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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Comparison of triple antioxidant combination therapy vs placebo.
University of Michigan
Ann Arbor, Michigan, United States
Global [11C]HED Retention Index (RI)
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.
Time frame: Baseline, 24 months
Global Coronary Flow Reserve as a Measure of Endothelial Function
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.
Time frame: Baseline, 24 months
Systemic Oxidative Stress
ng of 8-epi prostaglandin F2alpha /G creatinine assessed in 24 hour urine collection
Time frame: 24 months
Inflammation
High Sensitivity CRP (nmol/L)
Time frame: 24 months
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