A study to evaluate the prevalence and distribution of steatotic and fibrotic liver disease across India
| ISRCTN | ISRCTN18116615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18116615 |
| Secondary identifying numbers | Z2400301 |
- Submission date
- 24/07/2024
- Registration date
- 06/08/2024
- Last edited
- 19/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Non-alcoholic fatty liver disease (NAFLD) is a common liver condition where fat builds up in the liver. This can lead to more serious liver problems like non-alcoholic steatohepatitis (NASH), cirrhosis, and liver failure. In India, the rates of NAFLD are increasing due to rising obesity, type 2 diabetes, and metabolic syndrome. However, there's a lack of comprehensive data on how widespread NAFLD is across different regions of India. This study aims to fill that gap by using a non-invasive test called vibration-controlled transient elastography (VCTE) to measure liver fat and stiffness, helping us understand the prevalence and distribution of liver disease across the country.
Who can participate?
Adults over the age of 18 years who have consented to undergo the VCTE test for assessing liver health can participate in this study. Both men and women are eligible.
What does the study involve?
The study involves collecting data from patients who have already undergone the VCTE test between January 2023 and April 2024.
What are the possible benefits and risks of participating?
Participants will not experience direct benefits or risks from this study as it involves analyzing previously collected data. However, the findings could benefit the broader public by providing valuable insights into the prevalence of liver disease in India, potentially leading to better-targeted public health interventions and policies.
When is the study starting and how long is it expected to run for?
May 2023 to April 2024
Who is funding the study?
Zydus Healthcare Ltd (India)
Who is the main contact?
Dr Kunal Jhaveri, Kunal.Jhaveri@zyduslife.com
Contact information
Principal Investigator
Ananda Medicare
Delhi
110085
India
| Phone | +91 (0)11 45058857 |
|---|---|
| anandamedicare@gmail.com |
Public, Scientific
Digicare Healthcare Solutions Private Limited
Ahmedabad
380058
India
| Phone | +91 (0)8290799906 |
|---|---|
| patientsafety@tatvacare.in |
Study information
| Study design | Retrospective cross-sectional observational multi-centric study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Care home, Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A retrospective cross-sectional observational multi-centric study to evaluate the prevalence and distribution of steatotic and fibrotic liver disease across India via vibration-controlled transient elastography parameters |
| Study objectives | There is a significant prevalence of steatotic and fibrotic liver disease across different regions of India, which can be accurately assessed using vibration-controlled transient elastography (VCTE) parameters controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) |
| Ethics approval(s) |
Approved 22/07/2024, Royal Pune Independent Ethics Committee (Office No. 13, Srv. No.81/A, Anupam Arcade, Opposite Snake Park, Katraj, Pune-Maharashtra, 411046, India; +91 (0)72468233; royalpuneiec@gmail.com), ref: RPIEC410724 |
| Health condition(s) or problem(s) studied | Non-alcoholic fatty liver disease (NAFLD) |
| Intervention | The study involves collecting data from patients who have already undergone the VCTE test between January 2023 and April 2024. |
| Intervention type | Other |
| Primary outcome measure | Prevalence of steatotic and fibrotic liver disease measured using Vibration Controlled Transient Elastography (VCTE) parameters, including Controlled Attenuation Parameter (CAP) and Liver Stiffness Measurement (LSM). Data were collected retrospectively from patients who underwent VCTE between January 2023 and April 2024. |
| Secondary outcome measures | Analysis of age-wise and gender-wise distribution conducted using deidentified patient data. This data was retrospectively collected from January 2023 to April 2024. |
| Overall study start date | 22/05/2023 |
| Completion date | 30/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 15520 |
| Total final enrolment | 13750 |
| Key inclusion criteria | 1. Age >18 years 2. Patients who have given consent for the FIBROSCAN™ (VCTE) test |
| Key exclusion criteria | 1. Pregnant or breastfeeding women 2. Individuals with alcohol consumption of more than 30 g and 20 g per day |
| Date of first enrolment | 01/01/2023 |
| Date of final enrolment | 30/04/2024 |
Locations
Countries of recruitment
- India
Study participating centres
Gurudwara Sant Samagam, CSC-2, Adjoining DDA Market, Sector-9, Rohini, Delhi
New Delhi
110085
India
Ahmedabad
380050
India
Ahmedabad
380007
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Ahmedabad
380015
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Ahmedabad
380015
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Rajkot
360002
India
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402107
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700133
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641020
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620001
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282002
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125011
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302007
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302006
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135003
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134109
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135003
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180004
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400008
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411044
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411030
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380013
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250110
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Sponsor information
Industry
Zydus Tower CTS No- 460/6 of Village Pahadi
Off I. B. Patel Road
Goregaon (East)
Mumbai
400063
India
| Phone | +91 (0)9601649741 |
|---|---|
| Kunal.Jhaveri@zyduslife.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The dataset generated during and/or analysed during the current study are not expected to be made available due to the retrospective nature of the study and deidentified data is being used solely for the purpose of understanding the prevalence and distribution of liver disease in India. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 17/05/2025 | 19/05/2025 | Yes | No |
Editorial Notes
19/05/2025: Publication reference added.
07/10/2024: The following changes were made:
1. Study participating centres removed: Sarthak Health Clinic, Manav Clinic, Om Complete Diabetes Clinic, Apollo Hospital International Limited Ahmedabad, Pratham Endocrine & Diabetes Centre, Durgapur City Hospital & Clinic, Aarush Clinic, Omnibus Healthcare, Srajan Hospital, Mata Gujri Medical Centre, Door to Care, Mohan Heart Care Clinic, MKS Endoconsult, Dr. Pramod Kr. Pattanaik, Dr. S P Kumar, Dr Pawan Kumar Goyal Clinic, and Dr S Tripathi.
2. Study participating centres added: Life Line Sugar Clinic, AP Hospital - Diabetes Speciality Center, Prabhu Diabetes & Multi-Specialty Center, Care Hospital, Holy Help Hospital, Central Railway Hospital, ESIC Model Hospital, Indra Hospital, Heart Line, Multi Speciality Hospital, Kamboj Heart centre & Multi Speciality Hospital, Jammu Diabetes & Thyroid Care Center, AMS NEOLIFE Superspeciality Clinic, Dr. Anand Kalaskar Clinic, Dr A R Kench, Dr. Dharmendra Panchal, and Dr Ashutosh Jain.
24/07/2024: Study's existence confirmed by the Royal Pune Independent Ethics Committee.
