Diabetic Cardiovascular Complications: Multi-Omics Analysis

NCT06824233 | Not Yet Recruiting

• 1 other identifier: LYF20240324
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn about the molecular mechanisms underlying cardiovascular complications in individuals with type 2 diabetes (T2DM) and how they differ from healthy individuals. The study will also identify biomarkers and potential therapeutic targets for better managing diabetes-related heart disease. The main questions it aims to answer are:

1. 1.What molecular changes are associated with cardiovascular complications in T2DM patients compared to healthy individuals?
2. 2.How do genetic, gene expression, and protein profiles differ between T2DM patients with and without cardiovascular complications? Researchers will compare the molecular profiles of three groups: healthy controls, individuals with T2DM but no cardiovascular complications, and those with T2DM and cardiovascular complications.
3. 3.Provide blood samples for genomics, transcriptomics, and proteomics analysis
4. 4.Undergo standard clinical tests such as blood pressure, echocardiogram, and ankle-brachial index measurements
5. 5.Be followed for 12 to 24 months to track the development of cardiovascular events Participate in follow-up phone interviews to record major cardiovascular events like heart attacks or strokes

Conditions

Diabetes

Keywords

Multi-Omics Analysis; Diabetes; Cardiovascular Complications

Outcome Measures

Primary Outcomes (1)

• Incidence of Major Adverse Cardiovascular Events (MACE)

  Description: To assess the occurrence of major adverse cardiovascular events (MACE), including myocardial infarction, stroke, or heart failure, over the 2-year follow-up period. Time Frame: 12 months and 24 months follow-up. Measurement Method: Clinical assessments through medical records, including hospitalizations, laboratory data, echocardiograms, and imaging techniques (e.g., vascular imaging, ABI, carotid ultrasound).

  From enrollment to the end of treatment at 12 months and 24 months

Study Arms (3)

No Diabetes or Cardiovascular Complications Group

This group consists of individuals who do not have diabetes or cardiovascular complications. They serve as a control group for comparison with the other cohorts. Participants in this group will undergo the same clinical assessments and provide biological samples for multi-omics analysis to identify molecular differences between individuals with and without T2DM and cardiovascular issues.

T2DM without Cardiovascular Complications Group

This group includes individuals diagnosed with type 2 diabetes but without any cardiovascular complications at the time of enrollment. The goal is to explore the molecular effects of T2DM on biological networks independent of cardiovascular issues. Participants will provide blood samples for genomic, transcriptomic, and proteomic analysis and undergo standard clinical tests, including echocardiograms and measurements of vascular health.

T2DM with Cardiovascular Complications Group

This group consists of T2DM patients who have developed cardiovascular complications, such as coronary artery disease or heart failure. This cohort will be studied to identify how cardiovascular complications further alter molecular networks in individuals with T2DM. Blood samples will be analyzed for genomics, gene expression, and protein profiles, and participants will undergo additional clinical assessments, including vascular imaging and ankle-brachial index measurements.

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients who have undergone coronary angiography at the Second Xiangya Hospital of Central South University for various reasons. The study will involve individuals aged between 20 and 70 years who meet the inclusion criteria, including providing informed consent and the ability to supply complete medical history and biological samples. The population will encompass individuals with varying levels of cardiovascular health, including those with and without cardiovascular complications, to enable comprehensive multi-omics analysis and long-term cardiovascular event tracking.

You may qualify if:

• Age: Patients aged between 20 and 70 years.
• Coronary Angiography: Patients who have undergone coronary angiography at the Second Xiangya Hospital of Central South University for various reasons.
• Informed Consent: Patients who have signed the informed consent form and are willing to participate in the collection and analysis of multi-omics data.
• Medical History and Samples: Patients who can provide complete medical history and biological samples.

You may not qualify if:

• Severe Diseases or Malignancy: Patients with other severe diseases or malignancies that may affect the study.
• Cognitive or Psychiatric Disorders: Patients with cognitive or psychiatric disorders that would prevent participation or cooperation in the study.
• Pregnancy or Lactation: Women who are pregnant or breastfeeding.
• Short Life Expectancy: Patients with a life expectancy of less than 6 months.
• Inability to Provide Consent: Patients unable or unwilling to provide informed consent.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Biospecimen

Retention: SAMPLES WITH DNA

The study will collect several types of biological samples from participants, but all samples will be destroyed immediately after testing. These include: Blood Samples (5 mL per participant): Blood samples will be collected for genomics, transcriptomics, and proteomics analysis. The blood will be processed to isolate plasma, serum, and peripheral blood mononuclear cells (PBMCs) for the following purposes: 1. Genomic analysis 2. Transcriptomic analysis 3. Proteomic analysis

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Shi Tai

CONTACT

18711083824; taishi2017@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: To access the IPD and supporting information, interested parties should contact the principal investigator.