<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02996539</url>
  </required_header>
  <id_info>
    <org_study_id>FirstPHKunming</org_study_id>
    <nct_id>NCT02996539</nct_id>
  </id_info>
  <brief_title>Heart Rate Variability and Diabetic Kidney Disease in Type 2 Diabetes Mellitus Patients</brief_title>
  <official_title>Heart Rate Variability and Diabetic Kidney Disease in Type 2 Diabetes Mellitus Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shi wei, MM</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First People's Hospital of Kunming</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several studies have investigated an association between cardiac autonomic neuropathy (CAN)&#xD;
      and albuminuria, glomerular filtration rate, or both, and hypothesized that CAN is involved&#xD;
      in the pathogenesis of nephropathy. However, most of these studies had focused on Caucasians&#xD;
      and were limited to a small number of patients with type 1 diabetes mellitus, or had used a&#xD;
      conventional Ewing battery of tests based on dynamic cardiovascular maneuvers.Yet, there is&#xD;
      consistent data showing that Asian diabetic populations, including the Chinese, have a higher&#xD;
      risk of renal complications than Caucasians do.&#xD;
&#xD;
      The present study investigated an association between heart rate variability (HRV) parameters&#xD;
      and diabetic kidney disease (DKD) in Chinese type 2 diabetes mellitus (T2DM) patients,&#xD;
      specifically through time and frequency domain analyses of HRV and urine albumin creatinine&#xD;
      ratio (UACR) or estimated glomerular filtration rate (eGFR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      present study investigated an association between HRV parameters and DKD in Chinese T2DM&#xD;
      patients, specifically through time and frequency domain analyses of HRV and UACR or eGFR&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Association between HRV and renal function (eGFR and UACR)</measure>
    <time_frame>1week</time_frame>
    <description>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 &lt; 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 &lt; 60 mL/min/1.73 m^2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical characteristics of patients</measure>
    <time_frame>1week</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">392</enrollment>
  <condition>Type2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Type 2 diabetes</arm_group_label>
    <description>With Clinical examination and laboratory measurements</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical examination and laboratory measurements</intervention_name>
    <description>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.</description>
    <arm_group_label>Type 2 diabetes</arm_group_label>
    <other_name>Physical examination and blood urine samples collection</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        392 patients of T2DM consecutively recruited from February 2013 to April 2015 in the&#xD;
        inpatient department of Kunming First People's Hospital.The Institutional Review Board of&#xD;
        Kunming First People's Hospital approved the study protocol. Adult patients with T2DM who&#xD;
        had consecutively undergone 24-hour Holter monitoring for HRV analysis were included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of T2DM&#xD;
&#xD;
          -  Adult patients has had consecutively undergone 24-hour Holter monitoring for heart&#xD;
             rate variability analysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with acute complications of DM including diabetic ketoacidosis, hyperosmolar&#xD;
             coma&#xD;
&#xD;
          -  Foot ulcer&#xD;
&#xD;
          -  Severe acute or chronic infection&#xD;
&#xD;
          -  Chronic liver disease&#xD;
&#xD;
          -  Dialysis or renal transplantation&#xD;
&#xD;
          -  The presence of any serious concomitant disease affecting life expectancy were not&#xD;
             eligible for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaolei Chen, MM</last_name>
    <role>Study Chair</role>
    <affiliation>Kunming first people's hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Internal medicine department, Kunming First People's Hospital</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.cma.org</url>
    <description>test link</description>
  </link>
  <reference>
    <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.</citation>
    <PMID>25249672</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>First People's Hospital of Kunming</investigator_affiliation>
    <investigator_full_name>Shi wei, MM</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Diabetic Nephropathies</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The basic records of patients</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02996539
org study id: FirstPHKunming
nct id: NCT02996539
lead sponsor: 
has dmc: Yes
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).
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
observational model: Case-Only
measure: Association between HRV and renal function (eGFR and UACR)
time frame: 1week
description: 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
measure: Clinical characteristics of patients
time frame: 1week
description: 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.
arm group label: Type 2 diabetes
description: With Clinical examination and laboratory measurements
intervention type: Other
intervention name: Clinical examination and laboratory measurements
description: 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.
arm group label: Type 2 diabetes
other name: Physical examination and blood urine samples collection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Xiaolei Chen, MM
role: Study Chair
affiliation: Kunming first people's hospital
facility: 
country: China
url: http://www.cma.org
description: test link
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.
PMID: 25249672
responsible party type: Sponsor-Investigator
investigator affiliation: First People's Hospital of Kunming
investigator full name: Shi wei, MM
investigator title: Director
mesh term: Kidney Diseases
mesh term: Diabetic Nephropathies
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Yes
ipd description: The basic records of patients