Glucose, High BloodH2O-metabolismNCT03422848
Hydration to Optimize Metabolism
A study testing Water and general life style advice in people with Glucose, High Blood, run by Region Skane at 1 site in Sweden.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose, High Blood
- What is being tested?
- Water and general life style advice
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 797 participants
- Where
- 1 siteSweden
- Study dates
- 24 Apr 2018to 3 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 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).
- Conditions
- Glucose, High Blood
- Being tested
- Water, general life style advice
- Keywords
- hydration, water, vasopressin, copeptin, glucose, OGTT, insulin, glucagon
- Medical subject headings
- Diabetes Insipidus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterDietary supplement
Increased daily water intake with 1.5 L of water on top of habitual water intake.
general life style adviceBehavioural
oral and written advice on diet and physical activity
| Study group | Role | What they receive |
|---|---|---|
| Water intervention arm | Active comparator | 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). Receives: Dietary Supplement: Water; Behavioral: general life style advice |
| Control arm | Other | Control group that will receive general life style advice (general oral and written advice on diet and physical activity). Receives: Behavioral: general life style advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma glucose concentration (mmol/L)
Difference in change of fasting plasma glucose between water intervention arm and control arm.
Measured: 12 months
Secondary outcomes (23)
Diabetes incidence
Difference in diabetes incidence between water intervention arm and control arm.
Measured: 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
Measured: 12 months
Fasting insulin concentration (mIE/L)
Difference in change of fasting insulin (mIE/L) between water intervention arm and control arm
Measured: 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
Measured: 12 months
Fasting glucagon concentration (pmol/L)
Difference in change of fasting glucagon (pmol/L) between water intervention arm and control arm
Measured: 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
Measured: 12 months
HbA1c concentration (mmol/mol)
Difference in change of HbA1c (mmol/mol) between water intervention arm and control arm
Measured: 12 months
Waist circumference (cm)
Difference in change of waist circumference (cm) between water intervention arm and control arm
Measured: 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
Measured: 12 months
Systolic blood pressure (mmHg)
Difference in change of systolic blood pressure (mmHg) between water intervention arm and control arm
Measured: 12 months
Diastolic blood pressure (mmHg)
Difference in change of diastolic blood pressure (mmHg) between water intervention arm and control arm
Measured: 12 months
Triglyceride concentration (mmol/L)
Difference in change of triglycerides (mmol/L) between water intervention arm and control arm
Measured: 12 months
HDL cholesterol concentration (mmol/L)
Difference in change of HDL cholesterol (mmol/L) between water intervention arm and control arm
Measured: 12 months
LDL cholesterol concentration (mmol/L)
Difference in change of LDL cholesterol (mmol/L) between water intervention arm and control arm
Measured: 12 months
Apolipoprotein B concentration (g/L)
Difference in change of Apolipoprotein B (g/L) between water intervention arm and control arm
Measured: 12 months
Apolipoprotein A1 concentration (g/L)
Difference in change of Apolipoprotein A1 (g/L) between water intervention arm and control arm
Measured: 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
Measured: 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
Measured: 12 months
Creatinine clearance (mL/min)
Difference in change of creatinine clearance (mL/min) between water intervention arm and control arm
Measured: 12 months
Fasting cortisol concentration (nmol/L)
Difference in change of fasting cortisol (nmol/L) between water intervention arm and control arm
Measured: 12 months
Fasting adrenocorticotropic hormone concentration (pmol/L)
Difference in change of fasting adrenocorticotropic hormone (pmol/L) between water intervention arm and control arm
Measured: 12 months
C-reactive protein concentration (mg/L)
Difference in change of C-reactive protein (mg/L) between water intervention arm and control arm
Measured: 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.
Measured: 12 months between samplings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start24 Apr 2018
- Primary completion23 Dec 2024
- Study completion3 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose, High BloodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group RCT with two arms during 12 months. Subjects will be randomized to the water-intervention (in total 1.5 L increment daily on the top of habitual intake) and control groups (1:1) by computer-generated block randomization. Both groups will receive general life style advice (general oral and written advice on diet and physical activity).
- Masking
- None (open label)
- Enrolment
- 797 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Danone Global Research & Innovation Center
- Responsible party
- Principal investigator, Olle Melander, Region Skane
- Investigators
- Olle Melander, M.D., Prof., Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422848
- Sponsor's protocol ID
- 2016894
- Acronym
- H2O-metabolism
- Status last verified
- Nov 2025
- First submitted
- 6 Jan 2018
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydration to Optimize Metabolism
- ClinicalTrials.gov ID
- NCT03422848
- Acronym / sponsor ID
- H2O-metabolism / 2016894
- Conditions
- Glucose, High Blood
- Keywords
- hydration, water, vasopressin, copeptin, glucose, OGTT, insulin, glucagon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 797 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Danone Global Research & Innovation Center
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 3 Nov 2025 (actual)
- First posted
- 6 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group RCT with two arms during 12 months. Subjects will be randomized to the water-intervention (in total 1.5 L increment daily on the top of habitual intake) and control groups (1:1) by computer-generated block randomization. Both groups will receive general life style advice (general oral and written advice on diet and physical activity).
| Arm | Type | Receives |
|---|---|---|
| Water intervention arm | Active comparator | Dietary Supplement: Water, Behavioral: general life style adviceThe 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). |
| Control arm | Other | Behavioral: general life style adviceControl group that will receive general life style advice (general oral and written advice on diet and physical activity). |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WaterIncreased daily water intake with 1.5 L of water on top of habitual water intake. | Dietary supplement | Water intervention arm |
| general life style adviceoral and written advice on diet and physical activity | Behavioural | Control arm, Water intervention arm |
Primary outcome
Fasting plasma glucose concentration (mmol/L)
Time frame: 12 months
Difference in change of fasting plasma glucose between water intervention arm and control arm.
23 secondary outcomes
Diabetes incidence
Time frame: 12 months
Post oral glucose load glucose concentration (mmol/L)
Time frame: 12 months
Fasting insulin concentration (mIE/L)
Time frame: 12 months
Post oral glucose load insulin concentration (mIE/L)
Time frame: 12 months
Fasting glucagon concentration (pmol/L)
Time frame: 12 months
Post oral glucose load glucagon concentration (pmol/L)
Time frame: 12 months
HbA1c concentration (mmol/mol)
Time frame: 12 months
Waist circumference (cm)
Time frame: 12 months
Body mass index (kg/m^2)
Time frame: 12 months
Systolic blood pressure (mmHg)
Time frame: 12 months
Diastolic blood pressure (mmHg)
Time frame: 12 months
Triglyceride concentration (mmol/L)
Time frame: 12 months
HDL cholesterol concentration (mmol/L)
Time frame: 12 months
LDL cholesterol concentration (mmol/L)
Time frame: 12 months
Apolipoprotein B concentration (g/L)
Time frame: 12 months
Apolipoprotein A1 concentration (g/L)
Time frame: 12 months
Urine albumin/creatinine ratio (g/mol)
Time frame: 12 months
Estimated glomerular filtration rate (mL/min/1,73 m2)
Time frame: 12 months
Creatinine clearance (mL/min)
Time frame: 12 months
Fasting cortisol concentration (nmol/L)
Time frame: 12 months
Fasting adrenocorticotropic hormone concentration (pmol/L)
Time frame: 12 months
C-reactive protein concentration (mg/L)
Time frame: 12 months
Hair cortisol concentration (pg/mg)
Time frame: 12 months between samplings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olle Melander, M.D., Prof. principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water and general life style advice in people with Glucose, High Blood, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma glucose concentration (mmol/L) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.