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临床试验/CTRI/2025/03/082035
CTRI/2025/03/082035尚未招募不适用

Markers of metabolic and oxidative stress in children with Down syndrome

Department Of Pediatrics Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年3月20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
86
试验地点
1
主要终点
Means levels of Leptin and Adiponectin in children with DOWN syndrome

研究概览

简要总结

This study is a observational case control study to assess the metabolic and oxidative stress in children with Down Syndrome in comparison with age and gender matched healthy control population by estimating the mean levels of Leptin , Adiponectin and Superoxide Dismutase levels .Also the level of hepatic steatosis as measured by shear wave elastography . The study will be conducted in OPD’s and IPD’s of Department of Pediatrics in Maulana Azad Medical College and Associated Lok Nayak Hospital , New Delhi.

The objective of the study is to compare levels of Leptin , Adiponectin , SOD in children with Down syndrome with their healthy control siblings and to assess liver steatosis by shear wave elastography on ultrasonography . The hypothesis of our study is that children with Down Syndrome are at risk of high levels of oxidative stress which is linked to atheroscelerosis development , neurodegeneration , cell  aging and cancer .

研究设计

研究类型
Observational

入排标准

年龄范围
6.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children diagnosed with Down syndrome in this age group Control.
  • Children with no medical illness.
  • age and gender matched.

排除标准

  • Children with mosaic trisomy on karyotype. Control.
  • Childen with obesity and pre existing diabetes mellitus.

结局指标

主要结局

Means levels of Leptin and Adiponectin in children with DOWN syndrome

时间窗: Means levels of Leptin and Adiponectin in children with DOWN syndrome at first visit or day 1 | Mean levels of Superoxide dismutase in children with Down syndrome on first visit Association between the levels of these markers including lipid profile with BMI and hepatic steatosis as estimated with shear wave elastogaphy on first visit .

Mean levels of Superoxide dismutase in children with Down syndrome.

时间窗: Means levels of Leptin and Adiponectin in children with DOWN syndrome at first visit or day 1 | Mean levels of Superoxide dismutase in children with Down syndrome on first visit Association between the levels of these markers including lipid profile with BMI and hepatic steatosis as estimated with shear wave elastogaphy on first visit .

Association between the levels of these markers including lipid profile with BMI and hepatic steatosis as estimated with shear wave elastogaphy.

时间窗: Means levels of Leptin and Adiponectin in children with DOWN syndrome at first visit or day 1 | Mean levels of Superoxide dismutase in children with Down syndrome on first visit Association between the levels of these markers including lipid profile with BMI and hepatic steatosis as estimated with shear wave elastogaphy on first visit .

次要结局

  • Means levels of Leptin & Adiponectin in children with DOWN syndrome(Mean levels of Superoxide dismutase in children with Down syndrome.)

研究者

发起方
Department Of Pediatrics Maulana Azad Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Arshida Husain

Maulana Azad Medical College

研究点 (1)

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