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Completed

NCT Number: NCT00116207

An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes

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.

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Key information

Conditions

Diabetic Autonomic Neuropathy Autoimmune Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Neuropathies Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORAL ANTIOXIDANT

Drug

Comparison of triple antioxidant combination therapy vs placebo.

Other names: Allopurinol (300mg daily),, ALA (600mg twice daily), nicotinamide (750 mg twice daily)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Systemic Oxidative Stress

    Time frame: 24 months

    ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection

  3. Inflammation

    Time frame: 24 months

    High Sensitivity CRP (nmol/L)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Juvenile Diabetes Research Foundation

Registry information

Official study title

Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial

Important dates

Study start
2000
Primary completion
2009
Study completion
2009
First posted
Jun 28, 2005
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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