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NCT02034435 · ClinicalTrials.gov registry record · Phase 4

Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism

A Phase 4 study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
Phase 4
Development phase
44
Enrollment target

NCT02034435: Completed Phase 4 study, sponsored by Vanderbilt University Medical Center.

NCT02034435 is a Phase 4 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 44 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02034435, a Phase 4 study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
44 participants
Enrollment target

Study 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.

Primary Outcome

Hyperglycemic clamp- acute insulin response (AIR) during time 0-10 minutes

Interventions

  • DRUG Amlodipine
  • OTHER Low Salt diet plus Placebo tablet
  • OTHER Low Sodium diet plus Salt tablet
  • DRUG Epleronone

Trial Details

FieldValue
Enrollment Target 44 participants
Start Date 2013-10
Est. Completion 2019-12
Phase Phase 4

What the finished NCT02034435 record still lists

NCT02034435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 4 interventions - of which Amlodipine is the first listed.

NCT02034435 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02034435 about?

NCT02034435 is a clinical study titled "Endogenous Renin-Angiotensin-Aldosterone System and Glucose Metabolism". 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 secre...

What is the current status of trial NCT02034435?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2013-10. Estimated completion is 2019-12.

What interventions are being tested in trial NCT02034435?

The interventions under investigation include: Amlodipine (DRUG), Low Salt diet plus Placebo tablet (OTHER), Low Sodium diet plus Salt tablet (OTHER), Epleronone (DRUG).

Who is sponsoring clinical trial NCT02034435?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02034435's enrollment target sits among peer trials

44 1363rd of 2000 higher than 630 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02034435, the US trial registry maintained by the National Library of Medicine. NCT02034435 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.