Heart Rate Variability and Diabetic Kidney Disease in Type 2 Diabetes Mellitus Patients
- Conditions
- Type2 Diabetes Mellitus
- Interventions
- Other: Clinical examination and laboratory measurements
- Registration Number
- NCT02996539
- Lead Sponsor
- Shi wei, MM
- Brief Summary
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).
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 392
- Clinical diagnosis of T2DM
- Adult patients has had consecutively undergone 24-hour Holter monitoring for heart rate variability analysis
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Type 2 diabetes Clinical examination and laboratory measurements With Clinical examination and laboratory measurements
- Primary Outcome Measures
Name Time Method Association between HRV and renal function (eGFR and UACR) 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
- Secondary Outcome Measures
Name Time Method Clinical characteristics of patients 1week Clinical examination and laboratory measurements Subjects were interviewed by a physician regarding their medical history, history of hypoglycemic attacks, smoking status, and alcohol consumption. A trained examiner measured the height (in meters) and body weight (in kilograms) of the patients. Body mass index (BMI) in kg/m\^2, weight in kilograms, height in meters. Hypertension was defined as systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg, or both, or if the patient was already taking anti-hypertensive drugs. Blood and urine samples were analyzed at the medical examination center of Kunming First People's Hospital.
Trial Locations
- Locations (1)
Internal medicine department, Kunming First People's Hospital
🇨🇳Kunming, Yunnan, China