Clinical trial NCT05466097: Polygenic Risk Score to Predict Weight Loss Intervention in Children With Obesity
Official title: Development of Polygenic Risk Score to Predict the Efficacy of Weight Loss Intervention in Children and Adolescents With Obesity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Children
Keywords: whole exome sequencing
polygenic risk score
weight loss
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2022-07-20
Enrollment: 300
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Obese children and adolescents

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.

Eligibility criteria: 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

Primary outcomes:
measure: weight loss
timeFrame: 6 month
measure: obesity severity
timeFrame: 1 month
measure: fatty liver
timeFrame: 1 month
Secondary outcomes:
measure: hyperlipidemia
timeFrame: 1 month
measure: hypertension
timeFrame: 1 month
measure: fasting glucose
timeFrame: 1 month
measure: HbA1c
timeFrame: 1 month
measure: 2 hours glucose tolerance test
timeFrame: 1 month
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Yu-Cheng Lin,, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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