跳至主要内容
临床试验/CTRI/2024/06/068925
CTRI/2024/06/068925尚未招募不适用

Comparison of Ultrasound Guided Attenuation Parameter and MRI Proton Density Fat Fraction in the assessment of hepatic steatosis in Indian adolescents: A pilot study

St. Johns Medical College Research Society1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年6月25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
46
试验地点
1
主要终点
To compare hepatic fat in Indian adolescents as assessed using UGAP with MRI PDFF methods

研究概览

简要总结

Objectives: To compare hepatic fat in Indian adolescents as assessed using UGAP with MRI PDFF methods

Methodology: Details on SES, habitual dietary assessment, physical activity questionnaire, anthropometric measurements and a detailed clinical examination will be conducted for every subject. Biochemical analysis will be carried out in 4 ml of fasting venous blood samples collected at recruitment. Hemoglobin estimation, fasting blood sugar, serum HDL-cholesterol, serum triglycerides, serum aspartate aminotransferase and serum alanine aminotransferase will be estimated. All subjects will undergo total body composition measurement by the Dual energy X Ray absorptiometry DEXA machine. Hepatic fat quantification will be done in each subject using MRI PDFF and UGAP methods one after another. For MRI PDFF, a 3.0 T system GE Signa Architect will be used and a 3D volumetric, greater than 16sec breath hold sequence for fat quantification will be performed. UGAP will be performed for each subject by a single radiologist in the radiology suite using LOGIQ E10 ultrasound system GE Healthcare

Need of the study: Of concern in India, is that in national child surveys, an increase in biomarkers of metabolic obesity is occurring even in those children who apparently appear anthropometrically undernourished. On-invasive screening modality which can pick up early signs of ill-health or metabolic dysregulation in children is the need of the hour. This will help in instituting lifestyle changes, prevent tracking of disease into adulthood and reduce the burden of chronic disease. Though, MRI PDFF is accurate in detecting and quantifying hepatic fat, it is limited by accessibility and is inapplicable as a screening technique. UGAP can be performed in all ages, is portable and cost effective, but requires validation in Indian children for diagnostic accuracy with MRI PDFF.

研究设计

研究类型
Observational

入排标准

年龄范围
10.00 Year(s) 至 17.00 Year(s)(—)
性别
All

入选标准

  • No history of liver disease (Hepatitis, tumours, surgery, or recent use of hepatotoxic drugs) Parents and children (wherever applicable) willing to provide written consent for the study.

排除标准

  • 1.Motion artefacts that degrade MRI image quality.
  • 2.General contraindications for MRI (Cardiac pacemakers, Cochlear and metallic implants, metallic foreign bodies) 3.Claustrophobia.

结局指标

主要结局

To compare hepatic fat in Indian adolescents as assessed using UGAP with MRI PDFF methods

时间窗: Single study day. (One point assessment at baseline)

次要结局

  • To characterise the risk factors for the development of hepatic fat in Indian adolescents based on history, nutritional assessment & biochemical investigations(To correlate the percentage of hepatic fat / grades of steatosis as assessed through UGAP with MRI PDFF measurements with biochemical parameters)

研究者

发起方
St. Johns Medical College Research Society
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Shalini Gajanan Hegde

St. John’s Medical College

研究点 (1)

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