Liver CirrhosesNCT04057287
Risk Factors of Liver Fibrosis Among First Degree Relatives of Patients With NASH Related Cirrhosis (NRC)
An observational study of Liver Cirrhoses, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Cirrhoses
- How many people
- 670 participants
- Where
- 1 siteIndia
- Study dates
- 18 Sep 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- Age ≥8 yrs
- All the first degree relatives of index case.
- Age ≥18 yrs
- Subjects with no history of any known liver disease
- Non-Alcoholic
- Matched with Age (+/- 5 yrs.) and Gender
Show all 9Show fewer
- Age ≥18 yrs
- HBV Cirrhosis
- Matched with Age (+/- 5 yrs.) and Gender
Who cannot join
- 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
- 1. Alcohol intake
Show all 9Show fewer
- 1. None
- Patient with any malignancies
- HBV related Liver Fibrosis (≤ F3).
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Ankit Bhardwaj, Masters- CR, 01146300000, bhardwaj.ankit3@gmail.com
About this study
Official title: Risk Factors of Liver Fibrosis Among First Degree Relatives of Patients With NASH Related Cirrhosis (NRC).
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
Read more
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.
- Conditions
- Liver Cirrhoses
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| NASH related Cirrhosis | Not described Receives: Other: No intervention | |
| Healthy Controls | Not described Receives: Other: No intervention | |
| First Degree Relatives of NASH related Cirrhosis | Not described Receives: Other: No intervention | |
| HBV Disease Control | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity-related risk factors as assessed using the International Physical Activity Questionnaire (IPAQ) between NASH related cirrhosis and their First Degree Relatives.
Measured: Day 0
Physical activity-related risk factors as assessed using the International Physical Activity Questionnaire (IPAQ) between NASH related cirrhosis and Healthy Control group.
Measured: 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.
Measured: 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
Measured: Day 0
Difference in microbiota profiling as done by 16s RNA sequencing technique between NASH related cirrhosis and their First Degree Relatives.
Measured: Day 0
Difference in microbiota profiling as done by 16s RNA sequencing technique between NASH related cirrhosis and Healthy Control group
Measured: Day 0
Genetic Single Nucleotide Polymorphism (SNP's) and Metabolic parameters in NASH related Cirrhosis patients and their 1st degree relatives.
Measured: Day 0
Genetic Single Nucleotide Polymorphism (SNP's) and Metabolic parameters in NASH related Cirrhosis patients and Healthy Control group.
Measured: Day 0
Metabolic syndrome as risk factors between NASH cirrhosis and their First Degree Relatives.
Measured: Day 0
Metabolic syndrome as risk factors between NASH cirrhosis and healthy Control
Measured: Day 0
Secondary outcomes (6)
Proportion of Liver fibrosis among first degree relatives of patients with NASH related Cirrhosis.
Measured: Day 0
Physical activity-related risk factors as assessed using the International Physical Activity Questionnaire (IPAQ) between NASH related cirrhosis and HBV disease control.
Measured: 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.
Measured: Day 0
Difference in microbiota profiling as done by 16s RNA sequencing technique between NASH related cirrhosis and HBV disease control.
Measured: Day 0
Genetic Single Nucleotide Polymorphism (SNP's) and Metabolic parameters in NASH related Cirrhosis patients and HBV disease control.
Measured: Day 0
Metabolic syndrome as risk factors between NASH cirrhosis and HBV Cirrhosis
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start18 Sep 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosesStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Ankit Bhardwaj, Masters-CR, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057287
- Sponsor's protocol ID
- ILBS-NRC-01
- Status last verified
- Oct 2023
- First submitted
- 13 Jun 2019
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Liver Fibrosis Among First Degree Relatives of Patients With NASH Related Cirrhosis (NRC).
- ClinicalTrials.gov ID
- NCT04057287
- Acronym / sponsor ID
- ILBS-NRC-01
- Conditions
- Liver Cirrhoses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (9 listed)
- Age ≥8 yrs
- All the first degree relatives of index case.
- Age ≥18 yrs
- Subjects with no history of any known liver disease
- Non-Alcoholic
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | First Degree Relatives of NASH related Cirrhosis, HBV Disease Control, Healthy Controls, NASH related Cirrhosis |
Primary outcome
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
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
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
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
Difference in microbiota profiling as done by 16s RNA sequencing technique between NASH related cirrhosis and their First Degree Relatives.
Time frame: Day 0
Difference in microbiota profiling as done by 16s RNA sequencing technique between NASH related cirrhosis and Healthy Control group
Time frame: Day 0
Genetic Single Nucleotide Polymorphism (SNP's) and Metabolic parameters in NASH related Cirrhosis patients and their 1st degree relatives.
Time frame: Day 0
Genetic Single Nucleotide Polymorphism (SNP's) and Metabolic parameters in NASH related Cirrhosis patients and Healthy Control group.
Time frame: Day 0
Metabolic syndrome as risk factors between NASH cirrhosis and their First Degree Relatives.
Time frame: Day 0
Metabolic syndrome as risk factors between NASH cirrhosis and healthy Control
Time frame: Day 0
6 secondary outcomes
Proportion of Liver fibrosis among first degree relatives of patients with NASH related Cirrhosis.
Time frame: Day 0
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
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
Difference in microbiota profiling as done by 16s RNA sequencing technique between NASH related cirrhosis and HBV disease control.
Time frame: Day 0
Genetic Single Nucleotide Polymorphism (SNP's) and Metabolic parameters in NASH related Cirrhosis patients and HBV disease control.
Time frame: Day 0
Metabolic syndrome as risk factors between NASH cirrhosis and HBV Cirrhosis
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Ankit Bhardwaj, Masters-CR principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhoses, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Ankit Bhardwaj, Masters-CR (01146300000, bhardwaj.ankit3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.