ICON D Study aims to bridge the gap in consolidated NAFLD / NASH epidemiological studies from India . Even though there is a high prevalence of nonalcoholic fatty liver disease (NAFLD) in India, the data on prevalence, clinicopathological profile, treatment and follow up is small & region specific The Indian Consortium on Nonalcoholic Fatty Liver Disease [ICON-D] – conceived in 2017 in association with the INASL NAFLD Task Force. The information collected through ICON D Study will be critical in providing a baseline to measure the impact of current & emerging therapies in NASH / NAFLD and also be significant in establishing a large diverse registry of NAFLD Patients which can be leveraged to further our collective understanding of the disease, effective modes of treatment and outcomes across the spectrum of NAFLD/NASH/HCC.
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To evaluate the ‘real life’ hospital based spectrum and severity, clinico-pathological profile, treatment and follow up of Indian patients with NAFLD.
- Nonalcoholic fatty liver (NAFL)
- Nonalcoholic steatohepatitis (NASH)
- NASH related cirrhosis
- NASH related Hepatocellular carcinoma (HCC).
Three year, prospective, ‘real life’ study.
Participating centers chosen based on the feasibility questionnaire.
- Respective Institute’s ethical approvals
- Academic and Non-academic
- Public and Private
- Adolescents (12-18yrs) and adults (> 18 yrs) after informed consent/Assent
Online – Electronic data capture (EDC) study (Oracle software – Tech Observer)
- Pre-defined inclusion and exclusion criteria – Fatty liver on imaging with exclusion of alcohol and other etiologies
- Metabolic syndrome components
- Non-invasive assessment (USG/CT/MRI, ALT, APRI, NFS, TE) – NAFL, NASH, Cirrhosis, HCC
- Severity of hepatic steatosis, inflammation and fibrosis on noninvasive assessment
- Liver biopsy – optional
- Treatment being received – as per the discretion of the treating physician
- Follow up – Hepatic and Extra-hepatic events in all except decompensated cirrhosis and HCC
- Storage of blood samples – optional