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
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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).
191 studies on the registry are indexed under Diabetes Insipidus; 35 are open to participants now.
This study's enrollment of 797 is above the median of 77 across 118 interventional studies indexed under Diabetes Insipidus.
Browse Diabetes Insipidus studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2018 to primary completion in Dec 2024, 79 months.
Of 37 non-industry interventional studies with no phase under Diabetes Insipidus, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's 79 months is above that.
Counting every sponsor, half of 37 studies reached it within 20 months; a quarter within 8 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Water