Background: Oxidative stress has been implicated in the pathophysiology of diabetic complications. Alpha-lipoic acid (LA), a potent antioxidant, has been shown to be an effective treatment for diabetic neuropathy when given intravenously. Recently, an oral controlled-release formulation of alpha-lipoic acid (CRLA) was developed, and a pharmacokinetic study demonstrated that CRLA maintained significant plasma levels for 67% longer than a common quick-release formulation.
Objective: To determine if CRLA is an effective antioxidant in type 1 diabetes mellitus (T1D) by measuring its effects on markers of oxidative damage and total antioxidant status.
Methods: Forty pubertal and postpubertal adolescents with T1D underwent a double-blind, randomized, placebo-controlled study of CRLA for 3 months. 8-hydroxy-2'-deoxyguanosine, 2-thiobarbituric acid-reactive substances, protein carbonyl, total reactive antioxidant potential, hemoglobin A1c (HbA1c), and spot random urine collected for albumin to creatinine ratio were measured before and after treatment.
Results: There was no significant change in any measurement of oxidative damage, total antioxidant status, HbA1c, or microalbuminuria prevalence after treatment with either placebo or CRLA.
Conclusion: In this pilot study, CRLA was not an effective treatment for decreasing oxidative damage in T1D, although efficacy may have been limited by issues with compliance.