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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 Diabetes Mellitus patients | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening and studying characteristics | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| VCTEM (KPa) measure | The FibroScan® device measures vibration controlled transient elastography (VCTE) (kPa) Based on these values the liver stiffness status will be determined. | 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. | 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. | 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. | up to year four |
| Aspartate transaminase (AST) | Out of the EPF the blood parameter AST (U/L) will be collected | up to year four |
| Alanine transaminase (ALT) | Out of the EPF the blood parameter ALT (U/L) will be collected. | up to year four |
| Measure | Description | Time Frame |
|---|---|---|
| concomitant medication | The medication use will be noted in the CRF | up to year four |
| serum creatine | serum creatine (mg/dL) | up to year four |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geert Robaeys, prof. dr. | Hasselt University | Principal Investigator |
| Leen Heyens, drs. | Hasselt University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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|
| Gamma glutamyltransferase (GGT) | Out of the EPF the blood parameter GGT (U/L) will be collected. | up to year four |
| Lactate dehydrogenase (LDH) | Out of the EPF the blood parameter LDH (U/L) will be collected. | up to year four |
| total protein | Out of the EPF the blood parameter total protein (g/L) will be collected. | up to year four |
| Albumin | Out of the EPF the blood parameter albumin (mg/dL) will be collected. | up to year four |
| Ferritin | Out of the EPF the blood parameter ferritin (µg/L) will be collected. | up to year four |
| bilirubin total | Out of the EPF the blood parameter bilirubin total (mg/dL) will be collected. | 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. | up to year four |
| Weight | The weight (kg) | up to year four |
| Height | The height (m) | 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. | up to year four |
| waist circumference | The waist circumference will be measured and noted in cm. | 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. | 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. | 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. | 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. | 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. | up to year four |
| Diagnosis Diabetes | The year of diagnosis is asked to the patient (yr). | 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. | up to year four |
| urine creatine | urine creatine (mg/dL) | up to year four |
| micro-albumin | micro-albumin (mg/dL) | up to year four |
| albumin/creatine ratio | albumin/creatine ratio (mg/g creat) | up to year four |
| estimated glomerular filtration rate | estimated glomerular filtration rate (ml/min/1,73m²). | up to year four |
| Triglycerides (mg/dL) | Triglycerides (mg/dL) in blood | up to year four |
| HDL (mg/dL) | HDL (mg/dL) in blood | up to year four |
| LDL cholesterol (mg/dL) | LDL cholesterol (mg/dL) in blood | up to year four |
| Total cholesterol (mg/dL). | Total cholesterol (mg/dL) in blood | up to year four |
| thrombocytes | thrombocytes (1000/µL) in blood | up to year four |
| fasting glucose (mg/dL) | fasting glucose (mg/dL) in blood | up to year four |
| partial alpha fetoprotein (AFP) | partial alpha fetoprotein (AFP) in blood | up to year four |
| haemoglobin A1c (%) | haemoglobin A1c (%) in blood | up to year four |
| D044882 |
| Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |