Type 2 diabetes patients have a high risk of developing NAFLD. This was confirmed during previous research, a high prevalence of NAFLD among type 2 diabetes mellitus patients was found. The investigators want to determine the characteristics of this population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
1,762
Type 2 diabetes patients have a high risk of developing NAFLD. This was confirmed during previous research, a high prevalence of NAFLD among type 2 diabetes mellitus patients was found. Now we want to determine the characteristics of this population.
Ziekenhuis Oost-Limburg
Genk, Belgium
VCTEM (KPa) measure
The FibroScan® device measures vibration controlled transient elastography (VCTE) (kPa) Based on these values the liver stiffness status will be determined.
Time frame: up to year four
CAPTM (dB/m) measure
The FibroScan® device measures controlled attenuation parameter (CAP) (dB/m) Based on these values the liver steatosis status will be determined.
Time frame: up to year four
Liver Ultrasound
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.
Time frame: up to year four
Liver biopsy
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.
Time frame: up to year four
Aspartate transaminase (AST)
Out of the EPF the blood parameter AST (U/L) will be collected
Time frame: up to year four
Alanine transaminase (ALT)
Out of the EPF the blood parameter ALT (U/L) will be collected.
Time frame: up to year four
Gamma glutamyltransferase (GGT)
Out of the EPF the blood parameter GGT (U/L) will be collected.
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Time frame: up to year four
Lactate dehydrogenase (LDH)
Out of the EPF the blood parameter LDH (U/L) will be collected.
Time frame: up to year four
total protein
Out of the EPF the blood parameter total protein (g/L) will be collected.
Time frame: up to year four
Albumin
Out of the EPF the blood parameter albumin (mg/dL) will be collected.
Time frame: up to year four
Ferritin
Out of the EPF the blood parameter ferritin (µg/L) will be collected.
Time frame: up to year four
bilirubin total
Out of the EPF the blood parameter bilirubin total (mg/dL) will be collected.
Time frame: up to year four
Exclusion of other liver diseases
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.
Time frame: up to year four
Weight
The weight (kg)
Time frame: up to year four
Height
The height (m)
Time frame: up to year four
BMI (Body Mass Index)
The weight (kg) and height (m) will be determined and from this the BMI (kg/m²) will be calculated.
Time frame: up to year four
waist circumference
The waist circumference will be measured and noted in cm.
Time frame: up to year four
Wellbeing - BAECKE
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.
Time frame: up to year four
Wellbeing - GAD-7
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.
Time frame: up to year four
Wellbeing - PHQ-9
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.
Time frame: up to year four
Wellbeing - WPAI-SHP
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.
Time frame: up to year four
Wellbeing - SF-36
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.
Time frame: up to year four
Diagnosis Diabetes
The year of diagnosis is asked to the patient (yr).
Time frame: up to year four
Diabetes complications
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.
Time frame: up to year four
concomitant medication
The medication use will be noted in the CRF
Time frame: up to year four
serum creatine
serum creatine (mg/dL)
Time frame: up to year four
urine creatine
urine creatine (mg/dL)
Time frame: up to year four
micro-albumin
micro-albumin (mg/dL)
Time frame: up to year four
albumin/creatine ratio
albumin/creatine ratio (mg/g creat)
Time frame: up to year four
estimated glomerular filtration rate
estimated glomerular filtration rate (ml/min/1,73m²).
Time frame: up to year four
Triglycerides (mg/dL)
Triglycerides (mg/dL) in blood
Time frame: up to year four
HDL (mg/dL)
HDL (mg/dL) in blood
Time frame: up to year four
LDL cholesterol (mg/dL)
LDL cholesterol (mg/dL) in blood
Time frame: up to year four
Total cholesterol (mg/dL).
Total cholesterol (mg/dL) in blood
Time frame: up to year four
thrombocytes
thrombocytes (1000/µL) in blood
Time frame: up to year four
fasting glucose (mg/dL)
fasting glucose (mg/dL) in blood
Time frame: up to year four
partial alpha fetoprotein (AFP)
partial alpha fetoprotein (AFP) in blood
Time frame: up to year four
haemoglobin A1c (%)
haemoglobin A1c (%) in blood
Time frame: up to year four