test or arginine infusion test. Accordingly, patients must have evidence of disordered drinking habits and diuresis defined as polyuria >50ml/kg body weight/24h and polydipsia >3l /24h or must be on regular daily desmopressin medication
- •Exclusion Criteria:
- •Participation in a trial with investigational drugs within 30 days
- •Known allergy towards components of the study drink
- •Pregnancy and breastfeeding
- •Evidence of acute illness
结局指标
主要结局
Difference in maximal increase in copeptin levels in plasma (pmol/l)
时间窗: up to 6 time assessment until 150 minutes after baseline
The difference in maximal increase in copeptin levels in plasma (pmol/l) within 150 minutes after oral intake of urea versus placebo, with the maximal increase being the difference between baseline copeptin values measured at the beginning of the test and maximal values measured between 30 and 150 minutes after ingestion.
次要结局
未报告次要终点