Clinical trial NCT03574688: The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study
Official title: The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Water Intake
High Vasopressin
Keywords: Hydration
Water
Vasopressin
Copeptin
Glucose
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
name: Danone Global Research & Innovation Center
First posted: 2018-07-02
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants of this pilot intervention study had the intervention of 1.5 Liters of increased daily water intake per day during 6 weeks.
Primary purpose: PREVENTION

Brief summary: This study evaluates increased hydration (1.5 L of water daily during 6 weeks) on top of habitual water intake in the lowering of the vasopressin marker copeptin and in the lowering of plasma glucose concentration in adults with signs of low water intake at recruitment (elevated levels of copeptin, high urine osmolality, low urine volume).

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 a Mendelian randomization study in humans suggest causality between elevated vasopressin concentration and elevated plasma glucose concentration. As vasopressin can be suppressed by increasing water intake, the investigators hypothesize that water supplementation in individuals with high vasopressin can lower plasma glucose and prevent diabetes.

The aim of this pilot study is to test if six weeks of water supplementation of 1.5 Liters of extra water per day in low-drinkers with high copeptin can significantly alter hydration markers in general and reduce plasma copeptin in particular. Furthermore, the investigators also aim at investigating whether this 6-week water intervention can significantly reduce fasting plasma glucose concentration.

Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Age 20-75 years
* High plasma concentration of copeptin of \>6.1 pmol/L in women and \> 10.7 pmol/L in men
* 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 SSRI drugs
* Chronic kidney disease (estimated glomerular filtration rate \< 30mL/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)

Primary outcomes:
measure: Fasting plasma copeptin concentration (pmol/L)
timeFrame: 6 weeks
Secondary outcomes:
measure: 24 hour urine osmolality (mosm/kg H2O)
timeFrame: 6 weeks
measure: 24 hour urine volume (L/24h)
timeFrame: 6 weeks
measure: Drinking water (L/day)
timeFrame: 6 weeks
measure: Total water (L/day)
timeFrame: 6 weeks
measure: Fasting plasma glucose concentration (mmol/L)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: KFE, Skåne University Hospital in Malmö
Study officials:
affiliation: Lund University
name: Olle Melander, M.D., Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Enhorning S, Vanhaecke T, Dolci A, Perrier ET, Melander O. Investigation of possible underlying mechanisms behind water-induced glucose reduction in adults with high copeptin. Sci Rep. 2021 Dec 29;11(1):24481. doi: 10.1038/s41598-021-04224-5.
citation: Enhorning S, Brunkwall L, Tasevska I, Ericson U, Persson Tholin J, Persson M, Lemetais G, Vanhaecke T, Dolci A, Perrier ET, Melander O. Water Supplementation Reduces Copeptin and Plasma Glucose in Adults With High Copeptin: The H2O Metabolism Pilot Study. J Clin Endocrinol Metab. 2019 Jun 1;104(6):1917-1925. doi: 10.1210/jc.2018-02195.