The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Fasting plasma copeptin concentration (pmol/L)
研究概览
简要总结
This study evaluates increased hydration (1.5 L of water daily during 6 weeks) on top of habitual water intake in the lowering of the vasopressin marker copeptin and in the lowering of plasma glucose concentration in adults with signs of low water intake at recruitment (elevated levels of copeptin, high urine osmolality, low urine volume).
详细描述
High plasma concentration of vasopressin (i.e. antidiuretic hormone) is a novel and independent risk factor for type 2 diabetes, the metabolic syndrome, cardiovascular disease and premature death. The main physiological role of vasopressin is to maintain constant plasma osmolality. Previous studies in rats and a Mendelian randomization study in humans suggest causality between elevated vasopressin concentration and elevated plasma glucose concentration. As vasopressin can be suppressed by increasing water intake, the investigators hypothesize that water supplementation in individuals with high vasopressin can lower plasma glucose and prevent diabetes.
The aim of this pilot study is to test if six weeks of water supplementation of 1.5 Liters of extra water per day in low-drinkers with high copeptin can significantly alter hydration markers in general and reduce plasma copeptin in particular. Furthermore, the investigators also aim at investigating whether this 6-week water intervention can significantly reduce fasting plasma glucose concentration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of informed consent
- •Age 20-75 years
- •High plasma concentration of copeptin of >6.1 pmol/L in women and > 10.7 pmol/L in men
- •24-hour urine osmolality > 600 milliosmol (mosm) /kg water.
排除标准
- •24-hour urine volume >1.5 L
- •Pregnancy or breastfeeding
- •Plasma sodium <135 mmol/L
- •Use of diuretics, lithium or SSRI drugs
- •Chronic kidney disease (estimated glomerular filtration rate < 30mL/min)
- •Heart failure
- •Inflammatory bowel disease
- •Type 1 diabetes or type 2 diabetes treated with insulin
- •Vulnerable subjects (subjects with legal guardian, with loss of personal liberty)
研究组 & 干预措施
Water intervention
The participants increase their habitual daily water intake with 1.5 Liters of tap water per day during 6 weeks.
干预措施: Water (Dietary Supplement)
结局指标
主要结局
Fasting plasma copeptin concentration (pmol/L)
时间窗: 6 weeks
Change of fasting plasma copeptin between baseline and after 6 weeks of increased water intake.
次要结局
- 24 hour urine volume (L/24h)(6 weeks)
- 24 hour urine osmolality (mosm/kg H2O)(6 weeks)
- Drinking water (L/day)(6 weeks)
- Total water (L/day)(6 weeks)
- Fasting plasma glucose concentration (mmol/L)(6 weeks)