Clinical trial NCT06824233: Diabetic Cardiovascular Complications: Multi-Omics Analysis
Official title: Deciphering the Molecular Landscape of Diabetic Cardiovascular Complications Based on Multi-Omics Analysis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetes
Keywords: Multi-Omics Analysis
Diabetes
Cardiovascular Complications
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


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.

Primary outcomes:
measure: Incidence of Major Adverse Cardiovascular Events (MACE)
timeFrame: From enrollment to the end of treatment at 12 months and 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: