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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 : June 13, 2018
Sponsor:
Collaborators:
Lund University
Danone Research
Information provided by (Responsible Party):
Olle Melander, 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.

Condition or disease Intervention/treatment Phase
Glucose, High Blood Dietary Supplement: Water Behavioral: general life style advice Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 800 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 : March 31, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

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).
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).
Behavioral: general life style advice
oral and written advice on diet and physical activity




Primary Outcome Measures :
  1. Fasting plasma glucose concentration (mmol/L) [ Time Frame: 12 months ]
    Difference in change of fasting plasma glucose between water intervention arm and control arm.


Secondary Outcome Measures :
  1. Diabetes incidence [ Time Frame: 12 months ]
    Difference in diabetes incidence between water intervention arm and control arm.

  2. 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

  3. Fasting insulin concentration (mIE/L) [ Time Frame: 12 months ]
    Difference in change of fasting insulin (mIE/L) between water intervention arm and control arm

  4. 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

  5. Fasting glucagon concentration (pmol/L) [ Time Frame: 12 months ]
    Difference in change of fasting glucagon (pmol/L) between water intervention arm and control arm

  6. 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

  7. HbA1c concentration (mmol/mol) [ Time Frame: 12 months ]
    Difference in change of HbA1c (mmol/mol) between water intervention arm and control arm

  8. Waist circumference (cm) [ Time Frame: 12 months ]
    Difference in change of waist circumference (cm) between water intervention arm and control arm

  9. 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

  10. Systolic blood pressure (mmHg) [ Time Frame: 12 months ]
    Difference in change of systolic blood pressure (mmHg) between water intervention arm and control arm

  11. Diastolic blood pressure (mmHg) [ Time Frame: 12 months ]
    Difference in change of diastolic blood pressure (mmHg) between water intervention arm and control arm

  12. Triglyceride concentration (mmol/L) [ Time Frame: 12 months ]
    Difference in change of triglycerides (mmol/L) between water intervention arm and control arm

  13. HDL cholesterol concentration (mmol/L) [ Time Frame: 12 months ]
    Difference in change of HDL cholesterol (mmol/L) between water intervention arm and control arm

  14. LDL cholesterol concentration (mmol/L) [ Time Frame: 12 months ]
    Difference in change of LDL cholesterol (mmol/L) between water intervention arm and control arm

  15. Apolipoprotein B concentration (g/L) [ Time Frame: 12 months ]
    Difference in change of Apolipoprotein B (g/L) between water intervention arm and control arm

  16. Apolipoprotein A1 concentration (g/L) [ Time Frame: 12 months ]
    Difference in change of Apolipoprotein A1 (g/L) between water intervention arm and control arm

  17. 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

  18. 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

  19. Creatinine clearance (mL/min) [ Time Frame: 12 months ]
    Difference in change of creatinine clearance (mL/min) between water intervention arm and control arm

  20. Fasting cortisol concentration (nmol/L) [ Time Frame: 12 months ]
    Difference in change of fasting cortisol (nmol/L) between water intervention arm and control arm

  21. 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

  22. 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

  23. 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.


Other Outcome Measures:
  1. 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
Criteria

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).

Information from the National Library of Medicine

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


Contacts
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

Locations
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.         
Sponsors and Collaborators
Region Skane
Lund University
Danone Research
Investigators
Principal Investigator: Olle Melander, M.D., Prof. Lund University
  Study Documents (Full-Text)

Documents provided by Olle Melander, Region Skane:
Study Protocol  [PDF] December 15, 2017
Statistical Analysis Plan  [PDF] December 15, 2017


Responsible Party: Olle Melander, Professor, Region Skane
ClinicalTrials.gov Identifier: NCT03422848     History of Changes
Other Study ID Numbers: 2016894
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
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

Keywords provided by Olle Melander, Region Skane:
hydration
water
vasopressin
copeptin
glucose
OGTT
insulin
glucagon

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases