Actively Recruiting
Prospective Cohort Study of Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)
Led by University of South China · Updated on 2021-09-29
1400
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying coronary artery calcification (CAC), a common complication in people with type 2 diabetes mellitus (T2DM) that can increase the risk of serious heart problems and death. The study aims to understand how often CAC occurs, how it progresses, and the role of a molecule called miR-32 in this process. The research also looks at how statin medicines may affect the development of CAC. This observational study involves multiple hospitals in Hunan Province and follows patients over several years. The study follows hospitalized adults with T2DM for 8 years, divided into two 4-year stages at different hospitals in Hunan. Participants undergo low-dose CT scans to measure coronary artery calcification and have blood tests to detect levels of miR-32. The study groups include those without calcification and those with confirmed CAC. Researchers observe how statin use affects CAC and track changes in miR-32 as a potential early marker. Participants will have baseline assessments including CT scans and blood tests, then regular follow-ups over 8 years to monitor CAC progression and miR-32 levels. The main outcome is the rate of CAC occurrence and progression in T2DM patients. Secondary outcomes include the effects of statins on CAC and the potential of miR-32 as a diagnostic and prognostic tool. The study is expected to provide important data to improve early diagnosis, treatment, and prevention strategies for heart disease in people with T2DM.
CONDITIONS
Brief Title
Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with type 2 diabetes according to WHO criteria
- Able to undergo low-dose CT coronary angiography at baseline
- Able to understand the study purpose and provide informed consent voluntarily
You will not qualify if you...
- History of coronary artery stenting or bypass surgery
- Severe lung failure, liver dysfunction (ALT or AST 3 times normal or increased bilirubin), or kidney dysfunction (GFR < 45 ml/min/1.73m2) or on dialysis
- Malignant tumor
- Mental illness or intellectual disability
- Pregnant, breastfeeding, or planning pregnancy
- Diseases affecting calcium balance and soft tissue calcification such as hyperparathyroidism, sarcoidosis, amyloidosis
- Contraindications to contrast agents
- Poor compliance making study completion unlikely based on researcher judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo low-dose CT coronary angiography and blood tests to assess coronary artery calcification and measure serum miR-32 levels.
1 baseline visit (in-person)
Duration - 8 years
Participants are followed over 8 years to observe the development and progression of coronary artery calcification and changes in serum miR-32, with assessments divided into two 4-year stages.
Periodic follow-up visits over 8 years
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of University of South China
Hengyang, China
Actively Recruiting
Research Team
L
Liu Jianghua, PhD
F
Fu Chenxiao, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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