Effect of Lockdown During COVID 19 Pandemic on Liver Disease and Metabolic Parameters.
1 other identifier
observational
230
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2021
CompletedStudy Start
First participant enrolled
August 30, 2021
CompletedFirst Posted
Study publicly available on registry
August 31, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2021
CompletedSeptember 22, 2021
August 1, 2021
7 days
August 25, 2021
September 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (3)
Non Cirrhotic
Non Cirrhotic
Compensated Cirrhotics
Compensated Cirrhotics
Decompensated Cirrhotics
Decompensated Cirrhotics
Interventions
None.This is an observational study
Eligibility Criteria
Patients of liver disease attending the OPD with one visit before implementation of lockdown and the other during the lockdown phase
You may qualify if:
- Patients of liver disease attending the OPD.
You may not qualify if:
- Patients without atleast 2 fibroscan examination (one before lockdown and the other after lockdown implementation).
- Acute self-limiting hepatitis.
- Sick patients requiring hospital admission.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2021
First Posted
August 31, 2021
Study Start
August 30, 2021
Primary Completion
September 6, 2021
Study Completion
September 6, 2021
Last Updated
September 22, 2021
Record last verified: 2021-08