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NCT02236520 · ClinicalTrials.gov registry record · Phase 2
Tissue Sodium in Pre-hypertensive Patients
A Phase 2 study, sponsored by Vanderbilt University.
- Completed
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
NCT02236520 is a Phase 2 study that has completed, run by Vanderbilt University. The registered enrollment target is 71 participants.
The verdict
NCT02236520, a Phase 2 study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
Study Summary
Cardiovascular disease is the first common cause of death worldwide. Hypertension is the number one driving risk factor. Hypertension has long been associated with dietary salt intake. We believe that the accumulation of salt in the interstitium and inside cells represents a neglected risk factor, which initiates a pro-inflammatory state, chronically increases blood pressure, and leads to systemic energy imbalance. We will explore the concept that Na+ storage in the skin and in muscle is associated with increased blood pressure, a pro-inflammatory state, and reduced insulin sensitivity. We will do so by addressing the following specific aims: * Specific Aim 1: To test the hypothesis that African Americans are characterized by increased tissue Na+ storage, which is paralleled by higher blood pressure, reduced forearm blood flow, and enhanced pulse wave velocity * Specific Aim 2: To test the hypothesis that treatment with spironolactone reduces tissue Na+ content * Specific Aim 3: To test the hypothesis that Na+ storage leads to immune cell activation * Specific Aim 4: To test the hypothesis that the accumulation of salt in skin and muscle is associated with decreased insulin sensitivity and propensity to diabetes mellitus
Interventions
- DRUG Placebo
- DRUG Spironolactone
- DRUG Chlorthalidone
- DIETARY_SUPPLEMENT Diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2014-09 |
| Est. Completion | 2018-05-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02236520
The ClinicalTrials.gov registry entry for NCT02236520 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02236520 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02236520 about?
NCT02236520 is a clinical study titled "Tissue Sodium in Pre-hypertensive Patients". Cardiovascular disease is the first common cause of death worldwide. Hypertension is the number one driving risk factor. Hypertension has long been associated with dietary salt intake. We believe that the accumulation of salt in the interstitium and inside cells represents a neglected risk factor, w...
What is the current status of trial NCT02236520?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2014-09. Estimated completion is 2018-05-01.
What interventions are being tested in trial NCT02236520?
The interventions under investigation include: Placebo (DRUG), Spironolactone (DRUG), Chlorthalidone (DRUG), Diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02236520?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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