Early Assessment of Impaired Cardiac Function in Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, aged ≥18 and ≤80 years.
- •Diagnosed type 2 or type 1 diabetes
排除标准
- •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)）
- •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
结局指标
主要结局
Prevalence of impaired cardiac function in type 2 diabetes diagnosed by echocardiography
时间窗: Day 1
Proportion of participants with GLS\>-18% in percent
次要结局
- Islet function measured by blood test(Day 1)
- Diastolic blood pressure by physical assessments(Day 1)
- Fasting glucose by blood test(Day 1)
- Participants' personal information by questionnaire(Day 1)
- Glycaemic control measured by Continuous Glucose Monitoring System(Day 1 - Day 14)
- Low density lipoprotein cholesterol by blood test(Day 1)
- Total cholesterol by blood test(Day 1)
- Uric acids measured by blood test(Day 1)
- Waist by physical assessments(Day 1)
- Systolic blood pressure by physical assessments(Day 1)
- Glycaemic control measured by blood test(Day 1)
- BMI by physical assessments(Day 1)
- Triglycerides measured by blood test(Day 1)
- Bone metabolism hormones measured by blood test(Day 1)
- Estradiol measured by blood test(Day 1)
- Testosterone measured by blood test(Day 1)
- Adrenocorticotropic-hormone measured by blood test(Day 1)
- High density lipoprotein cholesterol by blood test(Day 1)
- Masked hypertension diagnosed by ambulatory blood pressure monitoring(Day 13-Day 14)
- Luteinizing hormone measured by blood test(Day 1)
- Follicle-stimulating hormone measured by blood test(Day 1)
- Insulin-like growth factor 1 measured by blood test(Day 1)
- Cortisol measured by blood test(Day 1)
- Biomarker measured by blood test(Day 1)
研究者
Dalong Zhu
Chief Physician , Principal Investigator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School