Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)

NCT04889053 | Recruiting DMC

• 1 other identifier: USC-4310T2DMCAC
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Vascular Calcification; Coronary Artery Calcification; Strains; Epidemiology; microRNA

Keywords

Type 2 Diabetes; Vascular calcification; Epidemiology; microRNA-32

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Anticipate completed in December 2030

• The effect of statins on the occurrence and development of CAC in patients with T2DM

  Anticipate completed in December 2030

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South China: lead

Study Sites (1)

The First Affiliated Hospital of University of South China

Hengyang, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Vascular Calcification; Sprains and Strains

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Calcinosis; Calcium Metabolism Disorders; Wounds and Injuries

Study Officials

• Liu Jianghua, PhD

  The First Affiliated Hospital of University of South China

  STUDY CHAIR

Central Study Contacts

Liu Jianghua, PhD

CONTACT

（+86）13407340909; jianghua990@126.com

Fu Chenxiao, PhD

CONTACT

(+86)13469116604; nhfyllwyh@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)