Disease mechanisms and markers for non-alcoholic steatohepatitis in a population with non-alcoholic fatty liver disaese: a prospective cohort study with biobank

Disease mechanisms and markers for non-alcoholic steatohepatitis in a population with non-alcoholic fatty liver disaese: a prospective cohort study with biobank - Prospective cohort and biobank of nonalcoholic fatty liver disease patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47388

Enrollment

500

Registered

2015-03-25

Start date

2015-02-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fatty liver Non-alcoholic fatty liver disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - NAFLD diagnosis based on evidence of hepatic steatosis, either by imaging (any form) or by histology - BMI >= 25 - Between 18 - 65 years of age

Exclusion criteria

Exclusion criteria: - Incompetent to understand and/or sign the informed consent. - Causes for secondary hepatic fat accumulation such as significant alcohol consumption, medications, Wilson*s disease, viral infections, starvation or parenteral nutrition, among others, and conditions associated with microvesicular steatosis (excluding hemochromatosis) - Ethanol consumption exceeding more than 14 standard beverages per week for males and more than 7 standard beverages per week for female. - Unwilling to collect biosamples - Pregnancy and breastfeeding. - A history of bariatric surgery. - Diagnosis of liver cirrhosis and/or hepatocellular carcinoma. - Diagnosis of extrahepatic malignancies - Individuals about to undergo or recovering from a surgical 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).

Design outcomes

Primary

Measure	Time frame
The primary outcome of this cohort is the diagnosis NASH	—

Secondary

Measure	Time frame
Furthermore different parameters ([epi-]genetic, lifestyle, metabolic, inflammatory and microbial parameters) associated with NASH in a cohort NAFLD patients will be investigated cross-sectionally and longitudinally. The degree of hepatic steatosis and/or fibrosis (e.g. using MRI and Fibroscan) and the presence of hepatic inflammation (e.g. using biochemical parameters and MRI) will be assessed. Additionally, the prevalence of (extra)hepatic complications of NAFLD will be evaluated.	—

Measure

Time frame

Furthermore different parameters ([epi-]genetic, lifestyle, metabolic, inflammatory and microbial parameters) associated with NASH in a cohort NAFLD patients will be investigated cross-sectionally and longitudinally. The degree of hepatic steatosis and/or fibrosis (e.g. using MRI and Fibroscan) and the presence of hepatic inflammation (e.g. using biochemical parameters and MRI) will be assessed. Additionally, the prevalence of (extra)hepatic complications of NAFLD will be evaluated.

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Countries

Netherlands

Outcome results