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

NCT02996539 | Completed DMC

• 1 other identifier: FirstPHKunming
• Study Type: observational
• Target: 392
• Locations: 1 country
• Sites: 1

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).

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Clinical characteristics of patients

  1week

Study Arms (1)

Type 2 diabetes

With Clinical examination and laboratory measurements

Other: Clinical examination and laboratory measurements

Interventions

Clinical examination and laboratory measurements OTHER

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.

Also known as: Physical examination and blood urine samples collection

Type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shi wei, MM: lead

Study Sites (1)

Internal medicine department, Kunming First People's Hospital

Kunming, Yunnan, 650000, China

Location

Related 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.

  PMID: 25249672 BACKGROUND

Related Links

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MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Xiaolei Chen, MM

  Kunming first people's hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 19, 2016
• Study Start: February 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: December 19, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)