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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Identification and validation of multi-omics biomarkers associated with metabolic syndrome and its complications | Comprehensive integration of genomic, transcriptomic, metabolomic, and microbiome datasets to identify molecular signatures predictive of metabolic syndrome progression and related complications (e.g., cardiovascular disease, chronic kidney disease, fatty liver). | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal changes in metabolomic and microbiome profiles | Evaluation of yearly changes in serum metabolite and gut microbiota composition and their correlation with metabolic parameters such as fasting glucose, triglycerides, HDL-C, and blood pressure. | Annually for 5 years |
| Association between omics-derived biomarkers and clinical outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited from outpatient clinics at Chang Gung Memorial Hospitals in Taiwan. Recruitment will occur through the Departments of Endocrinology, Cardiology, Cardiac Surgery, Nephrology, and Gastroenterology. The study population will include adults receiving routine clinical care at these sites, representing both individuals with metabolic syndrome and those without the condition who serve as healthy controls. This hospital-based community cohort reflects a diverse urban and suburban Taiwanese population, enabling comprehensive multi-omics analysis of metabolic syndrome-related diseases within a real-world clinical setting.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chi-Hsiao Yeh, MD PhD | Contact | +886-3-3281200 | 2118 | yehccl@cgmh.org.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospitals, Linkou | Recruiting | Taoyuan | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40830908 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| D050177 | Overweight |
| D002318 | Cardiovascular Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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genomics (DNA sequencing), transcriptomics (RNA sequencing), metabolomics (serum and urine metabolite profiling), and microbiomics (stool microbiota analysis).
Analysis of associations between identified omics signatures and incident cardiometabolic events (e.g., myocardial infarction, heart failure, renal impairment, fatty liver progression). |
| Up to 5 years |
| Development of an integrative risk prediction model | Construction and internal validation of a machine-learning-based model incorporating multi-omics and clinical data to predict metabolic syndrome-related complications. | 5 years |
| D009750 |
| Nutritional and Metabolic Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |