At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 44 enrolled
Drug / intervention
Epleronone +3 moredrug
Likely dose
Epleronone 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism
In Brief
A Phase 4 clinical trial evaluating Low Salt diet plus Placebo tablet, Low Sodium diet plus Salt tablet, and 2 other interventions for Metabolic Syndrome. Completed, enrolled 44 participants across 1 site.
Detailed Summary
Aim 1.Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs glycemic control via effects on insulin sensitivity and insulin secretion. Aim 2. Test the hypothesis that activation of the endogenous renin-angiotensin-aldosterone system impairs insulin secretion and insulin sensitivity via an mineralocorticoid-receptor dependent mechanism.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolic Syndrome
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartOct 2013
First PostedJan 2014
Primary CompletionDec 2019
TodayJul 2026
First PostedJan 13, 2014
Enrollment StartOct 1, 2013
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 12.5 years ago
Interventions
Low Salt diet plus Placebo tabletother
Low Sodium diet plus Salt tabletother
Eplerononedrug
50mg daily
Amlodipinedrug
5mg daily