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CompletedNCT03574688H2OMetaboPilotUpdated Jul 3, 2018

The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study

An interventional study of Water in Low Water Intake and High Vasopressin, 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 2018-07-03.

Sponsored by Region Skane · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Feb 2017, registered Jun 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
20 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Low Water Intake
  • High Vasopressin

Keywords

  • Hydration
  • Water
  • Vasopressin
  • Copeptin
  • Glucose
03

In context

Lead sponsor

Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
  • Inflammatory bowel disease
  • Type 1 diabetes or type 2 diabetes treated with insulin
  • Vulnerable subjects (subjects with legal guardian, with loss of personal liberty)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Water intervention

    The participants increase their habitual daily water intake with 1.5 Liters of tap water per day during 6 weeks.

    Dietary Supplement: Water

Interventions

  • Dietary supplementWater

    Increased daily water intake with 1.5 Liters of water per day on top of habitual water intake.

06

What researchers measure

Primary outcomes

  1. Fasting plasma copeptin concentration (pmol/L)

    Change of fasting plasma copeptin between baseline and after 6 weeks of increased water intake.

    Time frame: 6 weeks

Secondary outcomes

  1. 24 hour urine osmolality (mosm/kg H2O)

    Change of 24 hour urine osmolality between baseline and after 6 weeks of increased water intake.

    Time frame: 6 weeks

  2. 24 hour urine volume (L/24h)

    Change of 24 hour urine volume between baseline and after 6 weeks of increased water intake.

    Time frame: 6 weeks

  3. Drinking water (L/day)

    Change of intake of tap and bottled water between baseline and after 6 weeks of increased water intake.

    Time frame: 6 weeks

  4. Total water (L/day)

    Change of total water intake between baseline and after 6 weeks of increased water intake.

    Time frame: 6 weeks

  5. Fasting plasma glucose concentration (mmol/L)

    Change of Fasting plasma glucose concentration between baseline and after 6 weeks of increased water intake.

    Time frame: 6 weeks

07

Study locations

1 site
  • KFE, Skåne University Hospital in Malmö
    Malmö, 20502, Sweden
08

References and documents

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 34966186 ↗
  • Enhorning 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 documents

  • Protocol and statistical analysis plan · Jun 18, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03574688
Lead sponsor
Region Skane
Collaborators
Lund University, Danone Global Research & Innovation Center
Responsible party
Olle Melander (Professor, Region Skane) — Principal investigator
First posted
Jul 2, 2018
Start date
Feb 2, 2017
Primary completion
Jul 25, 2017
Completion
Jul 25, 2017
Last update
Jul 3, 2018

Study contacts

Olle Melander, M.D., Prof
principal investigator · Lund University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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