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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05466097
Enrollment
300
Registered
2022-07-20
Start date
2022-06-01
Completion date
2025-07-31
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Obesity

Keywords

whole exome sequencing, polygenic risk score, weight loss

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.

Interventions

None listed

Sponsors

Ministry of Science and Technology, Taiwan
CollaboratorOTHER_GOV
Far Eastern Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
weight loss6 monthchanges of weight and/or BMI z score
obesity severity1 monthBMI z score/BMI percentile
fatty liver1 monthquantification by liver ultrasound/Fibroscan

Secondary

MeasureTime frameDescription
HbA1c1 monthhyperglycemia
hyperlipidemia1 monthincluding triglyceride, HDL cholesterol, total cholesterol
2 hours glucose tolerance test1 monthhyperglycemia
hypertension1 monthsystolic and diastolic blood pressure
fasting glucose1 monthhyperglycemia

Countries

Taiwan

Contacts

Primary ContactYu-Cheng Lin,, M.D., Ph.D.
q92421006@ntu.edu.tw+886-89667000 Ext. 1723

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026