An interventional study of Water and general life style advice in Glucose, High Blood, sponsored by Region Skane. Completed at 1 site in Sweden. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Region Skane · Not applicable, Interventional, and Prevention
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.
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).
Exclusion Criteria:
The water intervention group will increase their habitual daily water intake with 1.5 L of tap water. Furthermore they will receive general life style advice (general oral and written advice on diet and physical activity).
Dietary Supplement: Water · Behavioral: general life style advice
Control group that will receive general life style advice (general oral and written advice on diet and physical activity).
Behavioral: general life style advice
Increased daily water intake with 1.5 L of water on top of habitual water intake.
oral and written advice on diet and physical activity
Fasting plasma glucose concentration (mmol/L)
Difference in change of fasting plasma glucose between water intervention arm and control arm.
Time frame: 12 months
Diabetes incidence
Difference in diabetes incidence between water intervention arm and control arm.
Time frame: 12 months
Post oral glucose load glucose concentration (mmol/L)
Difference in change of post oral glucose load glucose concentration (mmol/L) between water intervention arm and control arm
Time frame: 12 months
Fasting insulin concentration (mIE/L)
Difference in change of fasting insulin (mIE/L) between water intervention arm and control arm
Time frame: 12 months
Post oral glucose load insulin concentration (mIE/L)
Difference in change of post oral glucose load insulin concentration (mIE/L) between water intervention arm and control arm
Time frame: 12 months
Fasting glucagon concentration (pmol/L)
Difference in change of fasting glucagon (pmol/L) between water intervention arm and control arm
Time frame: 12 months
Post oral glucose load glucagon concentration (pmol/L)
Difference in change of post oral glucose load glucagon concentration (pmol/L) between water intervention arm and control arm
Time frame: 12 months
HbA1c concentration (mmol/mol)
Difference in change of HbA1c (mmol/mol) between water intervention arm and control arm
Time frame: 12 months
Waist circumference (cm)
Difference in change of waist circumference (cm) between water intervention arm and control arm
Time frame: 12 months
Body mass index (kg/m^2)
Difference in change of body mass index (kg/m\^2) between water intervention arm and control arm
Time frame: 12 months
Systolic blood pressure (mmHg)
Difference in change of systolic blood pressure (mmHg) between water intervention arm and control arm
Time frame: 12 months
Diastolic blood pressure (mmHg)
Difference in change of diastolic blood pressure (mmHg) between water intervention arm and control arm
Time frame: 12 months
Triglyceride concentration (mmol/L)
Difference in change of triglycerides (mmol/L) between water intervention arm and control arm
Time frame: 12 months
HDL cholesterol concentration (mmol/L)
Difference in change of HDL cholesterol (mmol/L) between water intervention arm and control arm
Time frame: 12 months
LDL cholesterol concentration (mmol/L)
Difference in change of LDL cholesterol (mmol/L) between water intervention arm and control arm
Time frame: 12 months
Apolipoprotein B concentration (g/L)
Difference in change of Apolipoprotein B (g/L) between water intervention arm and control arm
Time frame: 12 months
Apolipoprotein A1 concentration (g/L)
Difference in change of Apolipoprotein A1 (g/L) between water intervention arm and control arm
Time frame: 12 months
Urine albumin/creatinine ratio (g/mol)
Difference in change of urine albumin/creatinine ratio (g/mol) between water intervention arm and control arm
Time frame: 12 months
Estimated glomerular filtration rate (mL/min/1,73 m2)
Difference in change of estimated glomerular filtration rate (mL/min/1,73 m2) between water intervention arm and control arm
Time frame: 12 months
Creatinine clearance (mL/min)
Difference in change of creatinine clearance (mL/min) between water intervention arm and control arm
Time frame: 12 months
Fasting cortisol concentration (nmol/L)
Difference in change of fasting cortisol (nmol/L) between water intervention arm and control arm
Time frame: 12 months
Fasting adrenocorticotropic hormone concentration (pmol/L)
Difference in change of fasting adrenocorticotropic hormone (pmol/L) between water intervention arm and control arm
Time frame: 12 months
C-reactive protein concentration (mg/L)
Difference in change of C-reactive protein (mg/L) between water intervention arm and control arm
Time frame: 12 months
Hair cortisol concentration (pg/mg)
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.
Time frame: 12 months between samplings
Fasting plasma glucose concentration in pre-specified subgroups
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.
Time frame: 12 months
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Region Skane