Characteristics of NAFLD Among Type 2 Diabetes Patients

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Characteristics of Non-Alcoholic Fatty Liver Disease (NAFLD) in Type 2 Diabetes Mellitus Patients Followed in a Hospital Environment in Flanders, Belgium

Conditions
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Non-Alcoholic Fatty Liver Disease, Type2 Diabetes

Intervention / Treatment
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* Other: Screening and studying characteristics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Type 2 Diabetes Mellitus patients<br> | Other: Screening and studying characteristics<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD, NAFLD, characteristics, type 2 diabetes, hospital