Biomarkers of Steatohepatitis in Type 2 Diabetes Patients

Prior treatment

• Concurrent acute inflammatory disease.
• 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:

Other illness

• Failure to meet the study-specific alcohol-related eligibility criteria described below.
• History of other liver disease.
• Unstable or decompensated chronic disorders, including heart failure, respiratory failure, kidney failure, or thyroid gland disorders.

Other

• 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.

• 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.