Low Water IntakeH2OMetaboPilotNCT03574688
The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study
A study testing Water in people with Low Water Intake and High Vasopressin, run by Region Skane at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Water Intake, High Vasopressin
- What is being tested?
- Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- 2 Feb 2017to 25 Jul 2017
- 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
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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 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).
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 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.
- Conditions
- Low Water Intake, High Vasopressin
- Being tested
- Water
- Keywords
- Hydration, Water, Vasopressin, Copeptin, Glucose
- Medical subject headings
- Diabetes Insipidus
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 Liters of water per day on top of habitual water intake.
| Study group | Role | What they receive |
|---|---|---|
| Water intervention | Experimental | The participants increase their habitual daily water intake with 1.5 Liters of tap water per day during 6 weeks. Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma copeptin concentration (pmol/L)
Change of fasting plasma copeptin between baseline and after 6 weeks of increased water intake.
Measured: 6 weeks
Secondary outcomes (5)
24 hour urine osmolality (mosm/kg H2O)
Change of 24 hour urine osmolality between baseline and after 6 weeks of increased water intake.
Measured: 6 weeks
24 hour urine volume (L/24h)
Change of 24 hour urine volume between baseline and after 6 weeks of increased water intake.
Measured: 6 weeks
Drinking water (L/day)
Change of intake of tap and bottled water between baseline and after 6 weeks of increased water intake.
Measured: 6 weeks
Total water (L/day)
Change of total water intake between baseline and after 6 weeks of increased water intake.
Measured: 6 weeks
Fasting plasma glucose concentration (mmol/L)
Change of Fasting plasma glucose concentration between baseline and after 6 weeks of increased water intake.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start2 Feb 2017
- Primary completion25 Jul 2017
- Study completion25 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Water IntakeStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants of this pilot intervention study had the intervention of 1.5 Liters of increased daily water intake per day during 6 weeks.
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT03574688
- Sponsor's protocol ID
- 2016894_PILOT
- Acronym
- H2OMetaboPilot
- Status last verified
- Jun 2018
- First submitted
- 20 Jun 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Enhorning S, Vanhaecke T, Dolci A, Perrier ET, Melander O. Investigation of possible underlying mechanisms behind water-induced glucose reduction in adults with high copeptin. Sci Rep. 2021 Dec 29;11(1):24481. doi: 10.1038/s41598-021-04224-5.
PubMed 34966186Enhorning S, Brunkwall L, Tasevska I, Ericson U, Persson Tholin J, Persson M, Lemetais G, Vanhaecke T, Dolci A, Perrier ET, Melander O. Water Supplementation Reduces Copeptin and Plasma Glucose in Adults With High Copeptin: The H2O Metabolism Pilot Study. J Clin Endocrinol Metab. 2019 Jun 1;104(6):1917-1925. doi: 10.1210/jc.2018-02195.
PubMed 30566641
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study
- ClinicalTrials.gov ID
- NCT03574688
- Acronym / sponsor ID
- H2OMetaboPilot / 2016894_PILOT
- Conditions
- Low Water Intake, High Vasopressin
- Keywords
- Hydration, Water, Vasopressin, Copeptin, Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Danone Global Research & Innovation Center
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 25 Jul 2017 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 2 Jul 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 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants of this pilot intervention study had the intervention of 1.5 Liters of increased daily water intake per day during 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Water intervention | Experimental | Dietary Supplement: WaterThe participants increase their habitual daily water intake with 1.5 Liters of tap water per day during 6 weeks. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
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 Liters of water per day on top of habitual water intake. | Dietary supplement | Water intervention |
Primary outcome
Fasting plasma copeptin concentration (pmol/L)
Time frame: 6 weeks
Change of fasting plasma copeptin between baseline and after 6 weeks of increased water intake.
5 secondary outcomes
24 hour urine osmolality (mosm/kg H2O)
Time frame: 6 weeks
24 hour urine volume (L/24h)
Time frame: 6 weeks
Drinking water (L/day)
Time frame: 6 weeks
Total water (L/day)
Time frame: 6 weeks
Fasting plasma glucose concentration (mmol/L)
Time frame: 6 weeks
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 3 Jul 2018.
- Derived from this study: PubMed 34966186Enhorning S, Vanhaecke T, Dolci A, Perrier ET, Melander O. Investigation of possible underlying mechanisms behind water-induced glucose reduction in adults with high copeptin. Sci Rep. 2021 Dec 29;11(1):24481. doi: 10.1038/s41598-021-04224-5.
- Derived from this study: PubMed 30566641Enhorning S, Brunkwall L, Tasevska I, Ericson U, Persson Tholin J, Persson M, Lemetais G, Vanhaecke T, Dolci A, Perrier ET, Melander O. Water Supplementation Reduces Copeptin and Plasma Glucose in Adults With High Copeptin: The H2O Metabolism Pilot Study. J Clin Endocrinol Metab. 2019 Jun 1;104(6):1917-1925. doi: 10.1210/jc.2018-02195.
- Individual participant dataSharing planned: No
Related trials for Low Water Intake
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Dehydrated, Water-Electrolyte Imbalance, Malnutrition, Dehydration (Physiology)
Recruiting
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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 in people with Low Water Intake and High Vasopressin, 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 4 inclusion and 9 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 3 Jul 2018. 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 copeptin concentration (pmol/L) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03574688, which also lists 2 linked publications.
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 3 Jul 2018.