Heart Rate Variability and Diabetic Kidney Disease in Type 2 Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Association between HRV and renal function (eGFR and UACR)
研究概览
简要总结
Several studies have investigated an association between cardiac autonomic neuropathy (CAN) and albuminuria, glomerular filtration rate, or both, and hypothesized that CAN is involved in the pathogenesis of nephropathy. However, most of these studies had focused on Caucasians and were limited to a small number of patients with type 1 diabetes mellitus, or had used a conventional Ewing battery of tests based on dynamic cardiovascular maneuvers.Yet, there is consistent data showing that Asian diabetic populations, including the Chinese, have a higher risk of renal complications than Caucasians do.
The present study investigated an association between heart rate variability (HRV) parameters and diabetic kidney disease (DKD) in Chinese type 2 diabetes mellitus (T2DM) patients, specifically through time and frequency domain analyses of HRV and urine albumin creatinine ratio (UACR) or estimated glomerular filtration rate (eGFR).
详细描述
present study investigated an association between HRV parameters and DKD in Chinese T2DM patients, specifically through time and frequency domain analyses of HRV and UACR or eGFR
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
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
- •Clinical diagnosis of T2DM
- •Adult patients has had consecutively undergone 24-hour Holter monitoring for heart rate variability analysis
排除标准
- •Patients with acute complications of DM including diabetic ketoacidosis, hyperosmolar coma
- •Foot ulcer
- •Severe acute or chronic infection
- •Chronic liver disease
- •Dialysis or renal transplantation
- •The presence of any serious concomitant disease affecting life expectancy were not eligible for the study.
结局指标
主要结局
Association between HRV and renal function (eGFR and UACR)
时间窗: 1week
Assessment of HRV HRV measurement based on 24-hour ambulatory ECG monitoring was obtained from all patients using a 3- channel digital Holter recorder (CB-2302-A, Wuxi, Jiangsu, China). Assessment of DKD DKD was defined as the presence of albuminuria (UACR ≥ 30 mg/g,urine albumin in milligram,creatinine in gram) or eGFR \< 60 mL/min/1.73 m\^2 (creatinine concentration in umol/l,creatinine molecular weight in micromole, volume in litre;urine volume per minute in milliliter per minute; body surface area in square meter) based on SCr levels. Albuminuria was defined using UACR of a single early-morning urine measurement.For all Participants, 132 patients had albuminuria and 50 patients with eGFR \< 60 mL/min/1.73 m\^2
次要结局
- Clinical characteristics of patients(1week)
研究者
Shi wei, MM
Director
First People's Hospital of Kunming