Effect of alpha lipoic acid on cardiac autonomic dysfunction and platelet reactivity in type 1 diabetes: rationale and design of the AUTOnomic function and platelet REACTivity trial (AUTO-REACT protocol).

摘要

BACKGROUND: The aim of this study is to assess the relationship between cardiac autonomic dysfunction and increased platelet reactivity in patients with type 1 diabetes and whether alpha lipoic acid therapy (ALA) might improve both abnormalities in these patients. METHODS AND MATERIALS: Cardiac autonomic function will be assessed by heart rate variability (HRV) analysis. Platelet reactivity will be investigated by both measuring the aggregation time on the PFA-100 method and flow cytometry. HRV and platelet reactivity will be re-assessed in the patients with depressed HRV after 4 weeks from randomization to ALA or placebo. DISCUSSION: The cardiovascular autonomic system might play a role in the modulation of platelet reactivity which is increased in diabetes. Within this framework, ALA might be found to exercise antithrombotic effects in addition to its known antioxidants properties. TRIAL REGISTRATION: Australian Clinical Trials Registry ACTRN 12610000291088.