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临床试验/CTRI/2025/12/099572
CTRI/2025/12/099572尚未招募不适用

Fatty liver index VS FIBROSCAN (Vibration controlled transient elastography ) in diagnosis of Metabolic dysfunction associated fatty liver disease -Balancing accuracy and accessibility in the Indian context

Praneetha Dandamudi1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2025年12月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
57
试验地点
1

研究概览

简要总结

Metabolic Dysfunction Associated Fatty Liver Disease MAFLD, formerly known as Non-Alcoholic Fatty Liver Disease  NAFLD , is a significant global health challenge, affecting about a quarter of the worlds adult population. This high prevalence, fueled by sedentary lifestyles, low physical activity, and unhealthy diets, poses a major health and economic burden.MAFLD is defined by hepatic steatosis diagnosed via histology, imaging, or blood biomarkers alongside at least one of three criteria  overweight/obesity, type 2 diabetes mellitus (T2DM), or evidence of metabolic dysregulation (defined by at least two specific metabolic risk abnormalities like elevated waist circumference, blood pressure, triglycerides, low HDL cholesterol, prediabetes, high HOMA IR, or elevated C reactive protein). For diagnosis of hepatic steatosis while ultrasonography  is a first-line tool, it is subjective and operator-dependent. Liver biopsy, though a gold standard, is invasive, costly, carries risks, and is unsuitable for screening .These limitations highlight the critical need for simple, non-invasive diagnostic tools.Among serum based non-invasive tests , the Fatty Liver Index is considered appropriate due to its diagnostic and prognostic performance. FLI is a simple algorithm derived from readily available parameters such as Body Mass Index , waist circumference, serum triglycerides, and gamma-glutamyl transferase  levels.HeFibroScan which assesses liver stiffness (fibrosis) and hepatic steatosis (via Controlled Attenuation Parameter, CAP), is another non-invasive option. While effective, FibroScan is relatively expensive, requires specialized equipment and trained operators, and can be influenced by factors like obesity. Hence  the present study aims to determine the prevalence of MAFLD and evaluate the diagnostic performance of FLI compared to FibroScan for detecting fatty liver in adults attending a tertiary care hospital in Telangana, India.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1 Willing to give informed consent 2 Clinical suspicion of Metabolic dysfunction associated fatty liver diease based on metabolic risk factors like obesity T2Diabetes dyslipidemia 3 Able to undergo FibroScan and blood investigations.

排除标准

  • 1 Known history of significant alcohol consumption that is greater than 30g per day for men greater than 20g per day for women to differentiate from alcoholic liver disease.
  • 2 Presence of other known chronic liver diseases like viral hepatitis B or C autoimmune hepatitis primary biliary cholangitis drug-induced liver injury 3 Presence of ascites or other conditions that may interfere with accurate FibroScan measurements.
  • 4 Pregnancy.

研究者

发起方
Praneetha Dandamudi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Praneetha Dandamudi

Apollo Institute of Medical Sciences and Research

研究点 (1)

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