Diabetic Cardiovascular Complications: Multi-Omics Analysis

Deciphering the Molecular Landscape of Diabetic Cardiovascular Complications Based on Multi-Omics Analysis

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06824233

Acronym

D-CCMOA

Enrollment

300

Registered

2025-02-13

Start date

2025-03-01

Completion date

2028-03-01

Last updated

2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Multi-Omics Analysis, Diabetes, Cardiovascular Complications

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Major Adverse Cardiovascular Events (MACE)	From enrollment to the end of treatment at 12 months and 24 months	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).

Contacts

Primary ContactShi Tai

taishi2017@csu.edu.cn18711083824

Outcome results