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Status unknownNCT04057287Updated Oct 5, 2023

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

An observational study in Liver Cirrhoses, sponsored by Institute of Liver and Biliary Sciences, India. Status unknown at 1 site in India. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by Institute of Liver and Biliary Sciences, India · Observational

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Family-based
Time perspective
Cross-sectional
Enrollment
670
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

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), 24-hour dietary recall method, physical measurement \& all the comorbidities.

Blood will be collected and analyzed for CBC, LFT, KFT, PT/INR, 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. Controlled Attenuation Parameter and liver stiffness will be measured by using transient elastography. Ultrasound abdomen will be done First degree relatives of indexed patients will be enrolled. First degree relatives who will not accompanying the indexed subject will be contacted telephonically and will be requested to participate in the study.

The data on first degree relative will be collected on similar parameter as of the indexed patient. This will be a cross sectional study.

For each case, 1 healthy controls will be taken. Healthy Control will be identified from the OPD/IPD of ILBS. Liver transplant donors, hospital volunteers, Blood Donors, healthy attendants who are accompanying other patients of different specialties will be enrolled. An informed consent will be taken. The data will be collected on similar parameter as of the indexed patient. This will be case control study.

We will also have disease control (HBV control) for each case enrolled. Subject suffering from Hepatitis B virus related liver cirrhosis will be included as disease control. For each case, 1 disease control will be included. Disease Control will be identified from the OPD/IPD of ILBS. An informed consent will be taken. The data will be collected on similar parameter as of the indexed patient.

Genetic markers and stool microbiota profiling will be done in 30% of the subsets of sample i.e NASH related Cirrhosis, First Degree Relatives, Healthy Control and HBV Disease control.

02

Conditions studied

  • Liver Cirrhoses
03

In context

Lead sponsor

Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.

Browse Institute of Liver and Biliary Sciences, India studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

NASH related Cirrhosis ( Group 1-Index Cases), First Degree Relatives of index case (Group 2), Healthy Controls (Group 3) HBV Disease Controls (Group 4)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion Criteria for NASH related Cirrhosis (Group 1-Index Case)

  1. Age ≥18 yrs
  2. Diagnosed cases of NASH with Cirrhosis.

Exclusion Criteria for NASH related Cirrhosis (Group 1)

  1. Acute on Chronic Liver Failure
  2. Patients with HBV, HCV, Wilson's, Hemochromatosis, alpha 1 antitrypsin deficiency, primary biliary cirrhosis).
  3. Patient on treatment with amiodarone or methotrexate.
  4. Patient with any malignancies
  5. Patient on chemotherapy

Inclusion Criteria for First Degree Relatives (Group 2)

  1. Age ≥8 yrs
  2. All the first degree relatives of index case.

Exclusion Criteria for First Degree Relatives (Group 2)

1. Alcohol intake

Inclusion criteria

Inclusion Criteria for Healthy Control (Group 3)

  1. Age ≥18 yrs
  2. Subjects with no history of any known liver disease
  3. Non-Alcoholic
  4. Matched with Age (+/- 5 yrs.) and Gender

Exclusion criteria

Exclusion Criteria for Healthy Control (Group 3)

1. None

Inclusion Criteria for HBV Disease Control (Group 4)

  1. Age ≥18 yrs
  2. HBV Cirrhosis
  3. Matched with Age (+/- 5 yrs.) and Gender

Exclusion Criteria for HBV Disease Control (Group 4)

  1. Patient with any malignancies
  2. HBV related Liver Fibrosis (≤ F3).
05

Study design

Observational model
Family-based
Time perspective
Cross-sectional
Enrollment
670 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • NASH related Cirrhosis

    Other: No intervention

  • Healthy Controls

    Other: No intervention

  • First Degree Relatives of NASH related Cirrhosis

    Other: No intervention

  • HBV Disease Control

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Physical activity-related risk factors as assessed using the International Physical Activity Questionnaire (IPAQ) between NASH related cirrhosis and their First Degree Relatives.

    Time frame: Day 0

  2. Physical activity-related risk factors as assessed using the International Physical Activity Questionnaire (IPAQ) between NASH related cirrhosis and Healthy Control group.

    Time frame: Day 0

  3. Dietary risk factors as captured by Food Frequency Questionnaire (FFQ) & 24 hour dietary recall method between NASH related cirrhosis and their First Degree Relatives.

    Time frame: Day 0

  4. Dietary risk factors as captured by Food Frequency Questionnaire (FFQ) & 24 hour dietary recall method between NASH related cirrhosis and Healthy Control group

    Time frame: Day 0

  5. Difference in microbiota profiling as done by 16s RNA sequencing technique between NASH related cirrhosis and their First Degree Relatives.

    Time frame: Day 0

  6. Difference in microbiota profiling as done by 16s RNA sequencing technique between NASH related cirrhosis and Healthy Control group

    Time frame: Day 0

  7. Genetic Single Nucleotide Polymorphism (SNP's) and Metabolic parameters in NASH related Cirrhosis patients and their 1st degree relatives.

    Time frame: Day 0

  8. Genetic Single Nucleotide Polymorphism (SNP's) and Metabolic parameters in NASH related Cirrhosis patients and Healthy Control group.

    Time frame: Day 0

  9. Metabolic syndrome as risk factors between NASH cirrhosis and their First Degree Relatives.

    Time frame: Day 0

  10. Metabolic syndrome as risk factors between NASH cirrhosis and healthy Control

    Time frame: Day 0

Secondary outcomes

  1. Proportion of Liver fibrosis among first degree relatives of patients with NASH related Cirrhosis.

    Time frame: Day 0

  2. Physical activity-related risk factors as assessed using the International Physical Activity Questionnaire (IPAQ) between NASH related cirrhosis and HBV disease control.

    Time frame: Day 0

  3. Dietary risk factors as captured by Food Frequency Questionnaire (FFQ) and 24 hours dietary recall method between NASH related cirrhosis and HBV disease control.

    Time frame: Day 0

  4. Difference in microbiota profiling as done by 16s RNA sequencing technique between NASH related cirrhosis and HBV disease control.

    Time frame: Day 0

  5. Genetic Single Nucleotide Polymorphism (SNP's) and Metabolic parameters in NASH related Cirrhosis patients and HBV disease control.

    Time frame: Day 0

  6. Metabolic syndrome as risk factors between NASH cirrhosis and HBV Cirrhosis

    Time frame: Day 0

07

Study locations

1 of 1 sites recruiting
  • Institute of Liver and Biliary Sciences
    New Delhi, National Capital Territory of Delhi 110070, India
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04057287
Lead sponsor
Institute of Liver and Biliary Sciences, India
Responsible party
Sponsor
First posted
Aug 15, 2019
Start date
Sep 18, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Oct 5, 2023

Study contacts

Dr Ankit Bhardwaj, Masters-CR
Contact
bhardwaj.ankit3@gmail.com
01146300000
Dr Ankit Bhardwaj, Masters-CR
principal investigator · Institute of Liver and Biliary Sciences, India

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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