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