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NCT02682901 · ClinicalTrials.gov registry record · Phase 4

Bromocriptine-QR Therapy on Sympathetic Tone and Vascular Biology in Type 2 Diabetes Subjects

A Phase 4 study, sponsored by Eastern Virginia Medical School.

Completed
Registry status
Phase 4
Development phase
84
Enrollment target

NCT02682901: Completed Phase 4 study, sponsored by Eastern Virginia Medical School.

NCT02682901 is a Phase 4 study that has completed, run by Eastern Virginia Medical School. The registered enrollment target is 84 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02682901, a Phase 4 study, has completed, sponsored by Eastern Virginia Medical School.

COMPLETED
Registry status
Phase 4
Development phase
84 participants
Enrollment target

Study Summary

The main objective is to demonstrate the effects of early dopaminergic activation on the autonomic nervous system in subjects with newly diagnosed vs. established type 2 diabetes. The primary endpoint is the effect of Bromocriptine QR on changes in autonomic function measured by assessing sympathetic and parasympathetic function using conventional measures of autonomic function, including power spectral analysis of heart rate as well as peripheral autonomic function using sudorimetry and laser scanning of peripheral microvascular autonomic control.

Primary Outcome

Cardiac Autonomic Reflex Tests (CARTs) based on heart rate variations are the deep breathing test (E/I ratio), the lying to standing test (30:15 ratio) and the Valsalva maneuver (Valsalva ratio). These tests require a continuous recording of heart rate by either a simple electrocardiograph (ECG), subsequently elaborated via a specialist software. It is essential to inspect the ECG trace (on paper or monitor) in order to exclude artifacts or any type of arrhythmias from the calculations. Expirat

Interventions

  • DRUG Placebo
  • DRUG Cycloset

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2015-10-05
Est. Completion 2018-11-15
Phase Phase 4
Eastern Virginia Medical School

36 total trials

What the finished NCT02682901 record still lists

NCT02682901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02682901 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02682901 about?

NCT02682901 is a clinical study titled "Bromocriptine-QR Therapy on Sympathetic Tone and Vascular Biology in Type 2 Diabetes Subjects". The main objective is to demonstrate the effects of early dopaminergic activation on the autonomic nervous system in subjects with newly diagnosed vs. established type 2 diabetes. The primary endpoint is the effect of Bromocriptine QR on changes in autonomic function measured by assessing sympatheti...

What is the current status of trial NCT02682901?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 84 participants. The study started on 2015-10-05. Estimated completion is 2018-11-15.

What interventions are being tested in trial NCT02682901?

The interventions under investigation include: Placebo (DRUG), Cycloset (DRUG).

Who is sponsoring clinical trial NCT02682901?

This trial is sponsored by Eastern Virginia Medical School, which has 36 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02682901's enrollment target sits among peer trials

84 929th of 2000 higher than 1,064 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 NCT02682901, the US trial registry maintained by the National Library of Medicine. NCT02682901 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.