Characteristics of NAFLD Among Type 2 Diabetes Patients

The FibroScan® device measures vibration controlled transient elastography (VCTE) (kPa) Based on these values the liver stiffness status will be determined.

The FibroScan® device measures controlled attenuation parameter (CAP) (dB/m) Based on these values the liver steatosis status will be determined.

Out of the EPF (Electronic Patient file) the results of a possible earlier ultrasound are noted in the CRF. The results are noted as 'liver steatosis found' with yes/no answer and the year in which this ultrasound was performed.

Out of the EPF the results of a possible earlier ultrasound or liver biopsy are noted in the CRF. The results are noted as previous NAFLD diagnosis with yes/no answer and if confirmed by liver biopsy results. Next the NAS CRN (histological) score is noted.The score ranges from 0-8 and is composed of the unweighted sum of steatosis, ballooning, and lobular inflammation. A score between 0-2 corresponds to no NASH, 3-4 is borderline NASH, and definite NASH has a score between 5 and 8.

Out of the EPF the blood parameter AST (U/L) will be collected

Out of the EPF the blood parameter ALT (U/L) will be collected.

Out of the EPF the blood parameter GGT (U/L) will be collected.

Out of the EPF the blood parameter LDH (U/L) will be collected.

Out of the EPF the blood parameter total protein (g/L) will be collected.

Out of the EPF the blood parameter albumin (mg/dL) will be collected.

Out of the EPF the blood parameter ferritin (µg/L) will be collected.

Out of the EPF the blood parameter bilirubin total (mg/dL) will be collected.

hepatitis B, hepatitis C, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson disease and alpha 1 antitrypsin deficiency. NAFLD is a disease of exclusion and therefore the abovementioned parameters are determined out of the EPF.

The weight (kg)

The height (m)

The weight (kg) and height (m) will be determined and from this the BMI (kg/m²) will be calculated.

The waist circumference will be measured and noted in cm.

This questionnaire will be used to estimate the level of physical activity. It exists out of 16 questions about work, sports and leisure time. A higher score means that the person is more active at work, does more sport and has a more active leisure time. Minimum value is 3 and maximum value is 15.

General Anxiety Disorder (GAD-7) questionnaire will be used to determine the presence of possible clinically significant anxiety disorder.A higher scores indicates having anxiety. Minimum score is 0 and maximum score is 21.

Patient Health Questionnaire-9 (PHQ-9) will be used to quantify depression symptoms and monitor severity. . Minimum score is 0 and maximum score is 27. A higher score indicates having a depression.

Workers Productivity and Activity Impairment (WPAI-SHP) questionnaire. By means of 6 questions about work productivity and activity it can be determined if there is absence, productivity loss or a decrease in activities at work. By means of 6 questions about work productivity and activity it can be determined if there is absence, productivity loss or a decrease in activities at work. The score is expressed in percentages (0-100). A higher percentage indicates a higher absence from work and a lower productivity.

Short Form Health Survey-36 will be used to determine the health related quality of life based on 6 different topics: physical functioning, social functioning, role restrictions, mental wellbeing, energy and pain. The score is expressed in percentages (0-100). A higher percentage indicates a better general wellbeing.

The year of diagnosis is asked to the patient (yr).

The complications (retinopathy, nephropathy and neuropathy) of diabetes are asked to the patient and gathered out of the EPF. Answer will be yes/no to each of the complications.

The medication use will be noted in the CRF

serum creatine (mg/dL)

urine creatine (mg/dL)

micro-albumin (mg/dL)

albumin/creatine ratio (mg/g creat)

estimated glomerular filtration rate (ml/min/1,73m²).

Triglycerides (mg/dL) in blood

HDL (mg/dL) in blood

LDL cholesterol (mg/dL) in blood

Total cholesterol (mg/dL) in blood

thrombocytes (1000/µL) in blood

fasting glucose (mg/dL) in blood

partial alpha fetoprotein (AFP) in blood

haemoglobin A1c (%) in blood