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Non-alcoholic fatty liver disease (NAFLD) is with 25% the most prevalent liver disorder in Western society and is associated with overweight, obesity, metabolic syndrome (MetS), type 2 diabetes mellitus (T2DM), cardiovascular diseases (CVD) and increased risk of cancer development. NAFLD is defined by a hepatic fat accumulation of more than 5% in the absence of classical causes of steatogenesis (e.g. alcohol and steatogenic drugs). It represents a broad spectrum of clinical entities from non-alcoholic fatty liver (NAFL) to advanced liver disease with hepatic failure. Most of the patients have simple steatosis, however in about 15-30% non-alcoholic steatohepatitis (NASH) develops, which leads to an overall increase in morbidity and mortality due to the progression to fibrosis, cirrhosis and hepatocellular carcinoma (HCC). Patients with NAFLD have no or few, mainly aspecific symptoms; and generally there is a silent progression of simple steatosis to NASH and in the end liver-related morbidity and mortality. Despite the clinical importance and the potential impact on healthcare resources, there is a striking lack of awareness on all levels of NAFLD. Furthermore, little to know data are available concerning the quality of life of NAFLD patients. Additionally, the majority of NAFLD patients are currently not detected due to the lack of non-invasive methods to diagnose NAFLD. Most of these patients, as a first contact in the healthcare system, will be found in the outpatient clinic of the general practitioner (GP). To date, it is not clear what the burden is of NAFLD and related diseases in at risk subjects in primary care. Therefore, identification of NAFLD patients in this cohort will give information on the prevalence in the group of uncomplicated overweight and obesity and those with concomitant cardiometabolic diseases. By early detecting these patients at risk to develop progressive liver diseases and extrahepatic manifestations, it will be possible to intervene and improve health.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FibroScan | Diagnostic Test | The FibroScan device developed by Echosens (France) measures the liver stifness and steatosis based on a pulse of sound waves that goes through the liver. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of NAFLD in risk groups followed by the general practitioner | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To study the risk factor overweight in the development of NAFLD | To see if there is an effect of having a BMI between 25 and 30 kg/m² in the development of NAFLD. The physiological parameter used will be BMI. | 3 years |
| To study the risk factor obesity in the development of NAFLD |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Recruiting | Maastricht | Limburg | Netherlands |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D002318 | Cardiovascular Diseases |
| D024821 | Metabolic Syndrome |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007333 | Insulin Resistance |
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To see if there is an effect of having a BMI between 30-40 kg/m² on the development of NAFLD. The physiological parameter used will be BMI. |
| 3 years |
| To study the risk factor metabolic syndrome in the development of NAFLD | To see if there is an effect of metabolic syndrome (defined by the criteria of the International Diabetes Federation) on the development of NAFLD. | 3 years |
| To study the risk factor type 2 diabetes mellitus in the development of NAFLD | Type 2 diabetes mellitus will be assessed based on previous diagnosis and HbA1c levels. | 3 years |
| To study the risk factor cardiovascular diseases in the development of NAFLD | Cardiovascular diseases will be assessed based on medical history found in the EPF. | 3 years |
| To assess if the patient has a depression | Depression will be assessed using the patient-health questionnaire 9 (PHQ-9). | 3 years |
| To assess if the patient has a anxiety issues | Anxiety will be assessed using the general anxiety disorder questionnaire (GAD-7) | 3 years |
| To assess if the general wellbeing of the patient. | General wellbeing will be assessed using the short-health form-36 (SF-36). | 3 years |
| To assess the physical state of the patient. | The physical state will be assessed using the BAECKE questionnaire. | 3 years |
| To assess the work productivity and absenteism of the patient. | The work productivity will be assessed using the WPAI-SHP questionnaire. | 3 years |
| D006946 |
| Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |