<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/NCT03284996</url>
  </required_header>
  <id_info>
    <org_study_id>DUDN</org_study_id>
    <nct_id>NCT03284996</nct_id>
  </id_info>
  <brief_title>Doppler Ultrasound in Early Detection of Diabetic Nephropathy Type 2 Diabetes Mellitus.</brief_title>
  <official_title>Role of Doppler Ultrasound in Early Detection of Diabetic Nephropathy in Patients With Type 2 Diabetes Mellitus.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Doppler sonography provides an easily applicable, non-invasive, and well-established method&#xD;
      for investigating renal morphologic characteristics and measuring vascular resistance in the&#xD;
      renal parenchyma. Doppler are of strategic importance in providing qualitative and&#xD;
      quantitative information about the renal vasculature, which can be obtained through the&#xD;
      assessment of the resistive index.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nephropathy is one of the most common long-term, life-threatening complications causing a&#xD;
      high rate of morbidity and mortality among individual patients with type 2 diabetes.&#xD;
&#xD;
      The onset and progression of nephropathy can be delayed by interventions, provided they are&#xD;
      instituted early in the course of the disease.&#xD;
&#xD;
      Doppler sonography allows non-invasive method for investigating renal hemodynamics. Renal&#xD;
      resistive index measured using Doppler ultrasonography, reflects intra-renal vascular&#xD;
      resistance.&#xD;
&#xD;
      Although Doppler sonography clearly does not substitute for renal biopsy, several studies&#xD;
      have suggested that it might aid in the management of established renal disease and provide&#xD;
      an easily applicable and noninvasive method for investigating renal hemodynamics.&#xD;
&#xD;
      Doppler sonography provides an easily applicable, non-invasive, and well-established method&#xD;
      for investigating renal morphologic characteristics and measuring vascular resistance in the&#xD;
      renal parenchyma. Doppler are of strategic importance in providing qualitative and&#xD;
      quantitative information about the renal vasculature, which can be obtained through the&#xD;
      assessment of the resistive index. It is one of the most sensitive parameters in the study of&#xD;
      kidney diseases and allows us to quantify the changes in renal plasma flow . A normal&#xD;
      resistive index is below 0.7 in adults and children who are six years of age or older.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Early detection of diabetic nephropathy in patients with type 2 diabetes mellitus by measuring changes in renal resistive index using Doppler ultrasonography</measure>
    <time_frame>2 years</time_frame>
    <description>Early detection of diabetic nephropathy in patients with type 2 diabetes mellitus by measuring changes in renal resistive index using Doppler ultrasonography</description>
  </primary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Diabetic Nephropathies</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Doppler ultrasonography</intervention_name>
    <description>Examination of the whole cases &amp; controls by doppler ultrasound to measure renal resistive index.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study was designed as a single-center case control study in which we'll evaluate&#xD;
        intra-renal hemodynamic changes with Doppler sonography in diabetic patients in comparison&#xD;
        to non-diabetic controls, by studying 80 cases, 40 cases of patients with type 2 diabetes&#xD;
        mellitus from the diabetes &amp; nephrology outpatient clinic in Assiut University Hospital&#xD;
        (group A) and 40 age-matched healthy adults served as a control group (group B).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Type 2 diabetic patients. 2. Serum creatinine &lt;1.2 mg/dl&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - 1. patients with known history of renal disease or any systemic diseases with renal&#xD;
        complications.&#xD;
&#xD;
        2. Serum creatinine &gt;1.2 mg/dl&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hassan Ibrahim Megally, Professor</last_name>
    <phone>00201006209845</phone>
    <email>hasanibrahim48@aun.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Abolhassan Hasseeb Mohamed, Lecturer</last_name>
    <phone>00201009562059</phone>
    <email>abolhasan_96@aun.edu.eg</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Nelson TR, Pretorius DH. The Doppler signal: where does it come from and what does it mean? AJR Am J Roentgenol. 1988 Sep;151(3):439-47. doi: 10.2214/ajr.151.3.439.</citation>
    <PMID>2970215</PMID>
  </results_reference>
  <results_reference>
    <citation>Tublin ME, Bude RO, Platt JF. Review. The resistive index in renal Doppler sonography: where do we stand? AJR Am J Roentgenol. 2003 Apr;180(4):885-92. doi: 10.2214/ajr.180.4.1800885. No abstract available.</citation>
    <PMID>12646425</PMID>
  </results_reference>
  <results_reference>
    <citation>Tang SC, Chan GC, Lai KN. Recent advances in managing and understanding diabetic nephropathy. F1000Res. 2016 May 31;5:F1000 Faculty Rev-1044. doi: 10.12688/f1000research.7693.1. eCollection 2016.</citation>
    <PMID>27303648</PMID>
  </results_reference>
  <results_reference>
    <citation>Mancini M, Masulli M, Liuzzi R, Mainenti PP, Ragucci M, Maurea S, Riccardi G, Vaccaro O. Renal duplex sonographic evaluation of type 2 diabetic patients. J Ultrasound Med. 2013 Jun;32(6):1033-40. doi: 10.7863/ultra.32.6.1033.</citation>
    <PMID>23716525</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Shery Dawood Yassa</investigator_full_name>
    <investigator_title>Principal investigator</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>
  <!-- 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/NCT03284996
org study id: DUDN
nct id: NCT03284996
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Doppler sonography provides an easily applicable, non-invasive, and well-established method
      for investigating renal morphologic characteristics and measuring vascular resistance in the
      renal parenchyma. Doppler are of strategic importance in providing qualitative and
      quantitative information about the renal vasculature, which can be obtained through the
      assessment of the resistive index.
Nephropathy is one of the most common long-term, life-threatening complications causing a
      high rate of morbidity and mortality among individual patients with type 2 diabetes.

      The onset and progression of nephropathy can be delayed by interventions, provided they are
      instituted early in the course of the disease.

      Doppler sonography allows non-invasive method for investigating renal hemodynamics. Renal
      resistive index measured using Doppler ultrasonography, reflects intra-renal vascular
      resistance.

      Although Doppler sonography clearly does not substitute for renal biopsy, several studies
      have suggested that it might aid in the management of established renal disease and provide
      an easily applicable and noninvasive method for investigating renal hemodynamics.

      Doppler sonography provides an easily applicable, non-invasive, and well-established method
      for investigating renal morphologic characteristics and measuring vascular resistance in the
      renal parenchyma. Doppler are of strategic importance in providing qualitative and
      quantitative information about the renal vasculature, which can be obtained through the
      assessment of the resistive index. It is one of the most sensitive parameters in the study of
      kidney diseases and allows us to quantify the changes in renal plasma flow . A normal
      resistive index is below 0.7 in adults and children who are six years of age or older.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Early detection of diabetic nephropathy in patients with type 2 diabetes mellitus by measuring changes in renal resistive index using Doppler ultrasonography
time frame: 2 years
description: Early detection of diabetic nephropathy in patients with type 2 diabetes mellitus by measuring changes in renal resistive index using Doppler ultrasonography
intervention type: Device
intervention name: Doppler ultrasonography
description: Examination of the whole cases & controls by doppler ultrasound to measure renal resistive index.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hassan Ibrahim Megally, Professor
phone: 00201006209845
email: hasanibrahim48@aun.edu.eg
last name: Abolhassan Hasseeb Mohamed, Lecturer
phone: 00201009562059
email: abolhasan_96@aun.edu.eg
citation: Nelson TR, Pretorius DH. The Doppler signal: where does it come from and what does it mean? AJR Am J Roentgenol. 1988 Sep;151(3):439-47. doi: 10.2214/ajr.151.3.439.
PMID: 2970215
citation: Tublin ME, Bude RO, Platt JF. Review. The resistive index in renal Doppler sonography: where do we stand? AJR Am J Roentgenol. 2003 Apr;180(4):885-92. doi: 10.2214/ajr.180.4.1800885. No abstract available.
PMID: 12646425
citation: Tang SC, Chan GC, Lai KN. Recent advances in managing and understanding diabetic nephropathy. F1000Res. 2016 May 31;5:F1000 Faculty Rev-1044. doi: 10.12688/f1000research.7693.1. eCollection 2016.
PMID: 27303648
citation: Mancini M, Masulli M, Liuzzi R, Mainenti PP, Ragucci M, Maurea S, Riccardi G, Vaccaro O. Renal duplex sonographic evaluation of type 2 diabetic patients. J Ultrasound Med. 2013 Jun;32(6):1033-40. doi: 10.7863/ultra.32.6.1033.
PMID: 23716525
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Shery Dawood Yassa
investigator title: Principal investigator
mesh term: Kidney Diseases
mesh term: Diabetic Nephropathies
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2