The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study (H2OMetaboPilot)

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).

Study Overview

• Status: Completed
• Conditions: Low Water Intake; High Vasopressin
• Intervention / Treatment: Dietary supplement: Water

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, 20502
    • KFE, Skåne University Hospital in Malmö

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Water intervention; The participants increase their habitual daily water intake with 1.5 Liters of tap water per day during 6 weeks.	Dietary supplement: Water; Increased daily water intake with 1.5 Liters of water per day on top of habitual water intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting plasma copeptin concentration (pmol/L)	Change of fasting plasma copeptin between baseline and after 6 weeks of increased water intake.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 hour urine osmolality (mosm/kg H2O)	Change of 24 hour urine osmolality between baseline and after 6 weeks of increased water intake.	6 weeks
24 hour urine volume (L/24h)	Change of 24 hour urine volume between baseline and after 6 weeks of increased water intake.	6 weeks
Drinking water (L/day)	Change of intake of tap and bottled water between baseline and after 6 weeks of increased water intake.	6 weeks
Total water (L/day)	Change of total water intake between baseline and after 6 weeks of increased water intake.	6 weeks
Fasting plasma glucose concentration (mmol/L)	Change of Fasting plasma glucose concentration between baseline and after 6 weeks of increased water intake.	6 weeks

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Lund University; Danone Research
• Investigators: Principal Investigator: Olle Melander, M.D., Prof, Lund University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2017
• Primary Completion (Actual): July 25, 2017
• Study Completion (Actual): July 25, 2017

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: June 30, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Hydration; Vasopressin; Glucose; Copeptin; Water
• Other Study ID Numbers: 2016894_PILOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No