Menu
Not yet recruiting NCT06824233

Diabetic Cardiovascular Complications: Multi-Omics Analysis

Observational Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Diabetes. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Primary outcome measures

  • Incidence of Major Adverse Cardiovascular Events (MACE) [Time frame: From enrollment to the end of treatment at 12 months and 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06824233 · LYF20240324

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗