Diabetic Cardiovascular Complications: Multi-Omics Analysis

NCT ID: NCT06824233

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2028-03-01

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. What molecular changes are associated with cardiovascular complications in T2DM patients compared to healthy individuals?

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.

Participants will:

1. Provide blood samples for genomics, transcriptomics, and proteomics analysis

2. Undergo standard clinical tests such as blood pressure, echocardiogram, and ankle-brachial index measurements

3. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Age: Patients aged between 20 and 70 years.

2. Coronary Angiography: Patients who have undergone coronary angiography at the Second Xiangya Hospital of Central South University for various reasons.

3. Informed Consent: Patients who have signed the informed consent form and are willing to participate in the collection and analysis of multi-omics data.

4. Medical History and Samples: Patients who can provide complete medical history and biological samples.

Exclusion Criteria

1. Severe Diseases or Malignancy: Patients with other severe diseases or malignancies that may affect the study.

2. Cognitive or Psychiatric Disorders: Patients with cognitive or psychiatric disorders that would prevent participation or cooperation in the study.

3. Pregnancy or Lactation: Women who are pregnant or breastfeeding.

4. Short Life Expectancy: Patients with a life expectancy of less than 6 months.

5. Inability to Provide Consent: Patients unable or unwilling to provide informed consent.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Shi Tai

Role: CONTACT

taishi2017@csu.edu.cn

18711083824

Other Identifiers

LYF20240324

Identifier Type: -

Identifier Source: org_study_id