Heart Rate Variability and Diabetic Kidney Disease in Type 2 Diabetes Mellitus Patients

Sponsor

Shi wei, MM (Other)

Overall Status

Completed

CT.gov ID

NCT02996539

Collaborator

(none)

392

Enrollment

Location

25.9

Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Type2 Diabetes Mellitus	Other: Clinical examination and laboratory measurements

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

Study Design

Study Type:

Observational

Actual Enrollment :

392 participants

Observational Model:

Case-Only

Official Title:

Heart Rate Variability and Diabetic Kidney Disease in Type 2 Diabetes Mellitus Patients

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Type 2 diabetes With Clinical examination and laboratory measurements	Other: Clinical examination and laboratory measurements Subjects were interviewed by a physician regarding their medical history, history of hypoglycemic attacks, smoking status, and alcohol consumption. Concentrations of blood urea nitrogen (BUN) and serum creatinine (SCr) were analyzed by the urease-ultraviolet rate method and picric acid method, respectively. Serum uric acid was determined using the enzymatic colorimetric method. Serum hemoglobin A1c (HbA1c) was measured by liquid enzymatic assay. Urine albumin and urine creatinine were found through immune turbidimetric analysis and the enzymatic method, respectively. Other Names: Physical examination and blood urine samples collection

Arm

Intervention/Treatment

Type 2 diabetes

With Clinical examination and laboratory measurements

Other: Clinical examination and laboratory measurements

Subjects were interviewed by a physician regarding their medical history, history of hypoglycemic attacks, smoking status, and alcohol consumption. Concentrations of blood urea nitrogen (BUN) and serum creatinine (SCr) were analyzed by the urease-ultraviolet rate method and picric acid method, respectively. Serum uric acid was determined using the enzymatic colorimetric method. Serum hemoglobin A1c (HbA1c) was measured by liquid enzymatic assay. Urine albumin and urine creatinine were found through immune turbidimetric analysis and the enzymatic method, respectively.

Other Names:

Physical examination and blood urine samples collection

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of T2DM
Adult patients has had consecutively undergone 24-hour Holter monitoring for heart rate variability analysis

Exclusion Criteria:

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.