Effect of Lockdown During COVID 19 Pandemic on Liver Disease and Metabolic Parameters.

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

1. Patients of liver disease attending the OPD.

Exclusion Criteria:

1. Patients without atleast 2 fibroscan examination (one before lockdown and the other after lockdown implementation).
2. Acute self-limiting hepatitis.
3. Sick patients requiring hospital admission.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non Cirrhotic	Other: No intervention; None.This is an observational study
Compensated Cirrhotics	Other: No intervention; None.This is an observational study
Decompensated Cirrhotics	Other: No intervention; None.This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in liver stiffness measured by fibroscan before and after implementation of lockdown in patients of liver disease without COVID-19 infection	Day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in liver fat content measured by fibroscan as Controlled Attenuation Parameter (CAP) value	Day 0
Change in weight	Day 0
Change in BMI	Day 0
Change in Liver Function tests	Day 0
Change in CBC	Day 0
Change in Fasting Blood Sugar	Day 0
Change in HbA1c	Day 0
Change in Lipid Profile	Day 0

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): September 6, 2021
• Study Completion (Actual): September 6, 2021

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 28, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Liver Diseases; COVID-19
• Other Study ID Numbers: ILBS-COVID-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No