CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 84 enrolled
Drug / intervention
Cycloset +1 moredrug
Likely dose
Cycloset 3.2 mgfrom 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.

Search/NCT02682901
NCT02682901Phase 4Completed
CompareCT.gov

Impact of Timed Bromocriptine-QR Therapy Upon Measures of Sympathetic Tone and Vascular Biology in Type 2 Diabetes Subjects

Eastern Virginia Medical School·interventional·Posted Feb 17, 2016·Updated Dec 10, 2021

In Brief

A Phase 4 clinical trial evaluating Cycloset and Placebo for Diabetic Autonomic Neuropathy. Completed, enrolled 84 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Autonomic Neuropathy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 17, 2016
Enrollment StartOct 5, 2015
Primary CompletionNov 15, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 10.4 years ago

Interventions

Cyclosetdrug

Cycloset 1.6 -3.2 mg/day

Placebodrug

Non-active placebo for cycloset