Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus

Nanjing University

Status: Enrolling

Conditions: Diabetes Mellitus; Left Ventricular Dysfunction

Treatments: Diagnostic Test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarker

Study type: Observational

Funder types: Other

Identifiers

NCT05484817

DCM2022

Details and patient eligibility

About

This is a single-center, prospective, observational study to explore the clinical features and risk factors of impaired cardiac function detected by two-dimensional speckle tracking echocardiography in patients with diabetes mellitus. The risk factors include traditional cardiovascular risk factors, bone metabolism hormones, sex hormones, adrenal and pituitary hormones, and novel serum biomarkers.

Full description

Cardiovascular complications are a leading cause of death in patients with diabetes mellitus. However, early cardiovascular disease screening presents several challenges, particularly for those who have no cardiovascular symptoms. Novel imaging techniques, such as tissue Doppler imaging and speckle tracking echocardiography, allow for the more frequent detection of early subclinical left ventricular systolic dysfunction in asymptomatic patients with diabetes. Based on speckle tracking echocardiography and other techniques, this study evaluated cardiovascular function in diabetic subjects to achieve the following objectives:

A) Investigate the clinical characteristics of diabetic patients with early cardiovascular function impairment. B) Investigate the role of traditional cardiovascular risk factors, bone metabolism hormones, sex hormones, adrenal and pituitary hormones in diabetic patients with early cardiovascular function impairment. C) Explore novel biomarkers of early cardiovascular dysfunction in diabetic patients.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female, aged ≥18 and ≤80 years.
2. Diagnosed type 2 or type 1 diabetes

Exclusion criteria

1. Moderate or severe valvular heart disease, history of thoracic surgery or congenital heart disease，atrial fibrillation.
2. History of coronary heart disease or stroke
3. Typical symptoms of cardiovascular disease（angina pectoris or limiting dyspnoea (>NYHA II)）
4. LVEF <60％
5. Malignant tumor, acute infection, abnormal liver and kidney function (ALT > normal upper limit 3 times or eGFR < 60 ml/min/1.73 m2)
6. Diabetic ketoacidosis
7. Pregnancy

Trial design

300 participants in 2 patient groups

Normal cardiac function groups

Description:

Patients admitted to the hospital or recruited from the community with diabetes mellitus are screened for cardiovascular diseases by echocardiography. Global longitudinal strain (GLS) is measured by speckle tracking echocardiography. The 2015 American Society of Echocardiography guidelines recommended a mean of -20% for GLS in healthy subjects, while the upper normal limit is -18%. Therefore, the normal cardiac function groups are defined as GLS \< -18%.

Treatment:

Diagnostic Test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarker

Impaired cardiac function groups

Description:

Patients admitted to the hospital or recruited from the community with diabetes mellitus are screened for cardiovascular diseases by echocardiography. Global longitudinal strain (GLS) is measured by speckle tracking echocardiography. The 2015 American Society of Echocardiography guidelines recommended a mean of -20% for GLS in healthy subjects, while the upper normal limit is -18%. Therefore, the impaired cardiac function groups are defined as GLS ≥ -18%.

Treatment:

Diagnostic Test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarker