Improvement of Non-Alcoholic Fatty Liver Disease with Carnitine Orotate Complex in Type 2 Diabetes (CORONA): A Randomized Controlled Trial

Authors and Disclosures

Ji Cheol Bae, Won Young Lee, Kun Ho Yoon, Joon Yeol Park, Hyun Sik Son, Kyung Ah Han, Kwan Woo Lee, Jeong Taek Woo, Young Cheol Ju, Won Jae Lee, Yoon Young Cho, and Moon-Kyu Lee
Received December 1, 2014 and accepted March 25, 2015
Corresponding Author: Moon-Kyu Lee, leemk@skku.edu
J.C.B and W.Y.L contributed equally to this work as first author

ABSTRACT


OBJECTIVE

We aimed to evaluate the effects of carnitine-orotate complex in patients with nonalcoholic fatty liver disease (NAFLD) and diabetes.


RESEARCH DESIGN AND METHODS

In patients with NASH and control subjects, we randomly dispensed one 1-g L-carnitine tablet after breakfast plus diet and one 1 g tablet after dinner plus diet for 24 weeks or diet alone at the same dosage and regimen. We evaluated liver enzymes, lipid profile, fasting plasma glucose, C-reactive protein (CRP), tumor necrosis factor (TNF)-α, homeostasis model assessment (HOMA)-IR, body mass index, and histological scores.


RESULTS

After 12 weeks of treatment, compared with placebo group, carnitine-orotate complex-treated participants had a significantly higher rate of normalization of serum ALT level (17.9% vs. 89.7%, P < 0.001). On hepatic CT analysis, participants treated with carnitine-orotate complex showed an increased liver attenuation index (0.74 + 8.05 vs. 6.21 + 8.96, P < 0.008). A significant decrease in HbA;,. was observed in the carnitine-orotate complex group (—0.33 + 0.82% [—3.6 + 9.0 mmol/mol], P = 0.007), but no significant change was seen in the placebo group.


CONCLUSIONS

Treatment with carnitine-orotate complex improves serum ALT and may improve hepatic steatosis as assessed by CT in patients with diabetes and NAFLD. Further studies using more advanced magnetic resonance imaging and liver histology as an end point are needed to assess its efficacy in NAFLD.

Ectopic fat accumulation in a visceral organ is associated with insulin resistance (1). As an example of such ectopic fat accumulation, nonalcoholic fatty liver disease (NAFLD) is now recognized as the hepatic component of metabolic syndrome and is even reportedly associated with insulin resistance independent of obesity and other metabolic components. Therefore, NAFLD can be a major determinant of insulin.