Clinical trial NCT02996539: Heart Rate Variability and Diabetic Kidney Disease in Type 2 Diabetes Mellitus Patients
Official title: Heart Rate Variability and Diabetic Kidney Disease in Type 2 Diabetes Mellitus Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes Mellitus
Lead sponsor: First People's Hospital of Kunming
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: 392 patients of T2DM consecutively recruited from February 2013 to April 2015 in the inpatient department of Kunming First People's Hospital.The Institutional Review Board of Kunming First People's Hospital approved the study protocol. Adult patients with T2DM who had consecutively undergone 24-hour Holter monitoring for HRV analysis were included.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Association between HRV and renal function (eGFR and UACR)
timeFrame: 1week
Secondary outcomes:
measure: Clinical characteristics of patients
timeFrame: 1week
Other outcomes:
Locations:
city: Kunming
country: China
facility: Internal medicine department, Kunming First People's Hospital
state: Yunnan
Study officials:
affiliation: Kunming first people's hospital
name: Xiaolei Chen, MM
role: STUDY_CHAIR
References:
citation: 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.