About Us

Introduction

Non‐alcoholic liver disease (NAFLD) is a spectrum ranging from non‐alcoholic fatty liver (NAFL) to non‐alcoholic steatohepatitis (NASH), which has the propensity to progress to liver cirrhosis and hepatocellular carcinoma (HCC). 1 Rather than affecting only the liver, NAFLD is now recognized as a multisystem disease and has been associated with not only increased liver‐related morbidity and mortality but also with increased morbidity‐ and mortality‐related cardiovascular disease, chronic kidney disease, osteoporosis, and extrahepatic malignancy. 2 NAFLD has now become the most common liver disease the world over, affecting up to one fourth of the global population; the prevalence, however, may differ from country to country and region to region. 3 The general population prevalence in the Western world may be slightly higher than the Asia Pacific. 4 Within the Asia Pacific, there are countries with higher and lower prevalence. 5Within the Asia Pacific, Asian‐Indians are somehow more susceptible to insulin resistance (even at lower BMI) and thus to NAFLD. This fact has been established in various multiracial studies and may have a genetic basis. 6-8 Studies from India have shown variable prevalence, with major difference between rural and urban parts of the country. 9-14

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.

References

1. Duseja A, Sharma B, Kumar A et al . Nonalcoholic fatty liver in a developing country is responsible for significant liver disease. Hepatology. 2010; 52: 2248– 9.
2. Byrne CD, Targher G. NAFLD: a multisystem disease. J. Hepatol. 2015; 62(1 Suppl): S47– 64.
3. Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease‐Meta‐analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016; 64: 73– 84
4. Duseja A, Chalasani N. Epidemiology and risk factors of nonalcoholic fatty liver disease (NAFLD). Hepatol. Int. 2013; 7(Suppl. 2): 755– 64
5. Wong VW, Chan WK, Chitturi S et al . The Asia‐Pacific Working Party on Nonalcoholic Fatty Liver Disease Guidelines 2017 Part 1: Definition, risk factors and assessment. J. Gastroenterol. Hepatol. 2018; 33: 70– 85.
6. Petersen KF, Dufour S, Feng J et al . Increased prevalence of insulin resistance and nonalcoholic fatty liver disease in Asian‐Indian men. Proc. Natl. Acad. Sci. U. S. A. 2006; 103: 18273– 7.
7. Goh SC, Ho EL, Goh KL. Prevalence and risk factors of non‐alcoholic fatty liver disease in a multiracial suburban Asian population in Malaysia. Hepatol. Int. 2013; 7: 548– 54.
8. Chan WK, Bahar N, Razlan H, Vijayananthan A, Sithaneshwar P, Goh KL. Non‐alcoholic fatty liver disease in a young multiracial Asian population: a worrying ethnic predilection in Malay and Indian males. Hepatol. Int. 2014; 8: 121– 7.
9. Das K, Das K, Mukherjee PS et al . Nonobese population in a developing country has a high prevalence of nonalcoholic fatty liver and significant liver disease. Hepatology. 2010; 51: 1593– -602
10. Amarapurkar D, Kamani P, Patel N et al . Prevalence of non‐alcoholic fatty liver disease: population based study. Ann. Hepatol. 2007; 6: 161– 3.
11. Singh SP, Nayak S, Swain M et al . Prevalence of nonalcoholic fatty liver disease in coastal eastern India: a preliminary ultrasonographic survey. Trop. Gastroenterol. 2004; 25: 76– -9
12. Mohan V, Farooq S, Deepa M, Ravikumar R, Pitchumoni CS. Prevalence of non‐alcoholic fatty liver disease in urban south Indians in relation to different grades of glucose intolerance and metabolic syndrome. Diabetes Res. Clin. Pract. 2009; 84: 84– 91.
13. Duseja A, Singh SP, Saraswat VA, Acharya SK, Chawla YK, Chowdhury S, et al. Non-alcoholic fatty liver disease and metabolic syndrome-position paper of the Indian National Association for the Study of the Liver, Endocrine society of India, Indian college of Cardiology and Indian society of Gastroenterology. J Clin Exp Hepatol. 2015; 5:51–68.
14. Duseja A, Najmy S, Sachdev S, Pal A, Sharma RR, Marwah N et al. High prevalence of non-alcoholic fatty liver disease among healthy male blood donors of urban India. JGH Open 2019; 3(2):133-139.

Aim

To evaluate the ‘real life’ hospital based spectrum and severity, clinico-pathological profile, treatment and follow up of Indian patients with NAFLD.

Objectives

  • To study the ‘real life’ hospital based spectrum of NAFLD patients
  • Nonalcoholic fatty liver (NAFL)
  • Nonalcoholic steatohepatitis (NASH)
  • NASH related cirrhosis
  • NASH related Hepatocellular carcinoma (HCC).
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  • To evaluate the metabolic risk factors in patients with NAFLD.
  • To evaluate the severity of liver disease in patients with NAFLD.
  • To record the details of ‘real life’ treatment - lifestyle modifications or lifestyle modifications plus medications.
  • To record the details of ‘real life’ treatment - lifestyle modifications or lifestyle modifications plus medications. To record the hepatic/extra-hepatic events on follow up - NAFL, NASH and compensated NASH related cirrhosis

Methodology

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
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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
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Participating Centers