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

NCT04057287 | Unknown

• 1 other identifier: ILBS-NRC-01
• Study Type: observational
• Target: 670
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (10)

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

  Day 0

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

  Day 0

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

  Day 0

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

  Day 0

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

  Day 0

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

  Day 0

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

  Day 0

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

  Day 0

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

  Day 0

• Metabolic syndrome as risk factors between NASH cirrhosis and healthy Control

  Day 0

Secondary Outcomes (6)

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

  Day 0

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

  Day 0

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

  Day 0

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

  Day 0

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

  Day 0

Study Arms (4)

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

No intervention OTHER

No intervention

First Degree Relatives of NASH related Cirrhosis; HBV Disease Control; Healthy Controls; NASH related Cirrhosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Age ≥18 yrs
• Diagnosed cases of NASH with Cirrhosis.

You may not qualify if:

• Acute on Chronic Liver Failure
• Patients with HBV, HCV, Wilson's, Hemochromatosis, alpha 1 antitrypsin deficiency, primary biliary cirrhosis).
• Patient on treatment with amiodarone or methotrexate.
• Patient with any malignancies
• Patient on chemotherapy
• Age ≥8 yrs
• All the first degree relatives of index case.
• \. Alcohol intake
• Age ≥18 yrs
• Subjects with no history of any known liver disease
• Non-Alcoholic
• Matched with Age (+/- 5 yrs.) and Gender
• \. None
• Age ≥18 yrs
• HBV Cirrhosis

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Genetic markers like PNPLA3,TM6SF2,SAMM50, PARVB

Study Officials

• Dr Ankit Bhardwaj, Masters-CR

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Ankit Bhardwaj, Masters-CR

CONTACT

01146300000; bhardwaj.ankit3@gmail.com

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2019
• First Posted: August 15, 2019
• Study Start: September 18, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

IN (1)