Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus
- Conditions
- Left Ventricular DysfunctionDiabetes Mellitus
- Interventions
- Diagnostic Test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarker
- Registration Number
- NCT05484817
- Lead Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- Male or Female, aged ≥18 and ≤80 years.
- Diagnosed type 2 or type 1 diabetes
- Moderate or severe valvular heart disease, history of thoracic surgery or congenital heart disease，atrial fibrillation.
- History of coronary heart disease or stroke
- Typical symptoms of cardiovascular disease（angina pectoris or limiting dyspnoea (>NYHA II)）
- LVEF <60％
- Malignant tumor, acute infection, abnormal liver and kidney function (ALT > normal upper limit 3 times or eGFR < 60 ml/min/1.73 m2)
- Diabetic ketoacidosis
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Normal cardiac function groups Assessment of cardiovascular risk factor, endocrine hormones and related biomarker 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%. Impaired cardiac function groups Assessment of cardiovascular risk factor, endocrine hormones and related biomarker 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%.
- Primary Outcome Measures
Name Time Method Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography Day 1 Proportion of participants with GLS\>-18% in percent
- Secondary Outcome Measures
Name Time Method Glycaemic control measured by Continuous Glucose Monitoring System Day 1 - Day 14 Time in range in percent
BMI by physical assessments Day 1 BMI(body mass index) in kg/m\^2
Estradiol measured by blood test Day 1 Estradiol in pmol/l
Islet function measured by blood test Day 1 Fasting C-peptide in pmol/l
Diastolic blood pressure by physical assessments Day 1 Diastolic blood pressure in mmHg
Fasting glucose by blood test Day 1 Fasting glucose in mmol/l
Participants' personal information by questionnaire Day 1 Self-reported information(history of smoking)
Low density lipoprotein cholesterol by blood test Day 1 Low density lipoprotein cholesterol in mmol/l
Total cholesterol by blood test Day 1 Total cholesterol in mmol/l
Uric acids measured by blood test Day 1 Uric acids in umol/l
Waist by physical assessments Day 1 Waist in kg/m\^2
Systolic blood pressure by physical assessments Day 1 Systolic blood pressure in mmHg
Glycaemic control measured by blood test Day 1 HbA1c in %
Triglycerides measured by blood test Day 1 Triglycerides in mmol/l
Bone metabolism hormones measured by blood test Day 1 Osteocalcin in ng/ml
Testosterone measured by blood test Day 1 Testosterone in nmol/l
Adrenocorticotropic-hormone measured by blood test Day 1 Adrenocorticotropic-hormone in pmol/l
High density lipoprotein cholesterol by blood test Day 1 High density lipoprotein cholesterol in mmol/l
Masked hypertension diagnosed by ambulatory blood pressure monitoring Day 13-Day 14 Proportion of participants with a clinical condition in which a patient's office blood pressure (BP) level is \<140/90 mm Hg but ambulatory BP readings are in the hypertensive range in percent
Luteinizing hormone measured by blood test Day 1 Luteinizing hormone in mIU/ml
Follicle-stimulating hormone measured by blood test Day 1 Follicle-stimulating Hormone in mIU/ml
Insulin-like growth factor 1 measured by blood test Day 1 Insulin-like growth factor 1 in ng/ml
Cortisol measured by blood test Day 1 Cortisol in nmol/l
Biomarker measured by blood test Day 1 Brain natriuretic peptide in pg/ml
Trial Locations
- Locations (1)
The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China