An observational study in Type 2 Diabetes, Vascular Calcification and Coronary Artery Calcification, sponsored by University of South China. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-29.
Sponsored by University of South China · Observational
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.
The prospective cohort study of type 2 diabetes mellitus(T2DM) with coronary artery calcification (CAC) is a multi-center, observational clinical study. The study included a baseline survey and 8-year follow-up survey of hospitalized patients with T2DM in seven third-class hospital in Hunan Province (the follow-up is divided into two stages, the first stage is the first 4 years, and the second stage is the last 4 years). The first phase is conducted in three affiliated hospitals of University of South China in Hengyang City, Hunan Province, and the second phase is conducted in four representative Grade-A hospitals according to the geographical location of Hunan Province. The sample size of each center is set to be at least 200 cases, and that of a single center is at most 500 cases. The diagnosis of T2DM is made according to the criteria of the WHO in 1999, and the hyperglycemia caused by type 1 diabetes, gestational diabetes, special type diabetes and other factors are excluded. The volume and density of coronary artery calcification are evaluated by low dose prospectively triggered sequential dual-source CT coronary angiography. The coronary artery calcification score (CACS) is calculated by CAS coring software. MiR-32 is detected by PCR. All in all, this clinical trial is aiming to establishing a prospective long-term follow-up cohort of patients with T2DM complicated with CAC in Hunan Province, to observing the effect of statins on the occurrence and development of CAC in patients with T2DM, and to exploring the dynamic changes of serum miR-32 in this process to determine whether it can be used as an early diagnosis and prognostic marker of vascular calcification.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →This is the only study on the registry with University of South China as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The prospective cohort study of type 2 diabetes mellitus with coronary artery calcification is a multicenter, observational clinical study for patients with type 2 diabetes mellitus. The study included a baseline survey and an 8-year follow-up survey of hospitalized patients with type 2 diabetes mellitus in seven third-class hospital in Hunan Province. The first phase is conducted in three affiliated hospitals of University of South China in Hengyang City, Hunan Province, and the second phase is conducted in four representative Grade-A hospitals according to the geographical location of Hunan Province. The sample size of each center is set to be at least 200 cases, and that of a single-center is at most 500 cases.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Meet the inclusion criteria, there is no calcification detected by low dose prospectively triggered sequential dual-source CT coronary angiography
Meet the inclusion criteria, and have coronary artery calcification ( be confirmed by low dose prospectively triggered sequential dual-source CT coronary angiography)
The prevalence and incidence rate of CAC in T2DM
Based on the baseline data of cohort study, the prevalence of CAC in hospitalized patients with T2DM in Hunan Province is determined by descriptive analysis, and the characteristics of different gender, age group, degree of obesity and duration of diabetes mellitus are explored. Based on prospective cohort data, the incidence rate and characteristics of CAC in T2DM inpatients in Hunan province of China are defined.
Time frame: Anticipate completed in December 2026
The dynamic changes of miR-32 in the occurrence and development of CAC in patients with T2DM, and to clarify the value of miR-32 as a risk marker for early diagnosis and prognosis of CAC
Based on the blood sample of patients in this cohort study, the serum miR-32, OPG and alkaline phosphatase(ALP) are detected by RT-PCR, ELISA and colorimetry at baseline. The low dose prospectively triggered sequential dual-source CT coronary angiography image results are taken as the gold standard, The diagnostic value, sensitivity and specificity of the three indicators in the occurrence of CAC in type 2 diabetes mellitus are analyzed.
Time frame: Anticipate completed in December 2030
The effect of statins on the occurrence and development of CAC in patients with T2DM
Based on the observational data of prospective cohort study, the effects of different types, doses and application timing of statins on the progression of CAC and cardiovascular events are studied by analysis of covariance or chi square test
Time frame: Anticipate completed in December 2030
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.