- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03422848
Hydration to Optimize Metabolism (H2O-metabolism)
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Olle Melander, M.D., Prof
- Phone Number: +46 40 391209
- Email: olle.melander@med.lu.se
Study Contact Backup
- Name: Sofia Enhörning, M.D., Ph.D.
- Phone Number: +46 46 172210
- Email: sofia.enhorning@med.lu.se
Study Locations
-
-
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Malmö, Sweden, SE-20502
- Recruiting
- KFE, Skåne University Hospital in Malmö
-
Contact:
- Margaretha M Persson, Ph.D.
- Email: margaretha.m.persson@skane.se
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Contact:
- Olle Melander, M.D., Prof.
- Phone Number: +46 40 391209
- Email: olle.melander@med.lu.se
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Principal Investigator:
- Olle Melander, M.D., Professor
-
Sub-Investigator:
- Sofia Enhörning, M.D., Ph.D.
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Sub-Investigator:
- Irina Tasevska, M.D., Ph.D.
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Water intervention arm
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).
|
Increased daily water intake with 1.5 L of water on top of habitual water intake.
oral and written advice on diet and physical activity
|
Other: Control arm
Control group that will receive general life style advice (general oral and written advice on diet and physical activity).
|
oral and written advice on diet and physical activity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting plasma glucose concentration (mmol/L)
Time Frame: 12 months
|
Difference in change of fasting plasma glucose between water intervention arm and control arm.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetes incidence
Time Frame: 12 months
|
Difference in diabetes incidence between water intervention arm and control arm.
|
12 months
|
Post oral glucose load glucose concentration (mmol/L)
Time Frame: 12 months
|
Difference in change of post oral glucose load glucose concentration (mmol/L) between water intervention arm and control arm
|
12 months
|
Fasting insulin concentration (mIE/L)
Time Frame: 12 months
|
Difference in change of fasting insulin (mIE/L) between water intervention arm and control arm
|
12 months
|
Post oral glucose load insulin concentration (mIE/L)
Time Frame: 12 months
|
Difference in change of post oral glucose load insulin concentration (mIE/L) between water intervention arm and control arm
|
12 months
|
Fasting glucagon concentration (pmol/L)
Time Frame: 12 months
|
Difference in change of fasting glucagon (pmol/L) between water intervention arm and control arm
|
12 months
|
Post oral glucose load glucagon concentration (pmol/L)
Time Frame: 12 months
|
Difference in change of post oral glucose load glucagon concentration (pmol/L) between water intervention arm and control arm
|
12 months
|
HbA1c concentration (mmol/mol)
Time Frame: 12 months
|
Difference in change of HbA1c (mmol/mol) between water intervention arm and control arm
|
12 months
|
Waist circumference (cm)
Time Frame: 12 months
|
Difference in change of waist circumference (cm) between water intervention arm and control arm
|
12 months
|
Body mass index (kg/m^2)
Time Frame: 12 months
|
Difference in change of body mass index (kg/m^2) between water intervention arm and control arm
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12 months
|
Systolic blood pressure (mmHg)
Time Frame: 12 months
|
Difference in change of systolic blood pressure (mmHg) between water intervention arm and control arm
|
12 months
|
Diastolic blood pressure (mmHg)
Time Frame: 12 months
|
Difference in change of diastolic blood pressure (mmHg) between water intervention arm and control arm
|
12 months
|
Triglyceride concentration (mmol/L)
Time Frame: 12 months
|
Difference in change of triglycerides (mmol/L) between water intervention arm and control arm
|
12 months
|
HDL cholesterol concentration (mmol/L)
Time Frame: 12 months
|
Difference in change of HDL cholesterol (mmol/L) between water intervention arm and control arm
|
12 months
|
LDL cholesterol concentration (mmol/L)
Time Frame: 12 months
|
Difference in change of LDL cholesterol (mmol/L) between water intervention arm and control arm
|
12 months
|
Apolipoprotein B concentration (g/L)
Time Frame: 12 months
|
Difference in change of Apolipoprotein B (g/L) between water intervention arm and control arm
|
12 months
|
Apolipoprotein A1 concentration (g/L)
Time Frame: 12 months
|
Difference in change of Apolipoprotein A1 (g/L) between water intervention arm and control arm
|
12 months
|
Urine albumin/creatinine ratio (g/mol)
Time Frame: 12 months
|
Difference in change of urine albumin/creatinine ratio (g/mol) between water intervention arm and control arm
|
12 months
|
Estimated glomerular filtration rate (mL/min/1,73 m2)
Time Frame: 12 months
|
Difference in change of estimated glomerular filtration rate (mL/min/1,73 m2) between water intervention arm and control arm
|
12 months
|
Creatinine clearance (mL/min)
Time Frame: 12 months
|
Difference in change of creatinine clearance (mL/min) between water intervention arm and control arm
|
12 months
|
Fasting cortisol concentration (nmol/L)
Time Frame: 12 months
|
Difference in change of fasting cortisol (nmol/L) between water intervention arm and control arm
|
12 months
|
Fasting adrenocorticotropic hormone concentration (pmol/L)
Time Frame: 12 months
|
Difference in change of fasting adrenocorticotropic hormone (pmol/L) between water intervention arm and control arm
|
12 months
|
C-reactive protein concentration (mg/L)
Time Frame: 12 months
|
Difference in change of C-reactive protein (mg/L) between water intervention arm and control arm
|
12 months
|
Hair cortisol concentration (pg/mg)
Time Frame: 12 months between samplings
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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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting plasma glucose concentration in pre-specified subgroups
Time Frame: 12 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olle Melander, M.D., Prof., Lund University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2016894
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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