Type 2 DiabetesNCT04889053
Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)
An observational study of Type 2 Diabetes and Vascular Calcification, run by University of South China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Vascular Calcification, Coronary Artery Calcification
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 Dec 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of University of South China
Hengyang
Liu Jianghua, PhD
About this study
Official title: Prospective Cohort Study of Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)
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.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes, Vascular Calcification, Coronary Artery Calcification, Strains, Epidemiology, microRNA
- Keywords
- Type 2 Diabetes, Vascular calcification, Epidemiology, microRNA-32
- Medical subject headings
- Diabetes Mellitus, Type 2, Vascular Calcification, Sprains and Strains
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 |
|---|---|---|
| D2M, Vascular calcification-free | Meet the inclusion criteria, there is no calcification detected by low dose prospectively triggered sequential dual-source CT coronary angiography | |
| D2M with vascular calcification | Meet the inclusion criteria, and have coronary artery calcification ( be confirmed by low dose prospectively triggered sequential dual-source CT coronary angiography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Anticipate completed in December 2026
Secondary outcomes (2)
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.
Measured: 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
Measured: Anticipate completed in December 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liu Jianghua, PhD, Study chair, The First Affiliated Hospital of University of South China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889053
- Sponsor's protocol ID
- USC-4310T2DMCAC
- Status last verified
- Sep 2021
- First submitted
- 11 May 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)
- ClinicalTrials.gov ID
- NCT04889053
- Acronym / sponsor ID
- USC-4310T2DMCAC
- Conditions
- Type 2 Diabetes, Vascular Calcification, Coronary Artery Calcification, Strains, Epidemiology, microRNA
- Keywords
- Type 2 Diabetes, Vascular calcification, Epidemiology, microRNA-32
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- University of South ChinaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 May 2021 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D2M, Vascular calcification-free | – | –Meet the inclusion criteria, there is no calcification detected by low dose prospectively triggered sequential dual-source CT coronary angiography |
| D2M with vascular calcification | – | –Meet the inclusion criteria, and have coronary artery calcification ( be confirmed by low dose prospectively triggered sequential dual-source CT coronary angiography) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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
The prevalence and incidence rate of CAC in T2DM
Time frame: Anticipate completed in December 2026
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.
2 secondary outcomes
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
Time frame: Anticipate completed in December 2030
The effect of statins on the occurrence and development of CAC in patients with T2DM
Time frame: Anticipate completed in December 2030
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 29 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Liu Jianghua, PhD study chair
The First Affiliated Hospital of University of South China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes and Vascular Calcification, run by University of South China at 1 site in China.
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 8 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: looking for participants now, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Liu Jianghua, PhD (（+86）13407340909, jianghua990@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence and incidence rate of CAC in T2DM (time frame: Anticipate completed in December 2026). 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 29 Sep 2021.