Hydration to Optimize Metabolism

NCT03422848 | Completed DMC

• 1 other identifier: 2016894
• Study Type: interventional
• Target: 797
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glucose, High Blood

Keywords

hydration; water; vasopressin; copeptin; glucose; OGTT; insulin; glucagon

Outcome Measures

Primary Outcomes (1)

• Fasting plasma glucose concentration (mmol/L)

  Difference in change of fasting plasma glucose between water intervention arm and control arm.

  12 months

Secondary Outcomes (23)

• Diabetes incidence

  12 months

• Post oral glucose load glucose concentration (mmol/L)

  12 months

• Fasting insulin concentration (mIE/L)

  12 months

• Post oral glucose load insulin concentration (mIE/L)

  12 months

• Fasting glucagon concentration (pmol/L)

  12 months

Other Outcomes (1)

• Fasting plasma glucose concentration in pre-specified subgroups

  12 months

Study Arms (2)

Water intervention arm

ACTIVE COMPARATOR

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).

Dietary Supplement: Water; Behavioral: general life style advice

Control arm

OTHER

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

Behavioral: general life style advice

Interventions

Water DIETARY_SUPPLEMENT

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

Water intervention arm

general life style advice BEHAVIORAL

oral and written advice on diet and physical activity

Control arm; Water intervention arm

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator
• Danone Global Research & Innovation Center: collaborator

Study Sites (1)

KFE, Skåne University Hospital in Malmö

Malmo, SE-20502, Sweden

Location

MeSH Terms

Conditions

Diabetes Insipidus; Insulin Resistance

Interventions

Water

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Olle Melander, M.D., Prof.

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: January 6, 2018
• First Posted: February 6, 2018
• Study Start: April 24, 2018
• Primary Completion: December 23, 2024
• Study Completion: November 3, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)