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

Type2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996539
• Other study ID #: FirstPHKunming
• Status: Completed
• Phase: N/A
• First received: November 24, 2016
• Last updated: December 14, 2016
• Start date: February 2013
• Est. completion date: April 2015

Study information

• Verified date: December 2016
• Source: First People's Hospital of Kunming
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Kidney Diseases
• Type2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
China	Internal medicine department, Kunming First People's Hospital	Kunming	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
Shi wei, MM

Country where clinical trial is conducted

China, 

References & Publications (1)

Tuttle KR, Bakris GL, Bilous RW, Chiang JL, de Boer IH, Goldstein-Fuchs J, Hirsch IB, Kalantar-Zadeh K, Narva AS, Navaneethan SD, Neumiller JJ, Patel UD, Ratner RE, Whaley-Connell AT, Molitch ME. Diabetic kidney disease: a report from an ADA Consensus Conference. Diabetes Care. 2014 Oct;37(10):2864-83. doi: 10.2337/dc14-1296. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association between HRV and renal function (eGFR and UACR)	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	1week	No
Secondary	Clinical characteristics of patients	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.	1week	No

External Links

•   test link