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).


METHODS
Randomised, double-blind, clinical trial, conducted in the Unit of Medical Angiology of the University of Catania.


METHODS
Seventy-four patients with NIDDM-associated PAD were treated with PLC (2 g/day) or placebo for 12 months.


METHODS
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.
Santo
Signorelli Salvatore
SS
Department of Internal Medicine and Systemic Pathology, Medical Angiology Section, Italy. ssignore@unict.it
Sergio
Neri
N
Luigi
Di Pino
DP
Giuseppe
Marchese
M
Margherita
Ferrante
F
Gea
Oliveri Conti
OC
Roberto
Fallico
F
Gabriella
Celotta
C
Giuseppe
Pennisi
P
Massimiliano
Anzaldi
A
D000368:Aged; D000447:Aldehydes / Q000097:blood; D000842:Ankle / Q000098:blood supply; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure / Q000187:drug effects; D001916:Brachial Artery / Q000502:physiology; D002331:Carnitine / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D008078:Cholesterol, LDL / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D003925:Diabetic Angiopathies / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D004311:Double-Blind Method; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D008315:Malondialdehyde / Q000097:blood; D008875:Middle Aged; D010084:Oxidation-Reduction / Q000187:drug effects; D010147:Pain Measurement / Q000706:statistics & numerical data; D010919:Placebos / Q000008:administration & dosage
D000447:Aldehydes; D001786:Blood Glucose; D002331:Carnitine; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin; D008315:Malondialdehyde; D010919:Placebos; C003223:propionylcarnitine; C027576:4-hydroxy-2-nonenal