Hydration to Optimize Metabolism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

797 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-24

Study Completion Date

2025-11-03

Brief Summary

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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.

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Detailed Description

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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

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Glucose, High Blood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Water

Intervention Type DIETARY_SUPPLEMENT

Increased daily water intake with 1.5 L of water on top of habitual water intake.

general life style advice

Intervention Type BEHAVIORAL

oral and written advice on diet and physical activity

Control arm

Control group that will receive general life style advice (general oral and written advice on diet and physical activity).

Group Type OTHER

general life style advice

Intervention Type BEHAVIORAL

oral and written advice on diet and physical activity

Interventions

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Water

Increased daily water intake with 1.5 L of water on top of habitual water intake.

Intervention Type DIETARY_SUPPLEMENT

general life style advice

oral and written advice on diet and physical activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes