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NCT Number: NCT03422848

Hydration to Optimize Metabolism

This study evaluates hydration (1.5 L of water daily during 1 year) in the lowering of blood glucose concentration in adults with signs of dehydration (elevated levels of the vasopressin marker copeptin and high urine osmolality). Half of participants will in addition to lifestyle advice receive extra water on top of their habitual fluid intake, and the other half (control) will receive only lifestyle advice.

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Key information

Conditions

Glucose, High Blood Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KFE, Skåne University Hospital in Malmö

Malmö, SE-20502, Sweden

About this study

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 mendelian randomization studies in humans suggest causality between elevated vasopressin concentration and elevated plasma glucose concentration. As vasopressin can be suppressed by increasing water intake, we hypothesize that water supplementation in individuals with high vasopressin can lower plasma glucose and prevent diabetes.

The aim of this project is to test in a single-centre randomized clinical trial (RCT), if water supplementation in subjects with high plasma levels of vasopressin (measured by a stable vasopressin marker of its precursor hormone called copeptin) can reduce fasting levels of glucose (primary outcome measure), risk of new-onset diabetes and other cardiometabolic risk factors (secondary outcome measures).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of informed consent, age 20-75 years with high plasma concentration of vasopressin (plasma concentration of copeptin of > 6.1 pmol/L in women and > 10.7 pmol/L in men) and 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 selective serotonin reuptake inhibitor (SSRI) drugs, chronic kidney disease (estimated glomerular filtration rate < 30 mL/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).

Treatment and study plan

Water

Dietary Supplement

Increased daily water intake with 1.5 L of water on top of habitual water intake.

general life style advice

Behavioral

oral and written advice on diet and physical activity

Primary outcomes

  1. Fasting plasma glucose concentration (mmol/L)

    Time frame: 12 months

    Difference in change of fasting plasma glucose between water intervention arm and control arm.

Secondary outcomes

  1. Diabetes incidence

    Time frame: 12 months

    Difference in diabetes incidence between water intervention arm and control arm.

  2. Post oral glucose load glucose concentration (mmol/L)

    Time frame: 12 months

    Difference in change of post oral glucose load glucose concentration (mmol/L) between water intervention arm and control arm

  3. Fasting insulin concentration (mIE/L)

    Time frame: 12 months

    Difference in change of fasting insulin (mIE/L) between water intervention arm and control arm

  4. Post oral glucose load insulin concentration (mIE/L)

    Time frame: 12 months

    Difference in change of post oral glucose load insulin concentration (mIE/L) between water intervention arm and control arm

  5. Fasting glucagon concentration (pmol/L)

    Time frame: 12 months

    Difference in change of fasting glucagon (pmol/L) between water intervention arm and control arm

  6. Post oral glucose load glucagon concentration (pmol/L)

    Time frame: 12 months

    Difference in change of post oral glucose load glucagon concentration (pmol/L) between water intervention arm and control arm

  7. HbA1c concentration (mmol/mol)

    Time frame: 12 months

    Difference in change of HbA1c (mmol/mol) between water intervention arm and control arm

  8. Waist circumference (cm)

    Time frame: 12 months

    Difference in change of waist circumference (cm) between water intervention arm and control arm

  9. Body mass index (kg/m^2)

    Time frame: 12 months

    Difference in change of body mass index (kg/m^2) between water intervention arm and control arm

  10. Systolic blood pressure (mmHg)

    Time frame: 12 months

    Difference in change of systolic blood pressure (mmHg) between water intervention arm and control arm

  11. Diastolic blood pressure (mmHg)

    Time frame: 12 months

    Difference in change of diastolic blood pressure (mmHg) between water intervention arm and control arm

  12. Triglyceride concentration (mmol/L)

    Time frame: 12 months

    Difference in change of triglycerides (mmol/L) between water intervention arm and control arm

  13. HDL cholesterol concentration (mmol/L)

    Time frame: 12 months

    Difference in change of HDL cholesterol (mmol/L) between water intervention arm and control arm

  14. LDL cholesterol concentration (mmol/L)

    Time frame: 12 months

    Difference in change of LDL cholesterol (mmol/L) between water intervention arm and control arm

  15. Apolipoprotein B concentration (g/L)

    Time frame: 12 months

    Difference in change of Apolipoprotein B (g/L) between water intervention arm and control arm

  16. Apolipoprotein A1 concentration (g/L)

    Time frame: 12 months

    Difference in change of Apolipoprotein A1 (g/L) between water intervention arm and control arm

  17. Urine albumin/creatinine ratio (g/mol)

    Time frame: 12 months

    Difference in change of urine albumin/creatinine ratio (g/mol) between water intervention arm and control arm

  18. Estimated glomerular filtration rate (mL/min/1,73 m2)

    Time frame: 12 months

    Difference in change of estimated glomerular filtration rate (mL/min/1,73 m2) between water intervention arm and control arm

  19. Creatinine clearance (mL/min)

    Time frame: 12 months

    Difference in change of creatinine clearance (mL/min) between water intervention arm and control arm

  20. Fasting cortisol concentration (nmol/L)

    Time frame: 12 months

    Difference in change of fasting cortisol (nmol/L) between water intervention arm and control arm

  21. Fasting adrenocorticotropic hormone concentration (pmol/L)

    Time frame: 12 months

    Difference in change of fasting adrenocorticotropic hormone (pmol/L) between water intervention arm and control arm

  22. C-reactive protein concentration (mg/L)

    Time frame: 12 months

    Difference in change of C-reactive protein (mg/L) between water intervention arm and control arm

  23. Hair cortisol concentration (pg/mg)

    Time frame: 12 months between samplings

    Difference in change of hair cortisol (pg/mg) between water intervention arm and control arm. Hair cortisol is a measure of chronic stress exposure 3 months prior to sampling.

Other outcomes

  1. Fasting plasma glucose concentration in pre-specified subgroups

    Time frame: 12 months

    glucose reduction in A) subjects who remain high in copeptin from population screening to main study baseline, B) subjects with the highest (top tertile) baseline copeptin, C) subjects with/without diabetes mellitus at baseline, D) subjects with/without impaired fasting glucose (diabetes+impaired/not impaired), E) men and women separately.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Danone Global Research & Innovation Center
  • Lund University

Registry information

Acronym: H2O-metabolism

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Feb 6, 2018
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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