Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School300 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Diabetes Mellitus Left Ventricular Dysfunction

Interventions

Assessment of cardiovascular risk factor, endocrine hormones and related biomarkerDIAGNOSTIC_TEST

Cardiovascular risk factors: glycated hemoglobin/C-peptide/continuous glucose monitoring/blood pressure, blood lipids, uric acid, microalbumin test, etc. Endocrin hormones: bone metabolism, sex hormones, adrenal and pituitary hormones, and related biomarkers

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

RECRUITING

Outcomes

Primary Outcomes

Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography

Proportion of participants with GLS\>-18% in percent

Time frame: Day 1

Secondary Outcomes

Participants' personal information by questionnaire

Self-reported information(history of smoking)

Time frame: Day 1

BMI by physical assessments

BMI(body mass index) in kg/m\^2

Time frame: Day 1

Waist by physical assessments

Waist in kg/m\^2

Time frame: Day 1

Systolic blood pressure by physical assessments

Systolic blood pressure in mmHg

Time frame: Day 1

Diastolic blood pressure by physical assessments

Diastolic blood pressure in mmHg

Time frame: Day 1

Glycaemic control measured by blood test

HbA1c in %

Time frame: Day 1

Fasting glucose by blood test

Fasting glucose in mmol/l

Time frame: Day 1

Islet function measured by blood test

Fasting C-peptide in pmol/l

Time frame: Day 1

Central Contacts

Dalong Zhu, MD,PhD

CONTACT

86-025-83106666 zhudalong@nju.edu.cn

Ran Meng, MD,PhD

CONTACT

86-025-83106666 179622242@qq.com

Data from ClinicalTrials.gov

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