The Effect of Thiazide, Amiloride and Hypertonic Saline on Urinary Biomarkers in Healthy Subjects
THAM
Effect of Thiazide, Amiloride and Hypertonic Saline on Sodium- and Water Channel Activity in the Nephron in Healthy Subjects Estimated by Urinary Biomarkers
1 other identifier
interventional
24
1 country
1
Brief Summary
Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) reflects the activity of the sodium- and water channels in the human kidney. Changes in the sodium-and water channel activity can be induced by blocking the sodium channels with diuretics in healthy subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedFirst Posted
Study publicly available on registry
July 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMarch 4, 2014
March 1, 2014
1.2 years
June 13, 2012
March 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
urinary biomarkers
Urinary excretion of epithelial sodium channels (ENaC), Sodium-potassium-2chloride transporters (NKCC2) and aquaporin2 channels (AQP2) before, during and after fluid infusion
baseline, 0 hours and 1.5 hours after intervention
Secondary Outcomes (3)
vaso active hormones
baseline, 0 hours and 1.5 hours after intervention
central blood pressure
baseline, 0 hours and 1.5 hours after intervention
intracellular (ICV)- and extracellular volume (ECV)
baseline, 0 hours and 1.5 hours after intervention
Study Arms (3)
thiazide, diuretic
ACTIVE COMPARATOR1.25 mg thiazide twice daily for 5 days
amiloride, diuretic
ACTIVE COMPARATOR5 mg of amiloride twice daily
calcium
PLACEBO COMPARATORplacebo twice daily for 5 days
Interventions
hypertonic saline 3.0% 7 ml/kg
Eligibility Criteria
You may qualify if:
- healthy males and females
- age 18-45
- BMI range 18,5-30,0 kg/m2
You may not qualify if:
- hypertension (i.e. ambulatory BP \> 130 mmHg systolic or/and \> 80 mmHg diastolic)
- history or clinical significant signs of heart, lung, liver, kidney, endocrine, brain or neoplastic
- disease.
- alcohol abuse
- drug abuse
- smoking
- pregnancy or nursing
- blood donation within a month prior to examination
- medical treatment apart from oral contraception abnormal blood samples, -ECG and -urine dipstick, drug abuse, alcohol abuse, pregnancy, medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Research
Holstebro, 7500, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Erling B Pedersen, MD, DMSc
Medical Research, Holstebro
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.d student Janni Majgaard Jensen
Study Record Dates
First Submitted
June 13, 2012
First Posted
July 9, 2012
Study Start
July 1, 2012
Primary Completion
September 1, 2013
Study Completion
November 1, 2013
Last Updated
March 4, 2014
Record last verified: 2014-03