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Risk Factors of Liver Fibrosis Among First Degree Relatives of Patients With NASH Related Cirrhosis (NRC)

NCT04057287 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 670

Last updated 2023-10-05

No results posted yet for this study

Summary

The study aim to identify the risk factors of liver fibrosis among first degree relatives. This study consists of 2 parts (Cross Sectional and Case Control Study).

Part 1: The first primary objective will be achieved by following study design. Study population: First degree relatives of NRC. Study design: A Cross Sectional Study

Part 2 The second Primary objective will be achieved by following study design. Study design: A Case Control Study

Study population:

Case: NASH related Cirrhosis patients Control-1: Healthy Control. Control-2: HBV Disease Control Study period: 3 Years

All the patients diagnosed with NASH cirrhosis attending Institute of Liver and Biliary Sciences OPD/IPD will be enrolled. An informed consent will be taken. Complete details of the subject will be taken. The data will be collected on socio-demographic by (socio-demographic questionnaire), alcohol by AUDIT-C (Alcohol Use Disorders Identification Test), Tobacco by FTND (Fagerstrom Test Nicotine Dependence), physical activity by IPAQ (International Physical Activity Questionnaire), Diet by FFQ (Food Frequency Questionnaire), physical measurement \& all the comorbidities.

Blood will be collected and analyzed for Platelets, PT/INR, Serum Creatinine, LFT, FBS, HOMA-IR, Lipid Profile, HBsAg, AntiHBs, Anti HBc, Anti HCV, Anti HAV, IgM anti HAV, IgM anti HEV, auto-Immune markers, Ceruloplasmin, Transferrin, S.Ferritin, Alpha1antitrpsin and genetic markers.

The stool will be collected and analyzed for gut microbiota profiling.

Conditions

  • Liver Cirrhoses

Interventions

OTHER

No intervention

No intervention

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Principal Investigators

  • Dr Ankit Bhardwaj, Masters-CR · Institute of Liver and Biliary Sciences

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-18
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04057287 on ClinicalTrials.gov