Hydration to Optimize Metabolism (H2O-metabolism)
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ClinicalTrials.gov Identifier: NCT03422848 |
Recruitment Status :
Recruiting
First Posted : February 6, 2018
Last Update Posted : November 18, 2023
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Condition or disease | Intervention/treatment | Phase |
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Glucose, High Blood | Dietary Supplement: Water Behavioral: general life style advice | Not Applicable |
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 : | Interventional (Clinical Trial) |
Estimated Enrollment : | 760 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel-group RCT with two arms during 12 months. Subjects will be randomized to the water-intervention (in total 1.5 L increment daily on the top of habitual intake) and control groups (1:1) by computer-generated block randomization. Both groups will receive general life style advice (general oral and written advice on diet and physical activity). |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Hydration to Optimize Metabolism |
Actual Study Start Date : | April 24, 2018 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | June 30, 2025 |
Arm | Intervention/treatment |
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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).
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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 |
Control arm
Control group that will receive general life style advice (general oral and written advice on diet and physical activity).
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Behavioral: general life style advice
oral and written advice on diet and physical activity |
- Fasting plasma glucose concentration (mmol/L) [ Time Frame: 12 months ]Difference in change of fasting plasma glucose between water intervention arm and control arm.
- Diabetes incidence [ Time Frame: 12 months ]Difference in diabetes incidence between water intervention arm and control arm.
- 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
- Fasting insulin concentration (mIE/L) [ Time Frame: 12 months ]Difference in change of fasting insulin (mIE/L) between water intervention arm and control arm
- 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
- Fasting glucagon concentration (pmol/L) [ Time Frame: 12 months ]Difference in change of fasting glucagon (pmol/L) between water intervention arm and control arm
- 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
- HbA1c concentration (mmol/mol) [ Time Frame: 12 months ]Difference in change of HbA1c (mmol/mol) between water intervention arm and control arm
- Waist circumference (cm) [ Time Frame: 12 months ]Difference in change of waist circumference (cm) between water intervention arm and control arm
- 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
- Systolic blood pressure (mmHg) [ Time Frame: 12 months ]Difference in change of systolic blood pressure (mmHg) between water intervention arm and control arm
- Diastolic blood pressure (mmHg) [ Time Frame: 12 months ]Difference in change of diastolic blood pressure (mmHg) between water intervention arm and control arm
- Triglyceride concentration (mmol/L) [ Time Frame: 12 months ]Difference in change of triglycerides (mmol/L) between water intervention arm and control arm
- HDL cholesterol concentration (mmol/L) [ Time Frame: 12 months ]Difference in change of HDL cholesterol (mmol/L) between water intervention arm and control arm
- LDL cholesterol concentration (mmol/L) [ Time Frame: 12 months ]Difference in change of LDL cholesterol (mmol/L) between water intervention arm and control arm
- Apolipoprotein B concentration (g/L) [ Time Frame: 12 months ]Difference in change of Apolipoprotein B (g/L) between water intervention arm and control arm
- Apolipoprotein A1 concentration (g/L) [ Time Frame: 12 months ]Difference in change of Apolipoprotein A1 (g/L) between water intervention arm and control arm
- 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
- 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
- Creatinine clearance (mL/min) [ Time Frame: 12 months ]Difference in change of creatinine clearance (mL/min) between water intervention arm and control arm
- Fasting cortisol concentration (nmol/L) [ Time Frame: 12 months ]Difference in change of fasting cortisol (nmol/L) between water intervention arm and control arm
- 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
- 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
- Hair cortisol concentration (pg/mg) [ Time Frame: 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.
- 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.
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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422848
Contact: Olle Melander, M.D., Prof | +46 40 391209 | olle.melander@med.lu.se | |
Contact: Sofia Enhörning, M.D., Ph.D. | +46 46 172210 | sofia.enhorning@med.lu.se |
Sweden | |
KFE, Skåne University Hospital in Malmö | Recruiting |
Malmö, Sweden, SE-20502 | |
Contact: Margaretha M Persson, Ph.D. margaretha.m.persson@skane.se | |
Contact: Olle Melander, M.D., Prof. +46 40 391209 olle.melander@med.lu.se | |
Principal Investigator: Olle Melander, M.D., Professor | |
Sub-Investigator: Sofia Enhörning, M.D., Ph.D. | |
Sub-Investigator: Irina Tasevska, M.D., Ph.D. |
Principal Investigator: | Olle Melander, M.D., Prof. | Lund University |
Documents provided by Olle Melander, Region Skane:
Responsible Party: | Olle Melander, Professor, Region Skane |
ClinicalTrials.gov Identifier: | NCT03422848 |
Other Study ID Numbers: |
2016894 |
First Posted: | February 6, 2018 Key Record Dates |
Last Update Posted: | November 18, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
hydration water vasopressin copeptin |
glucose OGTT insulin glucagon |