Hydration to Optimize Metabolism

Glucose, High Blood Clinical Trial

— H2O-metabolism  

Official title:

Hydration to Optimize Metabolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03422848
• Other study ID #: 2016894
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Region Skane
• Contact: Olle Melander, M.D., Prof
• Phone: +46 40 391209
• Email: olle.melander[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 760
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• 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 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).

Related Conditions & MeSH terms

• Glucose, High Blood

Intervention

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

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
Other	Fasting plasma glucose concentration in pre-specified subgroups	glucose reduction in A) subjects who remain high in copeptin from population screening to main study baseline, B) subjects with the highest (top tertile) baseline copeptin, C) subjects with diabetes mellitus at baseline, D) men and women separately.	12 months
Primary	Fasting plasma glucose concentration (mmol/L)	Difference in change of fasting plasma glucose between water intervention arm and control arm.	12 months
Secondary	Diabetes incidence	Difference in diabetes incidence between water intervention arm and control arm.	12 months
Secondary	Post oral glucose load glucose concentration (mmol/L)	Difference in change of post oral glucose load glucose concentration (mmol/L) between water intervention arm and control arm	12 months
Secondary	Fasting insulin concentration (mIE/L)	Difference in change of fasting insulin (mIE/L) between water intervention arm and control arm	12 months
Secondary	Post oral glucose load insulin concentration (mIE/L)	Difference in change of post oral glucose load insulin concentration (mIE/L) between water intervention arm and control arm	12 months
Secondary	Fasting glucagon concentration (pmol/L)	Difference in change of fasting glucagon (pmol/L) between water intervention arm and control arm	12 months
Secondary	Post oral glucose load glucagon concentration (pmol/L)	Difference in change of post oral glucose load glucagon concentration (pmol/L) between water intervention arm and control arm	12 months
Secondary	HbA1c concentration (mmol/mol)	Difference in change of HbA1c (mmol/mol) between water intervention arm and control arm	12 months
Secondary	Waist circumference (cm)	Difference in change of waist circumference (cm) between water intervention arm and control arm	12 months
Secondary	Body mass index (kg/m^2)	Difference in change of body mass index (kg/m^2) between water intervention arm and control arm	12 months
Secondary	Systolic blood pressure (mmHg)	Difference in change of systolic blood pressure (mmHg) between water intervention arm and control arm	12 months
Secondary	Diastolic blood pressure (mmHg)	Difference in change of diastolic blood pressure (mmHg) between water intervention arm and control arm	12 months
Secondary	Triglyceride concentration (mmol/L)	Difference in change of triglycerides (mmol/L) between water intervention arm and control arm	12 months
Secondary	HDL cholesterol concentration (mmol/L)	Difference in change of HDL cholesterol (mmol/L) between water intervention arm and control arm	12 months
Secondary	LDL cholesterol concentration (mmol/L)	Difference in change of LDL cholesterol (mmol/L) between water intervention arm and control arm	12 months
Secondary	Apolipoprotein B concentration (g/L)	Difference in change of Apolipoprotein B (g/L) between water intervention arm and control arm	12 months
Secondary	Apolipoprotein A1 concentration (g/L)	Difference in change of Apolipoprotein A1 (g/L) between water intervention arm and control arm	12 months
Secondary	Urine albumin/creatinine ratio (g/mol)	Difference in change of urine albumin/creatinine ratio (g/mol) between water intervention arm and control arm	12 months
Secondary	Estimated glomerular filtration rate (mL/min/1,73 m2)	Difference in change of estimated glomerular filtration rate (mL/min/1,73 m2) between water intervention arm and control arm	12 months
Secondary	Creatinine clearance (mL/min)	Difference in change of creatinine clearance (mL/min) between water intervention arm and control arm	12 months
Secondary	Fasting cortisol concentration (nmol/L)	Difference in change of fasting cortisol (nmol/L) between water intervention arm and control arm	12 months
Secondary	Fasting adrenocorticotropic hormone concentration (pmol/L)	Difference in change of fasting adrenocorticotropic hormone (pmol/L) between water intervention arm and control arm	12 months
Secondary	C-reactive protein concentration (mg/L)	Difference in change of C-reactive protein (mg/L) between water intervention arm and control arm	12 months
Secondary	Hair cortisol concentration (pg/mg)	Difference in change of hair cortisol (pg/mg) between water intervention arm and control arm. Hair cortisol is a measure of chronic stress exposure 3 months prior to sampling.	12 months between samplings