Biomarkers of Steatohepatitis in Type 2 Diabetes Patients

The aims of the study are to identify a subgroup of type 2 diabetics at risk of developing and progressing to non-alcoholic steatohepatitis (NASH), to correlate clinical and laboratory parameters with sonographic and elastographic findings in order to pinpoint indicators of liver fibrosis (NASH), and to facilitate targeted screening and intensified management of type 2 diabetes mellitus to prevent NASH complications.

Inclusion Criteria: * Age 18 to 75 years, inclusive. * Diagnosis of type 2 diabetes mellitus, irrespective of glucose-lowering treatment. * Suspected liver involvement, defined by at least one of the following: * Ultrasonographically detected hepatic steatosis; * Hepatomegaly; or * Elevation of liver enzymes above the applicable laboratory upper limit of normal. * Written informed consent. Exclusion Criteria: * Failure to meet the study-specific alcohol-related eligibility criteria described below. * History of other liver disease. * Concurrent acute inflammatory disease. * Unstable or decompensated chronic disorders, including heart failure, respiratory failure, kidney failure, or thyroid gland disorders. * Concurrent oncological diagnosis or treatment. Alcohol-related eligibility criteria: Alcohol consumption was assessed at recruitment using a structured verbal interview. Questions 1-3 were based on AUDIT-C and covered the preceding 12 months. Question 4 addressed lifetime history. All of the following response requirements had to be met: * Question 1: "How often did you have a drink containing alcohol in the past year?" Eligible responses were "never" (0 points), "monthly or less" (1 point), or "2-4 times a month" (2 points). * Question 2: "How many drinks containing alcohol did you have on a typical day when you were drinking in the past year?" Among participants who drank alcohol, only 1-2 drinks (0 points) was accepted. Usual quantity was not applicable to abstainers. * Question 3: "How often did you have six or more drinks on one occasion in the past year?" Only "never" (0 points) was accepted. * Question 4: "Was there ever a period in your life when you drank more than indicated by your responses to questions 1-3?" Only "no, never" was accepted. The lifetime-history question was assessed separately and was not added to the AUDIT-C total. Eligibility depended on the specified item-level responses, not merely on a total AUDIT-C score of 0-2. The same criteria applied to women and men. One local serving was defined as 500 mL of beer, 200 mL of wine, or 50 mL of spirits. These volumes were not assumed to contain identical amounts of ethanol.