Title
An Intervention Trial for Cardiac Neuropathy in Type 1 Diabetes
Oxidative Stress and Cardiovascular Denervation in Diabetes: An Interventional Trial
Phase
Phase 3Lead Sponsor
University of MichiganStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Diabetic Autonomic NeuropathyIntervention/Treatment
allopurinol nicotinamide ...Study Participants
44The 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.
Comparison of triple antioxidant combination therapy vs placebo.
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.
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
| Event Type | Organ System | Event Term | ORAL ANTIOXIDANT | Placebo |
|---|
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.
ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection
High Sensitivity CRP (nmol/L)
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.
