Effect of PLC on functional parameters and oxidative profile in type 2 diabetes-associated PAD

Objective: To investigate the effects of propionyl L-carnitine (PLC) on clinical and functional parameters, and markers of the overall oxidation state in patients with peripheral arterial disease (PAD) associated with non-insulin-dependent diabetes mellitus (NIDDM). Design and setting: Randomised, double-blind, clinical trial, conducted in the Unit of Medical Angiology of the University of Catania. Patients and interventions: Seventy-four patients with NIDDM-associated PAD were treated with PLC (2 g/day) or placebo for 12 months. Main outcome measures: Ankle/brachial index (ABI) and the distance of pain-free walking were evaluated at baseline, 6 and 12 months. Malondialdehyde, 4-hydroxynonenal, oxidation time of low-density lipoproteins, and nitrite/nitrate ratio were measured as indices of the overall oxidation profiles at baseline and 12 months. Results: In the PLC group, ABI progressively increased (0.78, 0.83, and 0.88 at 0, 6 and 12 months, respectively). The distance of pain-free walking also improved (366.4, 441.9 and 519.8 m, respectively). In the placebo group, these parameters were relatively unchanged. Significant improvements in all parameters of the oxidative profile were seen in the PLC-treated group, with only minor variations observed in the placebo group. Conclusions: These results suggest that adjunct therapy with PLC may be warranted in type 2 diabetes-associated PAD. (c) 2005 Elsevier Ireland Ltd. All rights reserved.