Hydration to Optimize Metabolism (H2O-metabolism)

November 15, 2023 updated by: Olle Melander, Region Skane
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.

Study Overview

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 Type

Interventional

Enrollment (Estimated)

760

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Malmö, Sweden, SE-20502
        • Recruiting
        • KFE, Skåne University Hospital in Malmö
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olle Melander, M.D., Professor
        • Sub-Investigator:
          • Sofia Enhörning, M.D., Ph.D.
        • Sub-Investigator:
          • Irina Tasevska, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Water intervention arm
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).
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
Other: Control arm
Control group that will receive general life style advice (general oral and written advice on diet and physical activity).
oral and written advice on diet and physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting plasma glucose concentration (mmol/L)
Time Frame: 12 months
Difference in change of fasting plasma glucose between water intervention arm and control arm.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes incidence
Time Frame: 12 months
Difference in diabetes incidence between water intervention arm and control arm.
12 months
Post oral glucose load glucose concentration (mmol/L)
Time Frame: 12 months
Difference in change of post oral glucose load glucose concentration (mmol/L) between water intervention arm and control arm
12 months
Fasting insulin concentration (mIE/L)
Time Frame: 12 months
Difference in change of fasting insulin (mIE/L) between water intervention arm and control arm
12 months
Post oral glucose load insulin concentration (mIE/L)
Time Frame: 12 months
Difference in change of post oral glucose load insulin concentration (mIE/L) between water intervention arm and control arm
12 months
Fasting glucagon concentration (pmol/L)
Time Frame: 12 months
Difference in change of fasting glucagon (pmol/L) between water intervention arm and control arm
12 months
Post oral glucose load glucagon concentration (pmol/L)
Time Frame: 12 months
Difference in change of post oral glucose load glucagon concentration (pmol/L) between water intervention arm and control arm
12 months
HbA1c concentration (mmol/mol)
Time Frame: 12 months
Difference in change of HbA1c (mmol/mol) between water intervention arm and control arm
12 months
Waist circumference (cm)
Time Frame: 12 months
Difference in change of waist circumference (cm) between water intervention arm and control arm
12 months
Body mass index (kg/m^2)
Time Frame: 12 months
Difference in change of body mass index (kg/m^2) between water intervention arm and control arm
12 months
Systolic blood pressure (mmHg)
Time Frame: 12 months
Difference in change of systolic blood pressure (mmHg) between water intervention arm and control arm
12 months
Diastolic blood pressure (mmHg)
Time Frame: 12 months
Difference in change of diastolic blood pressure (mmHg) between water intervention arm and control arm
12 months
Triglyceride concentration (mmol/L)
Time Frame: 12 months
Difference in change of triglycerides (mmol/L) between water intervention arm and control arm
12 months
HDL cholesterol concentration (mmol/L)
Time Frame: 12 months
Difference in change of HDL cholesterol (mmol/L) between water intervention arm and control arm
12 months
LDL cholesterol concentration (mmol/L)
Time Frame: 12 months
Difference in change of LDL cholesterol (mmol/L) between water intervention arm and control arm
12 months
Apolipoprotein B concentration (g/L)
Time Frame: 12 months
Difference in change of Apolipoprotein B (g/L) between water intervention arm and control arm
12 months
Apolipoprotein A1 concentration (g/L)
Time Frame: 12 months
Difference in change of Apolipoprotein A1 (g/L) between water intervention arm and control arm
12 months
Urine albumin/creatinine ratio (g/mol)
Time Frame: 12 months
Difference in change of urine albumin/creatinine ratio (g/mol) between water intervention arm and control arm
12 months
Estimated glomerular filtration rate (mL/min/1,73 m2)
Time Frame: 12 months
Difference in change of estimated glomerular filtration rate (mL/min/1,73 m2) between water intervention arm and control arm
12 months
Creatinine clearance (mL/min)
Time Frame: 12 months
Difference in change of creatinine clearance (mL/min) between water intervention arm and control arm
12 months
Fasting cortisol concentration (nmol/L)
Time Frame: 12 months
Difference in change of fasting cortisol (nmol/L) between water intervention arm and control arm
12 months
Fasting adrenocorticotropic hormone concentration (pmol/L)
Time Frame: 12 months
Difference in change of fasting adrenocorticotropic hormone (pmol/L) between water intervention arm and control arm
12 months
C-reactive protein concentration (mg/L)
Time Frame: 12 months
Difference in change of C-reactive protein (mg/L) between water intervention arm and control arm
12 months
Hair cortisol concentration (pg/mg)
Time Frame: 12 months between samplings
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.
12 months between samplings

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting plasma glucose concentration in pre-specified subgroups
Time Frame: 12 months
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 diabetes mellitus at baseline, D) men and women separately.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Olle Melander, M.D., Prof., Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

January 6, 2018

First Submitted That Met QC Criteria

January 30, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2016894

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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