Background: A previous study has demonstrated that l-carnitine reduces plasma lipoprotein(a) (Lp[a]) levels in patients with hypercholesterolemia.
Objective: To test a tolerable Lp(a)-reducing agent in diabetic patients, we assessed the effect
of a dietary supplementation of l-carnitine on plasma lipid levels, particularly Lp(a), of patients with type 2 diabetes
mellitus (DM) and hypercholesterolemia.
Methods: In this 6-month, randomized, double-masked, placebo-controlled clinical trial, patients
were enrolled, assessed, and followed up at the Diabetic and Metabolic Diseases Center
of the Department of Internal Medicine and Therapeutics at the University of Pavia,
Pavia, Italy. All study patients had newly diagnosed type 2 DM that was managed through
dietary restriction alone throughout the study, as well as hypercholesterolemia. Patients
were randomized to 1 of 2 groups. One group received l-carnitine, one 1-g tablet BID. The other group received a corresponding placebo.
We assessed body mass index, fasting plasma glucose, postprandial plasma glucose,
glycosylated hemoglobin, fasting plasma insulin, total cholesterol, low-density lipoprotein
cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoprotein (apo)
A-I, apo B, and Lp(a) at baseline and at 1, 3, and 6 months of treatment.
Results: This study included 94 patients. The treatment group included 24 men and 22 women
(mean [SD] age, 52  years). The placebo group included 23 men and 25 women (mean
[SD] age, 50  years). The baseline characteristics of the groups did not differ
significantly. The mean (SD) body weight, height, and body mass index were 78.2 (5.8)
kg, 1.70 (0.04) m, and 27.3 (2.5) kg/m2, respectively, in the l-carnitine group and 77.6 (6.4) kg, 1.71 (0.05) m, and 26.8 (2.2) kg/m2, respectively, in the placebo group. In the treatment group, Lp(a) was significantly
reduced at 3 and 6 months compared with baseline (P < 0.05) and P < 0.01, respectively). We observed a significant improvement after 6 months (P < 0.05) in the Lp(a) value in patients taking l-carnitine compared with those taking placebo. Between-group differences in other
variables did not reach a level of significance at months 3 and 6. No drug-related
adverse events were reported or observed.
Conclusion: In this preliminary study, after 3 and 6 months, l-carnitine significantly lowered the plasma Lp(a) level compared with placebo in selected
hypercholesterolemic patients with newly diagnosed type 2 DM.