CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 44 enrolled
Drug / intervention
ORAL ANTIOXIDANTdrug
Likely dose
Oral antioxidant combination therapy (dose not specified)AI-extracted
Key inclusion· 5
  • ✓Type 1 diabetes mellitus
  • ✓Hemoglobin A1C less than 9%
  • ✓Mild diabetic neuropathy
  • ✓Mild diabetic retinopathy
Key exclusion· 6
  • ✕History of drug or alcohol dependence
  • ✕History of heart disease
  • ✕History of liver disease
  • ✕Advanced kidney disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00116207
NCT00116207Phase 3Completed
CompareCT.gov

Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial

University of Michigan·interventional·Posted Jun 28, 2005·Updated Jul 29, 2016

In Brief

A Phase 3 clinical trial evaluating ORAL ANTIOXIDANT for Diabetic Autonomic Neuropathy. Completed, enrolled 44 participants across 1 site.

Detailed Summary

The focus of this project is cardiovascular diabetic autonomic neuropathy (DAN). DAN affects the nerves that control heart rate and blood flow to the heart in people with diabetes. DAN may cause problems with the rhythm of the heartbeat or decrease blood flow to the heart. Three medications will be tested for their effectiveness in DAN.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Autonomic Neuropathy
CountriesUnited States
CollaboratorsJuvenile Diabetes Research Foundation

Timeline

Phase 3CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 28, 2005
Enrollment StartJan 1, 2000
Primary CompletionSep 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9.7 yearsPosted 21.0 years ago

Interventions

ORAL ANTIOXIDANTdrug

Comparison of triple antioxidant combination therapy vs placebo.