Lobeglitazone, a Novel Thiazolidinedione, Improves Non-Alcoholic Fatty Liver Disease in Type 2 Diabetes: Its Efficacy and Predictive Factors Related to Responsiveness

Lee, Yong-ho; Kim, Jae Hyeon; Kim, So Ra; Jin, Heung Yong; Rhee, Eun-Jung; Cho, Young Min; Lee, Byung-Wan

Participants were considered eligible for the study if they had been diagnosed with T2D and were ≥ 20 years old. Participants also had to be drug-free (or naïve for more than three months) with HbA1C values between 7.0% and 8.5% (53.0 and 69.4 mM/ M) or taking a stable dose of metformin with HbA1C values between 7.0% and 9.0% (53.0 and 74.9 mM/M) at the time of screening. Subjects were excluded if they consumed > 210 g/week of alcohol for males and 140 g/week for females or were positive for hepatitis B or C, type 1 diabetes, or secondary diabetes. Subjects with a history of renal dysfunction (serum creatinine ≥ 1.5 mg/dL for males and 1.4 mg/dL for females), heart failure (New York Heart Association [NYHA] class III and IV), uncontrolled heart arrhythmia, or cardio-cerebral events (unstable angina, myocardial infarction, transient ischemic attack, cerebral infarct, or hemorrhage) within the 12-week period prior to screening were excluded. Subjects with a history of corticosteroid treatment for at least 14 days within the two-month period prior to screening or those with cancer treatment, including chemo-or radiotherapy within two years, were also excluded. Pregnant women and nursing mothers were excluded. Of the remaining T2D subjects, those with NAFLD, as confirmed by a CAP value ≥ 250 dB/m, were enrolled in this study. , and TG), and high-sensitivity C-reactive protein (hsCRP). In addition, alterations from baseline in the homeostasis model assessment of insulin resistance (HOMAIR), which was quantified based on FPG and fasting insulin levels, were used as secondary endpoints. During the study period, patients visited the clinic for initial screening and baseline measurement, in addition to weeks 12 and 24. During both the initial screening and at 12-and 24-week visits, fasting blood samples for all subjects, as well as urine pregnancy tests for female participants of childbearing age, were taken for laboratory assessment. At the baseline visit, CAP and liver US were performed. At the 24-week visit, CAP was performed again. Before entering the study, we assessed the daily dietary and exercise routines of all participants, and then, they were educated and asked to maintain a calorie limited-diet while performing more than 150 min/week of medium-intensity aerobic exercise.