Effect of Lockdown During COVID 19 Pandemic on Liver Disease and Metabolic Parameters.
Condition: Liver Diseases
MeSH terms: COVID-19; Liver Diseases
Study type: Observational

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. 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.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): None.This is an observational study
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of liver disease attending the OPD with one visit before implementation of
        lockdown and the other during the lockdown phase