NAFLD Primary Care

  • STATUS
    Recruiting
  • End date
    May 1, 2023
  • participants needed
    1470
  • sponsor
    Maastricht University
Updated on 23 June 2021
atherosclerosis
diabetes
cancer
hypertension
type 2 diabetes mellitus
angina pectoris
liver disease
fatty liver
steatosis
fats

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.

Details
Condition Non-alcoholic Fatty Liver Disease, cardiovascular disorders, Overweight and Obesity, non-alcoholic fatty liver, Metabolic Disorders, cardiovascular system diseases, Cardiovascular Disease, cardiovascular diseases, Type2 Diabetes, metabolic syndrome x, Nonalcoholic Fatty Liver Disease, Metabolic Syndrome, NAFLD, Metabolic disorder, Non Alcoholic Fatty Liver Disease, Metabolic syndrome, Nonalcoholic Steatohepatitis (NASH), cardiovascular disease (cvd)
Treatment Fibroscan
Clinical Study IdentifierNCT04918732
SponsorMaastricht University
Last Modified on23 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to understand and sign the informed consent
Able to speak Dutch
Between 18-80 years
BMI >25 kg/m
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)
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