Clinical trial NCT04918732: NAFLD Primary Care
Official title: Identification and Characterization of Non-alcoholic Fatty Liver Disease in Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Cardiovascular Diseases
Type2 Diabetes
Metabolic Syndrome
Overweight and Obesity
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 1470
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Able to understand and sign the informed consent
* Able to speak Dutch
* Between 18-80 years
* BMI \>25 kg/m²
* Having one of the following conditions: 1)overweight, 2) obesity, 3) type 2 diabetes mellitus, 4) cardiovascular diseases (hypertension, atherosclerosis, angina pectoris, ischaemic heart condition, cerebrovascular condition)

Exclusion Criteria:

* Excessive alcohol use (more than 20 g/day for women and 30g/day for men= \>2 glasses alcohol/day for women and \>3 glasses for men)
* Other liver diseases: Hepatitis B virus, Hepatitis C virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, Alpha 1 antitrypsin deficiency
* Secondary causes for steatosis: disorders of lipid metabolism, HCV Genotype 3, total parental nutrition, severe surgical weight loss, medications (amiodarone, tamoxifen, methotrexate, corticosteroids and HAART), lean steatosis, Celiac disease, environmental toxicity
* Pregnancy and breastfeeding.
* A history of bariatric surgery.
* Diagnosis of liver cirrhosis and/or hepatocellular carcinoma.
* Current diagnosis of extrahepatic malignancy(s) or prior diagnosis within last 5 years.
* Individuals about to undergo a surgery or otherwise medical procedure that will interfere with data collection and analyses planned within the current cohort, will initially be excluded from participation, but are offered the opportunity to participate at a later moment in time (e.g., after 3 months are myocardial infarction patients are eligible for participation).

Primary outcomes:
measure: Prevalence of NAFLD in risk groups followed by the general practitioner
timeFrame: 3 years
Secondary outcomes:
measure: To study the risk factor overweight in the development of NAFLD
timeFrame: 3 years
measure: To study the risk factor obesity in the development of NAFLD
timeFrame: 3 years
measure: To study the risk factor metabolic syndrome in the development of NAFLD
timeFrame: 3 years
measure: To study the risk factor type 2 diabetes mellitus in the development of NAFLD
timeFrame: 3 years
measure: To study the risk factor cardiovascular diseases in the development of NAFLD
timeFrame: 3 years
measure: To assess if the patient has a depression
timeFrame: 3 years
measure: To assess if the patient has a anxiety issues
timeFrame: 3 years
measure: To assess if the general wellbeing of the patient.
timeFrame: 3 years
measure: To assess the physical state of the patient.
timeFrame: 3 years
measure: To assess the work productivity and absenteism of the patient.
timeFrame: 3 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References: