The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study

Not Applicable

Completed

• Conditions: Low Water Intake; High Vasopressin

• Registration Number: NCT03574688
• Lead Sponsor: Region Skane

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2017-02-02
• Primary Completion: 2017-07-25
• Study Completion: 2017-07-25
• Status Verified: 2018-06
• Study First Submitted: 2018-06-20
• Study First Submitted QC: 2018-06-20
• Last Update Submitted: 2018-06-30
• Study First Posted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Fasting plasma copeptin concentration (pmol/L)	6 weeks	Change of fasting plasma copeptin between baseline and after 6 weeks of increased water intake.

Secondary Outcome Measures

Name	Time	Method
24 hour urine volume (L/24h)	6 weeks	Change of 24 hour urine volume between baseline and after 6 weeks of increased water intake.
24 hour urine osmolality (mosm/kg H2O)	6 weeks	Change of 24 hour urine osmolality between baseline and after 6 weeks of increased water intake.
Drinking water (L/day)	6 weeks	Change of intake of tap and bottled water between baseline and after 6 weeks of increased water intake.
Total water (L/day)	6 weeks	Change of total water intake between baseline and after 6 weeks of increased water intake.
Fasting plasma glucose concentration (mmol/L)	6 weeks	Change of Fasting plasma glucose concentration between baseline and after 6 weeks of increased water intake.

Trial Locations

Locations (1)

KFE, Skåne University Hospital in Malmö; 🇸🇪 Malmö, Sweden