Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus

Conditions
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Diabetes Mellitus, Left Ventricular Dysfunction

Intervention / Treatment
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* Diagnostic Test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female, aged ≥18 and ≤80 years. Diagnosed type 2 or type 1 diabetes Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal cardiac function groups<br>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%. | Diagnostic Test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarker<br>* 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<br>|
| Impaired cardiac function groups<br>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%. | Diagnostic Test: Assessment of cardiovascular risk factor, endocrine hormones and related biomarker<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography | Proportion of participants with GLS>-18% in percent | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' personal information by questionnaire | Self-reported information(history of smoking) | Day 1 | 
| BMI by physical assessments | BMI(body mass index) in kg/m^2 | Day 1 | 
| Waist by physical assessments | Waist in kg/m^2 | Day 1 | 
| Systolic blood pressure by physical assessments | Systolic blood pressure in mmHg | Day 1 | 
| Diastolic blood pressure by physical assessments | Diastolic blood pressure in mmHg | Day 1 | 
| Glycaemic control measured by blood test | HbA1c in % | Day 1 | 
| Fasting glucose by blood test | Fasting glucose in mmol/l | Day 1 | 
| Islet function measured by blood test | Fasting C-peptide in pmol/l | Day 1 | 
| Glycaemic control measured by Continuous Glucose Monitoring System | Time in range in percent | Day 1 - Day 14 | 
| High density lipoprotein cholesterol by blood test | High density lipoprotein cholesterol in mmol/l | Day 1 | 
| Low density lipoprotein cholesterol by blood test | Low density lipoprotein cholesterol in mmol/l | Day 1 | 
| Total cholesterol by blood test | Total cholesterol in mmol/l | Day 1 | 
| Triglycerides measured by blood test | Triglycerides in mmol/l | Day 1 | 
| Masked hypertension diagnosed by ambulatory blood pressure monitoring | 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 | Day 13-Day 14 | 
| Uric acids measured by blood test | Uric acids in umol/l | Day 1 | 
| Bone metabolism hormones measured by blood test | Osteocalcin in ng/ml | Day 1 | 
| Estradiol measured by blood test | Estradiol in pmol/l | Day 1 | 
| Testosterone measured by blood test | Testosterone in nmol/l | Day 1 | 
| Luteinizing hormone measured by blood test | Luteinizing hormone in mIU/ml | Day 1 | 
| Follicle-stimulating hormone measured by blood test | Follicle-stimulating Hormone in mIU/ml | Day 1 | 
| Insulin-like growth factor 1 measured by blood test | Insulin-like growth factor 1 in ng/ml | Day 1 | 
| Cortisol measured by blood test | Cortisol in nmol/l | Day 1 | 
| Adrenocorticotropic-hormone measured by blood test | Adrenocorticotropic-hormone in pmol/l | Day 1 | 
| Biomarker measured by blood test | Brain natriuretic peptide in pg/ml | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Left Ventricular Dysfunction