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.