Liver DiseasesNCT05028842
Effect of Lockdown During COVID 19 Pandemic on Liver Disease and Metabolic Parameters.
An observational study of Liver Diseases, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The novel corona virus disease (COVID-19), pandemic has costed lives of several hundred thousands and affected millions. Comorbidities such as metabolic syndrome components and chronic liver disease have been associated with more severe infection and increased risk of death in this pandemic. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Diseases
- How many people
- 230 participants
- Where
- 1 siteIndia
- Study dates
- 30 Aug 2021to 6 Sep 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of liver disease attending the OPD with one visit before implementation of lockdown and the other during the lockdown phase
Who may be able to join
- Patients of liver disease attending the OPD.
Who cannot join
- Patients without atleast 2 fibroscan examination (one before lockdown and the other after lockdown implementation).
- Acute self-limiting hepatitis.
- Sick patients requiring hospital admission.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
The novel corona virus disease (COVID-19), pandemic has costed lives of several hundred thousands and affected millions. Comorbidities such as metabolic syndrome components and chronic liver disease have been associated with more severe infection and increased risk of death in this pandemic. Several measures have been taking by the governments across the world. An important step taken by the Indian government was the temporary lockdown of the whole country starting from 25th March 2020 till 31st May. This was followed by relaxation in phases across the country. Lockdown and social distancing helped in controlling the pandemic, but had enormous impact on health of non-COVID patients, economics and social life. Impact of lockdown COVID-19 on metabolic control in type 2 diabetes mellitus and healthy people is studied. However, the impact on liver disease patients is not known.
Read the detailed description
Aim and Objective -
- Primary objective: Change in liver stiffness measured by fibroscan before and after implementation of lockdown in patients of liver disease without COVID-19 infection.
- Secondary objectives: Change in liver fat content measured by fibroscan as Controlled Attenuation Parameter (CAP) value, metabolic and laboratory parameters. (b) Methodology: OPD records of all consecutive patients of liver disease without COVID-19 infection from the Institute database from 1st January 2020 attending the liver clinic till 31st December 2020 will be reviewed. Patients with atleast two OPD visits, with one before implementation of lockdown and the other during the lockdown phase will be analysed. Patients of liver disease without atleast 2 fibroscan examination (one before lockdown and the other after lockdown implementation) will be excluded. In patients having more than one lockdown OPD visit, the one done at later time will be taken into consideration.
- Study population: Patients of liver disease attending the OPD with one visit before implementation of lockdown and the other during the lockdown phase.
- Study design: Retrospective
- Study period: NA
- Monitoring and assessment: OPD records of patients fulfilling the inclusion / exclusion criteria will be analysed for liver stiffness and CAP using Fibroscan, body weight, body mass index (BMI), complete blood count (CBC), liver function tests (LFT), kidney function test (KFT), HbA1c, fasting blood glucose, post prandial blood glucose, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides.
- Statistical Analysis: Baseline parametric data will be expressed as the proportion, mean± standard deviation and median with interquartile range. Categorical variables will be analyzed by chi squared test or Fisher exact test while the continuous variables will be analyzed using unpaired t-test or Mann-Whitney test as appropriate. Paired t-test will be used to compare the change before and after the intervention. The p value < 0.05 will be considered statistically significant.
- Adverse effects: NA
- Stopping rule of study: NA
Expected outcome of the project: Results of the study will be helpful in analyzing its impact on liver and metabolic health in liver disease patients. Importance of adequate compliance to the pharmacotherapy and healthy life style will be highlighted if result shows negative impact as the pandemic is still far from over.
- Conditions
- Liver Diseases
- Being tested
- No intervention
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
None.This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Non Cirrhotic | Non Cirrhotic Receives: Other: No intervention | |
| Compensated Cirrhotics | Compensated Cirrhotics Receives: Other: No intervention | |
| Decompensated Cirrhotics | Decompensated Cirrhotics Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver stiffness measured by fibroscan before and after implementation of lockdown in patients of liver disease without COVID-19 infection
Measured: Day 0
Secondary outcomes (8)
Change in liver fat content measured by fibroscan as Controlled Attenuation Parameter (CAP) value
Measured: Day 0
Change in weight
Measured: Day 0
Change in BMI
Measured: Day 0
Change in Liver Function tests
Measured: Day 0
Change in CBC
Measured: Day 0
Change in Fasting Blood Sugar
Measured: Day 0
Change in HbA1c
Measured: Day 0
Change in Lipid Profile
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 posted31 Aug 2021
- Study start30 Aug 2021
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies 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
- Retrospective
- Enrolment
- 230 participants (actual)
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
- NCT05028842
- Sponsor's protocol ID
- ILBS-COVID-06
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2021
- Last updated
- 22 Sep 2021
- 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 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lockdown During COVID 19 Pandemic on Liver Disease and Metabolic Parameters.
- ClinicalTrials.gov ID
- NCT05028842
- Acronym / sponsor ID
- ILBS-COVID-06
- Conditions
- Liver Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 31 Aug 2021 (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 novel corona virus disease (COVID-19), pandemic has costed lives of several hundred thousands and affected millions. Comorbidities such as metabolic syndrome components and chronic liver disease have been associated with more severe infection and increased risk of death in this pandemic. Several measures have been taking by the governments across the world. An important step taken by the Indian government was the temporary lockdown of the whole country starting from 25th March 2020 till 31st May. This was followed by relaxation in phases across the country. Lockdown and social distancing helped in controlling the pandemic, but had enormous impact on health of non-COVID patients, economics and social life. Impact of lockdown COVID-19 on metabolic control in type 2 diabetes mellitus and healthy people is studied. However, the impact on liver disease patients is not known.
Detailed description
Aim and Objective -
- Primary objective: Change in liver stiffness measured by fibroscan before and after implementation of lockdown in patients of liver disease without COVID-19 infection.
- Secondary objectives: Change in liver fat content measured by fibroscan as Controlled Attenuation Parameter (CAP) value, metabolic and laboratory parameters. (b) Methodology: OPD records of all consecutive patients of liver disease without COVID-19 infection from the Institute database from 1st January 2020 attending the liver clinic till 31st December 2020 will be reviewed. Patients with atleast two OPD visits, with one before implementation of lockdown and the other during the lockdown phase will be analysed. Patients of liver disease without atleast 2 fibroscan examination (one before lockdown and the other after lockdown implementation) will be excluded. In patients having more than one lockdown OPD visit, the one done at later time will be taken into consideration.
- Study population: Patients of liver disease attending the OPD with one visit before implementation of lockdown and the other during the lockdown phase.
- Study design: Retrospective
- Study period: NA
- Monitoring and assessment: OPD records of patients fulfilling the inclusion / exclusion criteria will be analysed for liver stiffness and CAP using Fibroscan, body weight, body mass index (BMI), complete blood count (CBC), liver function tests (LFT), kidney function test (KFT), HbA1c, fasting blood glucose, post prandial blood glucose, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides.
- Statistical Analysis: Baseline parametric data will be expressed as the proportion, mean± standard deviation and median with interquartile range. Categorical variables will be analyzed by chi squared test or Fisher exact test while the continuous variables will be analyzed using unpaired t-test or Mann-Whitney test as appropriate. Paired t-test will be used to compare the change before and after the intervention. The p value < 0.05 will be considered statistically significant.
- Adverse effects: NA
- Stopping rule of study: NA
Expected outcome of the project: Results of the study will be helpful in analyzing its impact on liver and metabolic health in liver disease patients. Importance of adequate compliance to the pharmacotherapy and healthy life style will be highlighted if result shows negative impact as the pandemic is still far from over.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non Cirrhotic | – | Other: No interventionNon Cirrhotic |
| Compensated Cirrhotics | – | Other: No interventionCompensated Cirrhotics |
| Decompensated Cirrhotics | – | Other: No interventionDecompensated Cirrhotics |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of liver disease attending the OPD with one visit before implementation of lockdown and the other during the lockdown phase
Key inclusion criteria (1 listed)
- Patients of liver disease attending the OPD.
Key exclusion criteria (3 listed)
- Patients without atleast 2 fibroscan examination (one before lockdown and the other after lockdown implementation).
- Acute self-limiting hepatitis.
- Sick patients requiring hospital admission.
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 interventionNone.This is an observational study | Other | Compensated Cirrhotics, Decompensated Cirrhotics, Non Cirrhotic |
Primary outcome
Change in liver stiffness measured by fibroscan before and after implementation of lockdown in patients of liver disease without COVID-19 infection
Time frame: Day 0
8 secondary outcomes
Change in liver fat content measured by fibroscan as Controlled Attenuation Parameter (CAP) value
Time frame: Day 0
Change in weight
Time frame: Day 0
Change in BMI
Time frame: Day 0
Change in Liver Function tests
Time frame: Day 0
Change in CBC
Time frame: Day 0
Change in Fasting Blood Sugar
Time frame: Day 0
Change in HbA1c
Time frame: Day 0
Change in Lipid Profile
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diseases, 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 22 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver stiffness measured by fibroscan before and after implementation of lockdown in patients of liver disease without COVID-19 infection (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 Sep 2021.