The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study

High Vasopressin Clinical Trial

— H2OMetaboPilot  

Official title:

The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03574688
• Other study ID #: 2016894_PILOT
• Status: Completed
• Phase: N/A
• Start date: February 2, 2017
• Est. completion date: July 25, 2017

Study information

• Verified date: June 2018
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 25, 2017
• Est. primary completion date: July 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• High Vasopressin
• Low Water Intake

Intervention

Dietary Supplement:
• Water
Increased daily water intake with 1.5 Liters of water per day on top of habitual water intake.

Locations

Country	Name	City	State
Sweden	KFE, Skåne University Hospital in Malmö	Malmö

Sponsors (3)

Lead Sponsor	Collaborator
Region Skane	Danone Research, Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting plasma copeptin concentration (pmol/L)	Change of fasting plasma copeptin between baseline and after 6 weeks of increased water intake.	6 weeks
Secondary	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
Secondary	24 hour urine volume (L/24h)	Change of 24 hour urine volume between baseline and after 6 weeks of increased water intake.	6 weeks
Secondary	Drinking water (L/day)	Change of intake of tap and bottled water between baseline and after 6 weeks of increased water intake.	6 weeks
Secondary	Total water (L/day)	Change of total water intake between baseline and after 6 weeks of increased water intake.	6 weeks
Secondary	Fasting plasma glucose concentration (mmol/L)	Change of Fasting plasma glucose concentration between baseline and after 6 weeks of increased water intake.	6 weeks