Hydration to Optimize Metabolism
- Conditions
- Glucose, High Blood
- Interventions
- Dietary Supplement: WaterBehavioral: general life style advice
- Registration Number
- NCT03422848
- Lead Sponsor
- Region Skane
- Brief 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 760
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Water intervention arm Water The water intervention group will increase their habitual daily water intake with 1.5 L of tap water. Furthermore they will receive general life style advice (general oral and written advice on diet and physical activity). Water intervention arm general life style advice The water intervention group will increase their habitual daily water intake with 1.5 L of tap water. Furthermore they will receive general life style advice (general oral and written advice on diet and physical activity). Control arm general life style advice Control group that will receive general life style advice (general oral and written advice on diet and physical activity).
- Primary Outcome Measures
Name Time Method Fasting plasma glucose concentration (mmol/L) 12 months Difference in change of fasting plasma glucose between water intervention arm and control arm.
- Secondary Outcome Measures
Name Time Method Diabetes incidence 12 months Difference in diabetes incidence between water intervention arm and control arm.
Fasting glucagon concentration (pmol/L) 12 months Difference in change of fasting glucagon (pmol/L) between water intervention arm and control arm
Body mass index (kg/m^2) 12 months Difference in change of body mass index (kg/m\^2) between water intervention arm and control arm
Post oral glucose load glucose concentration (mmol/L) 12 months Difference in change of post oral glucose load glucose concentration (mmol/L) between water intervention arm and control arm
Post oral glucose load insulin concentration (mIE/L) 12 months Difference in change of post oral glucose load insulin concentration (mIE/L) between water intervention arm and control arm
HbA1c concentration (mmol/mol) 12 months Difference in change of HbA1c (mmol/mol) between water intervention arm and control arm
Waist circumference (cm) 12 months Difference in change of waist circumference (cm) between water intervention arm and control arm
Estimated glomerular filtration rate (mL/min/1,73 m2) 12 months Difference in change of estimated glomerular filtration rate (mL/min/1,73 m2) between water intervention arm and control arm
Fasting adrenocorticotropic hormone concentration (pmol/L) 12 months Difference in change of fasting adrenocorticotropic hormone (pmol/L) between water intervention arm and control arm
Fasting insulin concentration (mIE/L) 12 months Difference in change of fasting insulin (mIE/L) between water intervention arm and control arm
Diastolic blood pressure (mmHg) 12 months Difference in change of diastolic blood pressure (mmHg) between water intervention arm and control arm
Post oral glucose load glucagon concentration (pmol/L) 12 months Difference in change of post oral glucose load glucagon concentration (pmol/L) between water intervention arm and control arm
Apolipoprotein A1 concentration (g/L) 12 months Difference in change of Apolipoprotein A1 (g/L) between water intervention arm and control arm
Creatinine clearance (mL/min) 12 months Difference in change of creatinine clearance (mL/min) between water intervention arm and control arm
Systolic blood pressure (mmHg) 12 months Difference in change of systolic blood pressure (mmHg) between water intervention arm and control arm
Triglyceride concentration (mmol/L) 12 months Difference in change of triglycerides (mmol/L) between water intervention arm and control arm
LDL cholesterol concentration (mmol/L) 12 months Difference in change of LDL cholesterol (mmol/L) between water intervention arm and control arm
Urine albumin/creatinine ratio (g/mol) 12 months Difference in change of urine albumin/creatinine ratio (g/mol) between water intervention arm and control arm
C-reactive protein concentration (mg/L) 12 months Difference in change of C-reactive protein (mg/L) between water intervention arm and control arm
Hair cortisol concentration (pg/mg) 12 months between samplings 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.
HDL cholesterol concentration (mmol/L) 12 months Difference in change of HDL cholesterol (mmol/L) between water intervention arm and control arm
Apolipoprotein B concentration (g/L) 12 months Difference in change of Apolipoprotein B (g/L) between water intervention arm and control arm
Fasting cortisol concentration (nmol/L) 12 months Difference in change of fasting cortisol (nmol/L) between water intervention arm and control arm
Trial Locations
- Locations (1)
KFE, Skåne University Hospital in Malmö
🇸🇪Malmö, Sweden