跳至主要内容
临床试验/NCT05466097
NCT05466097招募中不适用

Development of Polygenic Risk Score to Predict the Efficacy of Weight Loss Intervention in Children and Adolescents With Obesity

Far Eastern Memorial Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
fatty liver

研究概览

简要总结

Children with obesity are prone to suffering from metabolic diseases, which undoubtedly increases the burden of public health. Since obesity is a multiple gene disease, a comprehensive approach using polygenic risk scores (PRS), rather than individual genetic variant, may be a more appropriate method. The aim of the study was to establish a polygenic risk score model to assess differences to assess differences in weight loss treatment outcomes.

详细描述

The investigators hypothesize that obesity gene variants can predict the efficacy of weight loss intervention in obese children. The aim of the study was to establish a polygenic risk score model to assess differences to assess differences in weight loss treatment outcomes. The investigators will also analyze whether these gene variants have an effect on obesity comorbidities (hypertension, hyperlipidemia, non-alcoholic fatty liver disease, type 2 diabetes, obstructive sleep apnea, polycystic ovary syndrome, etc.). For participants with non-simple obesity, the investigators will collect their complete family history, and perform whole exome sequencing to identify possible rare disease-causing genes.

The experimental design is as follows:

Obese children and adolescent subjects will undergo a 6-month weight loss intervention program and be followed for 12-18 months. The investigators will analyze obesity and fatty liver-related genes in these adolescents using next-generation gene sequencing and/or gene chips, perform polygenic risk score analysis, and use an additive model to total the number of variant loci weighted by effect size. Whole exome gene sequencing refers to the human DNA map (hg19), and Sanger sequencing will be used to confirm the correctness of the variant site.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age <18 years old
  • Obesity definition: BMI > 95% according to the age- and gender-specific standard by National Health Institute in Taiwan
  • Willing to give written informed consent

排除标准

  • Alcohol consumption
  • Major systemic diseases, including cardiopulmonary disease, renal failure, cancer, and major psychotic disorder

结局指标

主要结局

fatty liver

时间窗: 1 month

quantification by liver ultrasound/Fibroscan

weight loss

时间窗: 6 month

changes of weight and/or BMI z score

obesity severity

时间窗: 1 month

BMI z score/BMI percentile

次要结局

  • hypertension(1 month)
  • 2 hours glucose tolerance test(1 month)
  • fasting glucose(1 month)
  • hyperlipidemia(1 month)
  • HbA1c(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验