Identification and characterization of non-alcoholic fatty liver disease in primary care.

Recruiting

• Conditions: fatty liver; Non-alcoholic fatty liver disease; 10018424; 10019654; 10003018

• Registration Number: NL-OMON54037
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1468

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)

Additional inclusion criteria valid only for the other food additives and
limonene breath test
• All those listed in the main protocol +
• NAFLD F2-F3-F4 fibrosis stage (FibroScan >= 7.5 kPa)
• Capability to complete an overnight fasting (>=10h)
• Willingness to share data with Owlstone Medical LTD.

Exclusion Criteria

Excessive alcohol use
o more than 20 g/day for women and 30g/day for men
o >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).

Additional inclusion criteria valid only for the other food additives and
limonene breath test
• All those listed in the main protocol +
• Inability to complete the breath sampling procedure
• Known carrier of a-1 Antitrypsin deficiency

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this cohort is the diagnosis of NAFLD with fibrosis. </p><br>