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

December 14, 2016 updated by: Shi wei, MM

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

392

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Internal medicine department, Kunming First People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between HRV and renal function (eGFR and UACR)
Time Frame: 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
1week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical characteristics of patients
Time Frame: 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.
1week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shi wei, MM

Investigators

  • Study Chair: Xiaolei Chen, MM, Kunming First People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

November 24, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimate)

December 19, 2016

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstPHKunming

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The basic records of patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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