Diabetic Cardiovascular Complications: Multi-Omics Analysis
ConditionDiabetes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-70
SponsorSecond Xiangya Hospital of Central South University
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 3 trial groupsGroup A: No Diabetes or Cardiovascular Complications Group
Group B: T2DM without Cardiovascular Complications Group
Group C: T2DM with Cardiovascular Complications Group
Trial outcomes
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).
Time frame
From enrollment to the end of treatment at 12 months and 24 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: