Alcohol-related Liver DiseaseNCT06763198
Genetic Polymorphisms Associated With the Risk of Pancreatitis in Patients With Alcohol Related Cirrhosis.
An observational study of Alcohol-related Liver Disease, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Alcohol is a known risk factor for both pancreatitis and cirrhosis. However, not all patients with alcohol related cirrhosis develop pancreatitis. It is not known which patients with alcohol-related cirrhosis develop symptomatic or clinically inapparent pancreatitis (Acute or Chronic Pancreatitis).There is no data… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol-related Liver Disease
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 25 Jan 2025to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: * Patients > 18 years of age. * Who have either alcohol related or non alcohol related cirrhosis.
Who may be able to join
- Patients > 18 years of age.
- Alcohol-related cirrhosis
- Males
Who cannot join
- Current Hepatic encephalopathy or cognitive dysfunction precluding adequate nutritional and functional assessment.
- HCC.
- Complete or partial PVT.
- Significant cardio-pulmonary comorbidity
- Patients who do not consent for genetic study
- Inability to provide informed consent.
- Cannot understand Hindi or English should be excluded since they will not be able to reply objectively to questionnaire.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, 110070
Dr Aakula Suguna Sree, MD, 01146300000, sugunasreeaakula@gmail.com
About this study
Alcohol is a known risk factor for both pancreatitis and cirrhosis. However, not all patients with alcohol related cirrhosis develop pancreatitis. It is not known which patients with alcohol-related cirrhosis develop symptomatic or clinically inapparent pancreatitis (Acute or Chronic Pancreatitis).There is no data whether genetic polymorphisms predispose patients with alcohol-related cirrhosis to additional pancreatic injury. There is no data on the spectrum of clinical and subclinical pancreatic changes (structural and functional) in patients with alcohol-related cirrhosis, and their genotypic correlates.This study aims to determine pancreatitis-related gene variants among patients with alcohol-related cirrhosis, with and without pancreatitis. We also aim to study differences in nutritional and functional parameters among alcoholic cirrhosis with and without chronic pancreatitis and also define the relationship of genetic polymorphisms with the pancreatic phenotype. Consecutive patients with alcohol related cirrhosis will be screened for changes of pancreatitis on CT/MR/EUS. Those with and without pancreatitis will be compared with respect to demographic, clinical, genotype, nutritional status .We will also be including a group of MAFLD/Cryptogenic cirrhosis for genotypic and phenotypic comparison.
Read the detailed description
Aim and Objective - To determine pancreatitis-related gene variants among patients with alcohol-related cirrhosis, with and without pancreatitis.
Primary objective: To determine the genetic variants associated with morphological and functional pancreatic changes among patients with alcohol-related cirrhosis.
Secondary objectives
- To define the relationship of genetic polymorphisms with the pancreatic phenotype.*
- To study differences in nutritional and functional parameters among alcoholic cirrhosis with and without chronic pancreatitis.
Hypothesis -
- Genetic polymorphisms related to pancreatitis predispose patients with alcohol-related cirrhosis to additional pancreatic injury.
Associated chronic pancreatitis (clinically apparent or subclinical) negatively influences the nutritional and functional status of patients with alcohol-related cirrhosis
- Study design: Cross sectional study of two study cohorts
- Study period: 1 year.
- Sample size with justification: Studies have reported pathogenic SPINK 1 mutations in 25% -50.0% among idiopathic CP and 10-20% in acute pancreatitis as compared to 1%-4.7% among controls. The investigator assume pathogenic SPINK 1 mutation frequency of 50% and 1% among alcohol-related cirrhosis with and without CP, respectively. The investigator also assume a 33% prevalence of CP among alcohol-related cirrhosis. With significance (α) at 0.5, power of 80%, investigator need to enroll 100 patients of alcohol-related cirrhosis.The investigator will also include a cohort of 50 males with cirrhosis of other etiologies.
- Conditions
- Alcohol-related Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol-related cirrhosis | Alcohol-related cirrhosis | |
| Liver cirrhosis of other etiologies | Liver cirrhosis of other etiologies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic polymorphisms in one or more pancreatitis-associated genes* among patients with alcohol-related cirrhosis, with and without pancreatitis.
Measured: Day 0
Secondary outcomes (8)
Differences in genetic polymorphisms in one or more pancreatitis related genes in patients with pancreatitis between alcohol related cirrhosis and cirrhosis of other etiologies.
Measured: Day 0
To define the relationship of genetic polymorphisms with the pancreatic phenotype.*
Measured: Day 0
Prevalence of pancreatitis defined by CT/MR/EUS among patients with alcohol-related cirrhosis.
Measured: Day 0
Difference in prevalence of pancreatitis defined by CT/MR/EUS among patients with alcohol-related cirrhosis and cirrhosis of other etiologies .
Measured: Day 0
Severe exocrine insufficiency defined by fecal elastase <100µg/g stool among cirrhotic patients with and without chronic pancreatitis
Measured: Day 0
Endocrine insufficiency defined by FBS >126mg/dl and HbA1c >6.5% among cirrhotic patients with and without chronic pancreatitis.
Measured: Day 0
Sarcopenia defined by Skeletal muscle index of < 50cm/m2 in men on CT, and/or 7.0 kg/m2 on DEXA among cirrhotic patients with and without chronic pancreatitis.
Measured: Day 0
Liver frailty index > 4.5
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 posted8 Jan 2025
- Study start25 Jan 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-related Liver DiseaseStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763198
- Sponsor's protocol ID
- ILBS-Cirrhosis-71
- Status last verified
- Dec 2024
- First submitted
- 1 Jan 2025
- Last updated
- 22 Jan 2025
- 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphisms Associated With the Risk of Pancreatitis in Patients With Alcohol Related Cirrhosis.
- ClinicalTrials.gov ID
- NCT06763198
- Acronym / sponsor ID
- ILBS-Cirrhosis-71
- Conditions
- Alcohol-related Liver Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 25 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 8 Jan 2025 (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.
Alcohol is a known risk factor for both pancreatitis and cirrhosis. However, not all patients with alcohol related cirrhosis develop pancreatitis. It is not known which patients with alcohol-related cirrhosis develop symptomatic or clinically inapparent pancreatitis (Acute or Chronic Pancreatitis).There is no data whether genetic polymorphisms predispose patients with alcohol-related cirrhosis to additional pancreatic injury. There is no data on the spectrum of clinical and subclinical pancreatic changes (structural and functional) in patients with alcohol-related cirrhosis, and their genotypic correlates.This study aims to determine pancreatitis-related gene variants among patients with alcohol-related cirrhosis, with and without pancreatitis. We also aim to study differences in nutritional and functional parameters among alcoholic cirrhosis with and without chronic pancreatitis and also define the relationship of genetic polymorphisms with the pancreatic phenotype. Consecutive patients with alcohol related cirrhosis will be screened for changes of pancreatitis on CT/MR/EUS. Those with and without pancreatitis will be compared with respect to demographic, clinical, genotype, nutritional status .We will also be including a group of MAFLD/Cryptogenic cirrhosis for genotypic and phenotypic comparison.
Detailed description
Aim and Objective - To determine pancreatitis-related gene variants among patients with alcohol-related cirrhosis, with and without pancreatitis.
Primary objective: To determine the genetic variants associated with morphological and functional pancreatic changes among patients with alcohol-related cirrhosis.
Secondary objectives
- To define the relationship of genetic polymorphisms with the pancreatic phenotype.*
- To study differences in nutritional and functional parameters among alcoholic cirrhosis with and without chronic pancreatitis.
Hypothesis -
- Genetic polymorphisms related to pancreatitis predispose patients with alcohol-related cirrhosis to additional pancreatic injury.
Associated chronic pancreatitis (clinically apparent or subclinical) negatively influences the nutritional and functional status of patients with alcohol-related cirrhosis
- Study design: Cross sectional study of two study cohorts
- Study period: 1 year.
- Sample size with justification: Studies have reported pathogenic SPINK 1 mutations in 25% -50.0% among idiopathic CP and 10-20% in acute pancreatitis as compared to 1%-4.7% among controls. The investigator assume pathogenic SPINK 1 mutation frequency of 50% and 1% among alcohol-related cirrhosis with and without CP, respectively. The investigator also assume a 33% prevalence of CP among alcohol-related cirrhosis. With significance (α) at 0.5, power of 80%, investigator need to enroll 100 patients of alcohol-related cirrhosis.The investigator will also include a cohort of 50 males with cirrhosis of other etiologies.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcohol-related cirrhosis | – | –Alcohol-related cirrhosis |
| Liver cirrhosis of other etiologies | – | –Liver cirrhosis of other etiologies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients > 18 years of age. * Who have either alcohol related or non alcohol related cirrhosis.
Key inclusion criteria (3 listed)
- Patients > 18 years of age.
- Alcohol-related cirrhosis
- Males
Key exclusion criteria (7 listed)
- Current Hepatic encephalopathy or cognitive dysfunction precluding adequate nutritional and functional assessment.
- HCC.
- Complete or partial PVT.
- Significant cardio-pulmonary comorbidity
- Patients who do not consent for genetic study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic polymorphisms in one or more pancreatitis-associated genes* among patients with alcohol-related cirrhosis, with and without pancreatitis.
Time frame: Day 0
8 secondary outcomes
Differences in genetic polymorphisms in one or more pancreatitis related genes in patients with pancreatitis between alcohol related cirrhosis and cirrhosis of other etiologies.
Time frame: Day 0
To define the relationship of genetic polymorphisms with the pancreatic phenotype.*
Time frame: Day 0
Prevalence of pancreatitis defined by CT/MR/EUS among patients with alcohol-related cirrhosis.
Time frame: Day 0
Difference in prevalence of pancreatitis defined by CT/MR/EUS among patients with alcohol-related cirrhosis and cirrhosis of other etiologies .
Time frame: Day 0
Severe exocrine insufficiency defined by fecal elastase <100µg/g stool among cirrhotic patients with and without chronic pancreatitis
Time frame: Day 0
Endocrine insufficiency defined by FBS >126mg/dl and HbA1c >6.5% among cirrhotic patients with and without chronic pancreatitis.
Time frame: Day 0
Sarcopenia defined by Skeletal muscle index of < 50cm/m2 in men on CT, and/or 7.0 kg/m2 on DEXA among cirrhotic patients with and without chronic pancreatitis.
Time frame: Day 0
Liver frailty index > 4.5
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- 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.
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 Alcohol-related Liver Disease, 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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 22 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Aakula Suguna Sree, MD (01146300000, sugunasreeaakula@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic polymorphisms in one or more pancreatitis-associated genes* among patients with alcohol-related cirrhosis, with and without pancreatitis. (time frame: Day 0). 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 22 Jan 2025.