NCT04889053 Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)
| NCT ID | NCT04889053 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of South China |
| Condition | Type 2 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,400 participants in total. It began in 2021-06-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Coronary artery calcification (CAC) is a common complication of type 2 diabetes mellitus(T2DM), which can significantly increase all-cause mortality and the incidence of serious cardiovascular events, and increase the burden of the national economy. The epidemiological characteristics and the clinical progress of CAC are still not clear. Moreover, the pathogenesis of CAC has not yet been fully elucidated, and lack of specific diagnostic indicators. Arterial calcification is an active, reversible, and multifactorial biological process like bone formation. It is generally believed that early detection of calcification lesions and active targeted treatment may be the key to prevention and treatment of vascular calcification. In addition, statins are commonly used in patients with dyslipidemia and can stabilize CAC plaque. However, the timing, dosage and effect of statins are controversial. Moreover, our previous study found that the expression of miR-32 is significantly elevated in patients with CAC, and can promoting vascular calcification. Herein, this study is to conduct a prospective cohort study on T2DM patients with CAC in Hunan province through a multidisciplinary and multi-center cooperation model, the main research objectives include the following three parts: ① To identify the prevalence, incidence, and characteristics of CAC in T2DM patients in Hunan province, and to build a risk assessment model. ② To observe the effects of statins on the occurrence and development of CAC in patients with T2DM, and to provide clinical data for the improvement of medication guidelines; ③To observe the dynamic changes of serum miR-32 in the progression of CAC in patients with T2DM, and to explore its possibility as a serological diagnosis or prognostic bio-maker of CAC. The completion of this research project is expected to bring a new breakthrough in the field of early diagnosis, prognosis evaluation, and intervention treatment of patients with T2DM combined with CAC, and provide an important reference for the formulation of cardiovascular disease prevention and control strategy.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old * Type 2 diabetes is diagnosed according to WHO diagnostic criteria * Low dose prospectively triggered sequential dual-source CT coronary angiography can be performed at baseline investigation * Those subjects are able to understand the purpose and procedure of this study and sign the informed consent voluntarily Exclusion Criteria: * Those have received coronary artery stenting or coronary artery bypass grafting * Those with severe lung (respiratory failure), liver (ALT or AST 3 times normal value or bilirubin increase), renal dysfunction\[GFR \< 45ml/(min.1.73m2) or dialysis patients * Malignant tumor * Mental illness or mental retardation * Pregnant or lactating women or those with fertility planning * Concomitant diseases (hyperparathyroidism, sarcoidosis, amyloidosis) affecting calcium balance and soft tissue calcification * Contraindications of contrast agents * Based on the judgment of the researcher, the compliance is poor and the study could not be completed according to the requirements
Contact & Investigator
Liu Jianghua, PhD
STUDY CHAIR
The First Affiliated Hospital of University of South China
Frequently Asked Questions
Who can join the NCT04889053 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04889053 currently recruiting?
Yes, NCT04889053 is actively recruiting participants. Contact the research team at jianghua990@126.com for enrollment information.
Where is the NCT04889053 trial being conducted?
This trial is being conducted at Hengyang, China.
Who is sponsoring the NCT04889053 clinical trial?
NCT04889053 is sponsored by University of South China. The principal investigator is Liu Jianghua, PhD at The First Affiliated Hospital of University of South China. The trial plans to enroll 1,400 participants.
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