Validating Integrative Multi-omics Approaches in Metabolic Syndrome-related Diseases
NCT ID: NCT07248371
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6266 participants
OBSERVATIONAL
2025-06-09
2035-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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whole cohort
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.
No intervention
no intervention
Interventions
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No intervention
no intervention
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide written informed consent to participate in the study
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Locations
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Chang Gung Memorial Hospitals, Linkou
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Hsu PW, Yeh CH, Lo CJ, Tsai TH, Chan YH, Chou YJ, Yang NI, Cheng ML, Sheu WH, Lai CC, Sytwu HK, Tsai TF. Trans-omics analyses identify the biochemical network of LPCAT1 associated with coronary artery disease. Biomark Res. 2025 Aug 20;13(1):107. doi: 10.1186/s40364-025-00821-y.
Related Links
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Other Identifiers
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202400297A3
Identifier Type: -
Identifier Source: org_study_id
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