Polygenic Risk Score to Predict Weight Loss Intervention in Children With Obesity

Recruiting

• Conditions: Obesity; Children

• Registration Number: NCT05466097
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
fatty liver	1 month	quantification by liver ultrasound/Fibroscan
weight loss	6 month	changes of weight and/or BMI z score
obesity severity	1 month	BMI z score/BMI percentile

Secondary Outcome Measures

Name	Time	Method
hypertension	1 month	systolic and diastolic blood pressure
fasting glucose	1 month	hyperglycemia
2 hours glucose tolerance test	1 month	hyperglycemia
hyperlipidemia	1 month	including triglyceride, HDL cholesterol, total cholesterol
HbA1c	1 month	hyperglycemia

Trial Locations

Locations (1)

Far Eastern Memorial Hospital; 🇨🇳 New Taipei City, Taiwan