Trials / Completed
CompletedNCT03422848
Hydration to Optimize Metabolism
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 797 (actual)
- Sponsor
- Region Skane · Academic / Other
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Accepted
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.
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Water | Increased daily water intake with 1.5 L of water on top of habitual water intake. |
| BEHAVIORAL | general life style advice | oral and written advice on diet and physical activity |
Timeline
- Start date
- 2018-04-24
- Primary completion
- 2024-12-23
- Completion
- 2025-11-03
- First posted
- 2018-02-06
- Last updated
- 2025-12-02
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT03422848. Inclusion in this directory is not an endorsement.