Non-Alcoholic Fatty Liver Disease, Type2 Diabetes
Conditions
Keywords
NAFLD, NAFLD, characteristics, type 2 diabetes, hospital
Brief summary
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.
Interventions
OTHERScreening and studying characteristics
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.
Sponsors
Ziekenhuis Oost-Limburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18-80 years, * having type 2 diabetes, * able to understand Dutch, * able to understand the informed consent
Exclusion criteria
* excessive alcohol abuse, * other liver disease, * secondary causes of steatosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wellbeing - WPAI-SHP | up to year four | 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. |
| Diagnosis Diabetes | up to year four | The year of diagnosis is asked to the patient (yr). |
| VCTEM (KPa) measure | up to year four | The FibroScan® device measures vibration controlled transient elastography (VCTE) (kPa) Based on these values the liver stiffness status will be determined. |
| CAPTM (dB/m) measure | up to year four | The FibroScan® device measures controlled attenuation parameter (CAP) (dB/m) Based on these values the liver steatosis status will be determined. |
| Liver Ultrasound | up to year four | 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. |
| Liver biopsy | up to year four | 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. |
| Aspartate transaminase (AST) | up to year four | Out of the EPF the blood parameter AST (U/L) will be collected |
| Alanine transaminase (ALT) | up to year four | Out of the EPF the blood parameter ALT (U/L) will be collected. |
| Gamma glutamyltransferase (GGT) | up to year four | Out of the EPF the blood parameter GGT (U/L) will be collected. |
| Lactate dehydrogenase (LDH) | up to year four | Out of the EPF the blood parameter LDH (U/L) will be collected. |
| total protein | up to year four | Out of the EPF the blood parameter total protein (g/L) will be collected. |
| Albumin | up to year four | Out of the EPF the blood parameter albumin (mg/dL) will be collected. |
| Ferritin | up to year four | Out of the EPF the blood parameter ferritin (µg/L) will be collected. |
| bilirubin total | up to year four | Out of the EPF the blood parameter bilirubin total (mg/dL) will be collected. |
| Exclusion of other liver diseases | up to year four | 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. |
| Weight | up to year four | The weight (kg) |
| Height | up to year four | The height (m) |
| BMI (Body Mass Index) | up to year four | The weight (kg) and height (m) will be determined and from this the BMI (kg/m²) will be calculated. |
| waist circumference | up to year four | The waist circumference will be measured and noted in cm. |
| Wellbeing - BAECKE | up to year four | 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. |
| Diabetes complications | up to year four | 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. |
| Wellbeing - GAD-7 | up to year four | 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. |
| Wellbeing - PHQ-9 | up to year four | 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. |
| Wellbeing - SF-36 | up to year four | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| micro-albumin | up to year four | micro-albumin (mg/dL) |
| haemoglobin A1c (%) | up to year four | haemoglobin A1c (%) in blood |
| albumin/creatine ratio | up to year four | albumin/creatine ratio (mg/g creat) |
| estimated glomerular filtration rate | up to year four | estimated glomerular filtration rate (ml/min/1,73m²). |
| Triglycerides (mg/dL) | up to year four | Triglycerides (mg/dL) in blood |
| HDL (mg/dL) | up to year four | HDL (mg/dL) in blood |
| LDL cholesterol (mg/dL) | up to year four | LDL cholesterol (mg/dL) in blood |
| Total cholesterol (mg/dL). | up to year four | Total cholesterol (mg/dL) in blood |
| thrombocytes | up to year four | thrombocytes (1000/µL) in blood |
| fasting glucose (mg/dL) | up to year four | fasting glucose (mg/dL) in blood |
| partial alpha fetoprotein (AFP) | up to year four | partial alpha fetoprotein (AFP) in blood |
| concomitant medication | up to year four | The medication use will be noted in the CRF |
| serum creatine | up to year four | serum creatine (mg/dL) |
| urine creatine | up to year four | urine creatine (mg/dL) |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORGeert Robaeys, prof. dr.
Hasselt University
STUDY_CHAIRLeen Heyens, drs.
Hasselt University
Outcome results
None listed