An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

June 30, 2016 updated by: Rodica Pop-Busui, University of Michigan

Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes
  • A1C <9%
  • Mild neuropathy
  • Mild retinopathy
  • Mild nephropathy

Exclusion Criteria:

  • History of drug or alcohol dependence, heart disease, viral illness, liver disease, advanced kidney disease
  • Pregnant or nursing
  • Severely overweight

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ORAL ANTIOXIDANT
Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally These drugs were given together as a combination and not as individual treatment.
Drug: ORAL ANTIOXIDANT
Comparison of triple antioxidant combination therapy vs placebo.
Other Names:
  • Allopurinol (300mg daily),
  • ALA (600mg twice daily)
  • nicotinamide (750 mg twice daily)
Placebo Comparator: Placebo
Placebo administered twice daily.
Drug: ORAL ANTIOXIDANT
Comparison of triple antioxidant combination therapy vs placebo.
Other Names:
  • Allopurinol (300mg daily),
  • ALA (600mg twice daily)
  • nicotinamide (750 mg twice daily)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global [11C]HED Retention Index (RI)
Time Frame: Baseline, 24 months

Distal defects in [11C]meta-hydroxyephedrine ([11C]HED) retention involving at least 10 % of the left ventricle was used to define Cardiac Autonomic Neuropathy (CAN). The retention index (RI) is the unit of measure and is expressed as [11C]HEDblood min -1[ml tissue]-1

PET Data of Randomized Subjects at Baseline and 24-Months

The primary outcome was the change in the global [11C]HED RI = measure of cardiac innervation at 24 months in participants taking the active drug compared with those on placebo.
Baseline, 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Coronary Flow Reserve as a Measure of Endothelial Function
Time Frame: Baseline, 24 months
global myocardial blood flow reserve as a measure of endothelial function. Measured by PET using [13N]ammonia at rest and during adenosine stimulated coronary vasodilation.
Baseline, 24 months
Systemic Oxidative Stress
Time Frame: 24 months
ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection
24 months
Inflammation
Time Frame: 24 months
High Sensitivity CRP (nmol/L)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Juvenile Diabetes Research Foundation

Investigators

  • Principal Investigator: Eva L Feldman, MD, PhD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 27, 2005

First Submitted That Met QC Criteria

June 27, 2005

First Posted (Estimate)

June 28, 2005

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB:2002-0460

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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