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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Chronic Kidney Disease; Nonalcoholic Fatty Liver Disease; Healthy; Obesity & Overweight; Metabolic Syndrome (MetS); Cardiovascular Diseases (CVD)

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT07248371

202400297A3

Details and patient eligibility

About

This study aims to validate integrative multi-omics approaches for understanding complications related to metabolic syndrome. By combining genetic, transcriptomic, metabolomic, and microbiome data from participants with and without metabolic syndrome, the research seeks to determine which biological factors predict disease progression and how these insights can inform precision prevention and treatment strategies for metabolic disorders.

Full description

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.

Enrollment: 6,266 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals (male or female) aged 20 years or older
• Willing and able to provide written informed consent to participate in the study

Exclusion criteria

• Pregnant or breastfeeding women
• Patients with end-stage renal disease receiving hemodialysis or peritoneal dialysis
• Individuals currently undergoing active cancer treatment
• Recipients of any organ transplantation
• Patients diagnosed with dementia

Trial design

6,266 participants in 1 patient group

whole cohort

Description:

Participants who meet the diagnostic criteria for metabolic syndrome, as defined by the International Diabetes Federation (IDF) and/or ATP III guidelines and those participants without metabolic syndrome who are matched to the study group by age and sex. These individuals will undergo annual biospecimen collection (blood, urine, and stool) and longitudinal clinical follow-up to identify molecular signatures associated with disease progression and metabolic complications.

Treatment:

Other: No intervention