DiabetesD-CCMOANCT06824233
Diabetic Cardiovascular Complications: Multi-Omics Analysis
An observational study of Diabetes, run by Second Xiangya Hospital of Central South University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Deciphering the Molecular Landscape of Diabetic Cardiovascular Complications Based on 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:
Read more
- What molecular changes are associated with cardiovascular complications in T2DM patients compared to healthy individuals?
- 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:
- Provide blood samples for genomics, transcriptomics, and proteomics analysis
- Undergo standard clinical tests such as blood pressure, echocardiogram, and ankle-brachial index measurements
- 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
- Conditions
- Diabetes
- Keywords
- Multi-Omics Analysis, Diabetes, Cardiovascular Complications
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No Diabetes or Cardiovascular Complications Group | This group consists of individuals who do not have diabetes or cardiovascular complications. They serve as a control group for comparison with the other cohorts. Participants in this group will undergo the same clinical assessments and provide biological samples for multi-omics analysis to identify molecular differences between individuals with and without T2DM and cardiovascular issues. | |
| T2DM without Cardiovascular Complications Group | This group includes individuals diagnosed with type 2 diabetes but without any cardiovascular complications at the time of enrollment. The goal is to explore the molecular effects of T2DM on biological networks independent of cardiovascular issues. Participants will provide blood samples for genomic, transcriptomic, and proteomic analysis and undergo standard clinical tests, including echocardiograms and measurements of vascular health. | |
| T2DM with Cardiovascular Complications Group | This group consists of T2DM patients who have developed cardiovascular complications, such as coronary artery disease or heart failure. This cohort will be studied to identify how cardiovascular complications further alter molecular networks in individuals with T2DM. Blood samples will be analyzed for genomics, gene expression, and protein profiles, and participants will undergo additional clinical assessments, including vascular imaging and ankle-brachial index measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824233
- Sponsor's protocol ID
- LYF20240324
- Acronym
- D-CCMOA
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Molecular Landscape of Diabetic Cardiovascular Complications Based on Multi-Omics Analysis
- ClinicalTrials.gov ID
- NCT06824233
- Acronym / sponsor ID
- D-CCMOA / LYF20240324
- Conditions
- Diabetes
- Keywords
- Multi-Omics Analysis, Diabetes, Cardiovascular Complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What molecular changes are associated with cardiovascular complications in T2DM patients compared to healthy individuals?
- 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:
- Provide blood samples for genomics, transcriptomics, and proteomics analysis
- Undergo standard clinical tests such as blood pressure, echocardiogram, and ankle-brachial index measurements
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Diabetes or Cardiovascular Complications Group | – | –This group consists of individuals who do not have diabetes or cardiovascular complications. They serve as a control group for comparison with the other cohorts. Participants in this group will undergo the same clinical assessments and provide biological samples for multi-omics analysis to identify molecular differences between individuals with and without T2DM and cardiovascular issues. |
| T2DM without Cardiovascular Complications Group | – | –This group includes individuals diagnosed with type 2 diabetes but without any cardiovascular complications at the time of enrollment. The goal is to explore the molecular effects of T2DM on biological networks independent of cardiovascular issues. Participants will provide blood samples for genomic, transcriptomic, and proteomic analysis and undergo standard clinical tests, including echocardiograms and measurements of vascular health. |
| T2DM with Cardiovascular Complications Group | – | –This group consists of T2DM patients who have developed cardiovascular complications, such as coronary artery disease or heart failure. This cohort will be studied to identify how cardiovascular complications further alter molecular networks in individuals with T2DM. Blood samples will be analyzed for genomics, gene expression, and protein profiles, and participants will undergo additional clinical assessments, including vascular imaging and ankle-brachial index measurements. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Second Xiangya Hospital of Central South University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shi Tai (18711083824, taishi2017@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Cardiovascular Events (MACE) (time frame: From enrollment to the end of treatment at 12 months and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.