Validating Integrative Multi-omics Approaches in Metabolic Syndrome-related Diseases

This longitudinal, multi-center study is designed to validate integrative multi-omics methodologies for predicting disease progression and complications in metabolic syndrome. Participants will be recruited from all branches of Chang Gung Memorial Hospitals. Individuals who meet the diagnostic criteria for metabolic syndrome will constitute the study group, while age- and sex-matched individuals without metabolic syndrome will serve as controls.

The study will collect peripheral blood, urine, and stool samples for comprehensive multi-omics profiling, including genomics (DNA sequencing), transcriptomics (RNA sequencing), metabolomics (serum and urine metabolite profiling), and microbiomics (stool microbiota analysis). Blood samples (10 mL) will be obtained annually for genetic and metabolomic analyses, while urine (30 mL) and stool (1 mL) samples will be used to assess metabolite and microbial signatures. These biospecimens will be linked with participants' longitudinal clinical data and laboratory test results retrieved from the Chang Gung Research Database (CGRD), providing a unified framework for integrative analysis.

Data integration will utilize advanced bioinformatics pipelines and systems biology tools to identify multi-layered molecular networks associated with disease onset and progression. Analytical methods include dimensionality reduction, clustering, and machine-learning-based feature selection to construct predictive models for metabolic complications such as cardiovascular disease, chronic kidney disease, and fatty liver disease. Identified biomarkers and pathways will be validated internally and cross-compared with pre-existing data from the "Integrated Smart Healthcare Database for Obesity."

All data will be de-identified and securely stored on institutional servers with restricted access. Each participant will be assigned a unique study code to ensure confidentiality. Data linkage between omics datasets and clinical outcomes will be performed through encrypted, privacy-preserving algorithms under the supervision of the institutional data governance committee. The study adheres to the ethical standards set by the Institutional Review Board, ensuring participant protection throughout data collection, analysis, and dissemination.

• Longitudinal changes in metabolomic and microbiome profiles [Time frame: Annually for 5 years]
• Association between omics-derived biomarkers and clinical outcomes [Time frame: Up to 5 years]
• Development of an integrative risk prediction model [Time frame: 5 years]