NCT03574688

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
Last Updated

July 3, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

June 20, 2018

Last Update Submit

June 30, 2018

Conditions

Low Water IntakeHigh Vasopressin

Keywords

HydrationWaterVasopressinCopeptinGlucose

Outcome Measures

Primary Outcomes (1)

  • Fasting plasma copeptin concentration (pmol/L)

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

    6 weeks

Secondary Outcomes (5)

  • 24 hour urine osmolality (mosm/kg H2O)

    6 weeks

  • 24 hour urine volume (L/24h)

    6 weeks

  • Drinking water (L/day)

    6 weeks

  • Total water (L/day)

    6 weeks

  • Fasting plasma glucose concentration (mmol/L)

    6 weeks

Study Arms (1)

Water intervention

EXPERIMENTAL

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

Dietary Supplement: Water

Interventions

WaterDIETARY_SUPPLEMENT

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

Water intervention

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • hour urine osmolality \> 600 milliosmol (mosm) /kg water.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KFE, Skåne University Hospital in Malmö

Malmo, 20502, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 34966186DERIVED

  • 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.

    PMID: 30566641DERIVED

MeSH Terms

Conditions

Diabetes Insipidus

Interventions

Water

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Olle Melander, M.D., Prof

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All participants of this pilot intervention study had the intervention of 1.5 Liters of increased daily water intake per day during 6 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 20, 2018

First Posted

July 2, 2018

Study Start

February 2, 2017

Primary Completion

July 25, 2017

Study Completion

July 25, 2017

Last Updated

July 3, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)