Evaluation of Demographic Variances Amongst Randomized Non-alcoholic Fatty Liver Disease (NAFLD) Subjects in a Large Clinical Research Center

Introduction: NAFLD is a disease state which has grown into a silent pandemic and presents a challenge in patient identification. Non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH) are subtypes of NAFLD with the latter subtype presenting inflammation and fibrosis. To elucidate the demographics of NAFLD patients, a multivariate analysis on a cohort of confirmed NAFLD patients randomized into phase 2 and 3 clinical trials were assessed. The aim of this project is to identify a more accurate screening criteria to target the at-risk population for NAFLD and to prevent progression of NAFLD. Methods: A retrospective medical record analysis was completed including 143 randomized subjects within NAFLD studies, that received liver biopsy confirmation. Data includes the following: gender, age, ethnicity, hip-waist circumference, BMI, potential NAFLD related morbidities including metabolic risk factors, and various lab values. Results: The results show that majority of patients randomized into NAFLD and NASH studies are over the age of 50, non-Hispanic, and primarily white. This is likely due to the urban population demographics which greatly mirrors these results. Male and female randomization rates are almost equal in value (see graph 1). Conclusion: The above data will benefit the NASH research disease state by identifying subjects that increase enrollment criteria