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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorChang Gung Memorial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals (male or female) aged 20 years or older

Willing and able to provide written informed consent to participate in the study

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    no intervention

Treatment groups

6,266 Participants
are divided into 1 treatment group
Group A: whole cohort1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
5 years

Secondary outcomes

1

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.

Time frame
Annually for 5 years
2

Association between omics-derived biomarkers and clinical outcomes

Analysis of associations between identified omics signatures and incident cardiometabolic events (e.g., myocardial infarction, heart failure, renal impairment, fatty liver progression).

Time frame
Up to 5 years
3

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.

Time frame
5 years

Other outcomes

Sponsors and contacts

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