Diabetic Cardiovascular Complications: Multi-Omics Analysis

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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Incidence of Major Adverse Cardiovascular Events (MACE)

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Shi Tai

CONTACT

[email protected]

18711083824

Sponsors and collaborators

Lead sponsor

Second Xiangya Hospital of Central South University

Other

Registry information

Official study title

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

Acronym: D-CCMOA

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Feb 13, 2025
Registry last updated: Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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