<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/NCT04403945</url>
  </required_header>
  <id_info>
    <org_study_id>PVSDFI-DN</org_study_id>
    <nct_id>NCT04403945</nct_id>
  </id_info>
  <brief_title>The Predictive Value of Sidestream Dark Field Imaging in Diabetic Nephropathy</brief_title>
  <official_title>The Predictive Value of Sidestream Dark Field Imaging in Diabetic Nephropathy: a Observational Clinical Trial Evaluating the Predictive Value of SDF in DN</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Third Military Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetic microangiopathy refers to the pathological changes of arterioles, capillaries and&#xD;
      venules in diabetic patients. Due to the impacts including glycol-metabolism disorder,&#xD;
      disturbance of lipid metabolism, cytokine, oxidative stress and hemodynamic changes, the&#xD;
      structure and function of microvessels are damaged accordingly. Diabetic nephropathy (DN) is&#xD;
      one of the most common and serious chronic microvascular complications of diabetes, and&#xD;
      becomes a leading cause of end-stage renal failure(ESRF). Presently, urinary&#xD;
      albumin/creatinine ratio (UACR) is a widely accepted and relatively reliable indicator for&#xD;
      early diagnosis of DN, however, there are 2/3 DN patients with normal albuminuria have&#xD;
      decreased glomerular filtration rate (glomerular filtration rate, GFR) and abnormal structure&#xD;
      of the kidney, one the other hand, the presence of albuminuria is associated with other&#xD;
      vascular dysfunction and kidney disease other than DN, therefore its accuracy is increasingly&#xD;
      being challenged.&#xD;
&#xD;
      Sidestream dark field(SDF) imagining technology, as an emerging way to visualize blood&#xD;
      vessels, is evaluated in a semi-quantitative manner and provides an effective means to study&#xD;
      structure and function of microcirculation. Different from biochemical markers like&#xD;
      albuminuria, SDF provides a visual information about vessel structure, density, and quality&#xD;
      of diffusion. At present the research of sublingual microcirculation by SDF technique is&#xD;
      mainly applied to microcirculation monitoring in patients in the intensive care unit or&#xD;
      laboratory animal models with acute hemorrhagic shock to assess the potential of being a tool&#xD;
      of diagnosis and treatment prognostic indicator, no relevant research has been carried out to&#xD;
      evaluate the predictive value of diabetic microangiopathy in literature so far.&#xD;
&#xD;
      Herein, the investigators designed the study based on SDF imaging to collect scientific data,&#xD;
      thus providing strong support for the early assessment and diagnosis of diabetic nephropathy&#xD;
      and possibly guiding individual therapy in the future.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>21 Months</target_duration>
  <primary_outcome>
    <measure>the comparison of the density of total length of the small perfusd vessels(PDV) in the acquisition window between the 3 groups</measure>
    <time_frame>21 months</time_frame>
    <description>We use dark-field microcirculation microscopic observation System (Chinese Advanced Vessel Analyse Contrast System 4.0, C - AVA - C version 4.0) developed by Li Hua company to compare interesting parameters of vessels between the three groups. PVD is one of the parameters indicated of the perfused vessel density, calculated by the ratio of the length of small perfusion vessels to the visual field area (unit: mm/mm2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the comparison of The density of the total length of small vessels(TVD) in the area of the acquisition window between the 3 groups</measure>
    <time_frame>21 months</time_frame>
    <description>We use dark-field microcirculation microscopic observation System (Chinese Advanced Vessel Analyse Contrast System 4.0, C - AVA - C version 4.0) developed by Li Hua company to compare interesting parameters of vessels between the three groups. TVD is one of the parameters indicated of the total vessel density, calculated by the ratio of the length of all small vessels to the visual field area (unit: mm/mm2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the comparison of Proportion of De Backer density score between the 3 groups</measure>
    <time_frame>21 months</time_frame>
    <description>The score is the result of counting the number of intersections of capillaries with predetermined grid lines and measurement of total capillary length relative to image surface are similarly reliable measures of functional capillary density</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation comparison: The correlation between SDF vascular parameters and the clinical data of the subjects was compared</measure>
    <time_frame>21 months</time_frame>
    <description>Main clinical data:1. microalbuminuria；2.microalbuminuria creatinine ratio；3.Ankle brachial index；4.toe brachial index</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">143</enrollment>
  <condition>Microcirculation Detection in Diabetic Patients</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>healthy volunteers with normal fasting blood glucose and HbA1c, without hypertension, kidney diseases, or taking drugs that affects microcirculation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>type 2 diabetic patients without microvascular complications like Diabetic nephropathy, diabetic retinopathy, diabetic foot or diabetic peripheral neuropathy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>type 2 diabetic patients with diabetic nephropathy diagnosed by clinic or pathology.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sidestream dark field(SDF) imagining</intervention_name>
    <description>SDF imaging consists of a hand-held device that illuminates a region by surrounding a central light guide with concentrically placed light emitting diodes,which thus provide SDF illumination.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We collected clinical data of 100 cases with T2DM who hospitalized in our treatment center&#xD;
        from March 2019 to September 2020, and SDFI was taken properly.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ranges from 18 to 70 years old&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 18 years old or older than 70 years old&#xD;
&#xD;
          -  Shock patients who have low blood pressure under 90/60mmHg&#xD;
&#xD;
          -  Patients with mental abnormality who are uncooperative with this study&#xD;
&#xD;
          -  Having difficulty in mouth opening&#xD;
&#xD;
          -  Patients with Ketoacidosis&#xD;
&#xD;
          -  Oral mucosal inflammation or injury, which could locally influence the sublingual&#xD;
             microvasculature&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Refuse to sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The third hospital affiliated to the Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 24, 2021</last_update_submitted>
  <last_update_submitted_qc>July 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Third Military Medical University</investigator_affiliation>
    <investigator_full_name>Zhiming Zhu</investigator_full_name>
    <investigator_title>Director of the department of Hypertension &amp; Endocrinology, Daping Hospital</investigator_title>
  </responsible_party>
  <keyword>Type 2 Diabetes Mellitus; Sidestream dark field imaging; sublingual microcirculation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Nephropathies</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/NCT04403945
org study id: PVSDFI-DN
nct id: NCT04403945
lead sponsor: 
has dmc: No
is fda regulated device: No
Diabetic microangiopathy refers to the pathological changes of arterioles, capillaries and
      venules in diabetic patients. Due to the impacts including glycol-metabolism disorder,
      disturbance of lipid metabolism, cytokine, oxidative stress and hemodynamic changes, the
      structure and function of microvessels are damaged accordingly. Diabetic nephropathy (DN) is
      one of the most common and serious chronic microvascular complications of diabetes, and
      becomes a leading cause of end-stage renal failure(ESRF). Presently, urinary
      albumin/creatinine ratio (UACR) is a widely accepted and relatively reliable indicator for
      early diagnosis of DN, however, there are 2/3 DN patients with normal albuminuria have
      decreased glomerular filtration rate (glomerular filtration rate, GFR) and abnormal structure
      of the kidney, one the other hand, the presence of albuminuria is associated with other
      vascular dysfunction and kidney disease other than DN, therefore its accuracy is increasingly
      being challenged.

      Sidestream dark field(SDF) imagining technology, as an emerging way to visualize blood
      vessels, is evaluated in a semi-quantitative manner and provides an effective means to study
      structure and function of microcirculation. Different from biochemical markers like
      albuminuria, SDF provides a visual information about vessel structure, density, and quality
      of diffusion. At present the research of sublingual microcirculation by SDF technique is
      mainly applied to microcirculation monitoring in patients in the intensive care unit or
      laboratory animal models with acute hemorrhagic shock to assess the potential of being a tool
      of diagnosis and treatment prognostic indicator, no relevant research has been carried out to
      evaluate the predictive value of diabetic microangiopathy in literature so far.

      Herein, the investigators designed the study based on SDF imaging to collect scientific data,
      thus providing strong support for the early assessment and diagnosis of diabetic nephropathy
      and possibly guiding individual therapy in the future.
observational model: Case-Control
time perspective: Cross-Sectional
measure: the comparison of the density of total length of the small perfusd vessels(PDV) in the acquisition window between the 3 groups
time frame: 21 months
description: We use dark-field microcirculation microscopic observation System (Chinese Advanced Vessel Analyse Contrast System 4.0, C - AVA - C version 4.0) developed by Li Hua company to compare interesting parameters of vessels between the three groups. PVD is one of the parameters indicated of the perfused vessel density, calculated by the ratio of the length of small perfusion vessels to the visual field area (unit: mm/mm2)
measure: the comparison of The density of the total length of small vessels(TVD) in the area of the acquisition window between the 3 groups
time frame: 21 months
description: We use dark-field microcirculation microscopic observation System (Chinese Advanced Vessel Analyse Contrast System 4.0, C - AVA - C version 4.0) developed by Li Hua company to compare interesting parameters of vessels between the three groups. TVD is one of the parameters indicated of the total vessel density, calculated by the ratio of the length of all small vessels to the visual field area (unit: mm/mm2)
measure: the comparison of Proportion of De Backer density score between the 3 groups
time frame: 21 months
description: The score is the result of counting the number of intersections of capillaries with predetermined grid lines and measurement of total capillary length relative to image surface are similarly reliable measures of functional capillary density
measure: Correlation comparison: The correlation between SDF vascular parameters and the clinical data of the subjects was compared
time frame: 21 months
description: Main clinical data:1. microalbuminuria；2.microalbuminuria creatinine ratio；3.Ankle brachial index；4.toe brachial index
arm group label: Group 1
description: healthy volunteers with normal fasting blood glucose and HbA1c, without hypertension, kidney diseases, or taking drugs that affects microcirculation
arm group label: Group 2
description: type 2 diabetic patients without microvascular complications like Diabetic nephropathy, diabetic retinopathy, diabetic foot or diabetic peripheral neuropathy
arm group label: Group 3
description: type 2 diabetic patients with diabetic nephropathy diagnosed by clinic or pathology.
intervention type: Device
intervention name: Sidestream dark field(SDF) imagining
description: SDF imaging consists of a hand-held device that illuminates a region by surrounding a central light guide with concentrically placed light emitting diodes,which thus provide SDF illumination.
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Third Military Medical University
investigator full name: Zhiming Zhu
investigator title: Director of the department of Hypertension & Endocrinology, Daping Hospital
mesh term: Diabetic Nephropathies