title: Improvement of Nonalcoholic Fatty Liver Disease With Carnitine-Orotate Complex in Type 2 Diabetes (CORONA): A Randomized Controlled Trial.
abstract: OBJECTIVE
  We aimed to evaluate the effects of carnitine-orotate complex in patients with nonalcoholic fatty liver disease (NAFLD) and diabetes.
  
  
  METHODS
  Eight hospitals in Korea participated in this randomized, controlled, double-blind trial of patients with diabetes and NAFLD. Seventy-eight patients were randomly assigned in a 1:1 ratio to receive carnitine-orotate complex (824 mg, three times daily) or matching placebo. The primary study outcome was decline in alanine aminotransferase (ALT) to the normal range. Secondary study outcomes were change in ALT, radiological hepatic steatosis, parameters for anthropometry, liver function, lipid profiles, and glycemic control. Hepatic steatosis was assessed using Hounsfield units on noncontrast computed tomography (CT) imaging with hepatic attenuation.
  
  
  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 HbA1c 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.
authors: Division of Endocrinology and Metabolism, Department of Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea.
authors: Ji Cheol
authors: JC
authors: Bae
authors: Division of Endocrinology and Metabolism, Department of Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors: Won Young
authors: WY
authors: Lee
authors: Division of Endocrinology and Metabolism, Department of Medicine, Seoul St. Mary's Hospital, The Catholic University School of Medicine, Seoul, Korea.
authors: Kun Ho
authors: KH
authors: Yoon
authors: Division of Endocrinology and Metabolism, Department of Medicine, Seoul Asan Hospital, University of Ulsan College of Medicine, Seoul, Korea.
authors: Joong Yeol
authors: JY
authors: Park
authors: Division of Endocrinology and Metabolism, Department of Medicine, Uijeongbu St. Mary's Hospital, The Catholic University School of Medicine, Seoul, Korea.
authors: Hyun Sik
authors: HS
authors: Son
authors: Department of Internal Medicine, Eulji General Hospital, Eulji University College of Medicine, Seoul, Korea.
authors: Kyung Ah
authors: KA
authors: Han
authors: Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
authors: Kwan Woo
authors: KW
authors: Lee
authors: Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea.
authors: Jeong Taek
authors: JT
authors: Woo
authors: Research and Development Department, Celltrion Pharm, Inc., Seoul, Korea.
authors: Young Cheol
authors: YC
authors: Ju
authors: Department of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors: Won Jae
authors: WJ
authors: Lee
authors: Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors: Yoon Young
authors: YY
authors: Cho
authors: Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea leemk@skku.edu.
authors: Moon-Kyu
authors: MK
authors: Lee
mesh_terms: D000410:Alanine Transaminase / Q000378:metabolism; D000886:Anthropometry; D001786:Blood Glucose / Q000378:metabolism; D002214:Capsules; D002331:Carnitine / Q000008:administration & dosage*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D065626:Non-alcoholic Fatty Liver Disease / Q000150:complications / Q000188:drug therapy*; D056910:Republic of Korea; D014057:Tomography, X-Ray Computed; D014815:Vitamins / Q000008:administration & dosage*
chemical_list: D000410:Alanine Transaminase; D001786:Blood Glucose; D002214:Capsules; D002331:Carnitine; D004338:Drug Combinations; D006442:Glycated Hemoglobin; D014815:Vitamins