DIETARY_SUPPLEMENT
Water
Increased daily water intake with 1.5 L of water on top of habitual water intake.
Status
Completed
Phase
Not applicable
Enrollment
797
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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).
Interventions
Treatment arms and agents.
BEHAVIORAL
general life style advice
oral and written advice on diet and physical activity
Timeline
From registration to results.
First posted
Feb 6, 2018
Study start
Apr 24, 2018
Primary completion
Dec 23, 2024
Study completion
Nov 3, 2025
Results posted
Not reported
Registry updated
Dec 2, 2025
Outcomes
What the study measures.
Primary outcomes
Fasting plasma glucose concentration (mmol/L)
Time frame · 12 months
Difference in change of fasting plasma glucose between water intervention arm and control arm.
Secondary outcomes
Diabetes incidence
Time frame · 12 months
Difference in diabetes incidence between water intervention arm and control arm.
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
Fasting insulin concentration (mIE/L)
Time frame · 12 months
Difference in change of fasting insulin (mIE/L) between water intervention arm and control arm
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
Fasting glucagon concentration (pmol/L)
Time frame · 12 months
Difference in change of fasting glucagon (pmol/L) between water intervention arm and control arm
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
HbA1c concentration (mmol/mol)
Time frame · 12 months
Difference in change of HbA1c (mmol/mol) between water intervention arm and control arm
Waist circumference (cm)
Time frame · 12 months
Difference in change of waist circumference (cm) between water intervention arm and control arm
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
Systolic blood pressure (mmHg)
Time frame · 12 months
Difference in change of systolic blood pressure (mmHg) between water intervention arm and control arm
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- Yes
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 locations
1 registered sites.
Sweden. Showing up to 24 locations stored in the fast local snapshot.
KFE, Skåne University Hospital in Malmö
Malmö, Sweden
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Vasopressin.
NCT IDStudyPhase / statusEnrollmentUpdated
Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort Study
First Affiliated Hospital, Sun Yat-Sen University · Liver Neoplasms · Postoperative Complications
Not applicable
Completed
161
2026-07
Mifepristone vs Misoprostol
Montefiore Medical Center · Cervical Preparation
Phase 1
Recruiting
94
2026-07
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Elizabeth Austen Lawson · Vasopressin Deficiency
Phase 1
Recruiting
40
2026-07
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Massachusetts General Hospital · Arginine Vasopressin Deficiency · Oxytocin Deficiency
Early Phase 1
Recruiting
20
2026-07
Randomized Controlled Clinical Study on the Prophylactic Intraoperative Use of Desmopressin in Complex Sellar Region Tumors
Zhaoyun Zhang · Craniopharyngiomas · Pituitary Macroadenoma
Phase 4
Enrolling by invitation
152
2026-07
"SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia
Otsuka Pharmaceutical Development & Commercialization, Inc. · Hyponatremias · Water Intoxication
Phase 3
Completed
205
2026-07
Study of Ascending Levels of Tolvaptan in Hyponatremia
Otsuka Pharmaceutical Development & Commercialization, Inc. · Hyponatremia
Phase 3
Completed
243
2026-07
Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation
Beijing Friendship Hospital · Kidney Transplant · Delayed Graft Function
Not applicable
Active, not recruiting
150
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.