<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/NCT02204280</url>
  </required_header>
  <id_info>
    <org_study_id>HebeiMUTH</org_study_id>
    <nct_id>NCT02204280</nct_id>
  </id_info>
  <brief_title>The Significance of Urine UbA52 In the Diagnosis of Diabetic Nephropathy</brief_title>
  <official_title>Urine UbA52 is a Biomarker of Early Diabetic Nephropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hebei Medical University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hebei Medical University Third Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Definite diagnosis of diabetic nephropathy is currently based on renal biopsy findings. In&#xD;
      most cases, however, the diagnosis can be reliably made in patients with macroalbuminuria in&#xD;
      the presence of diabetic retinopathy.Microalbuminuria is often used as a prognostic marker in&#xD;
      type 1 diabetes, because approximately 50% of type 1 diabetes patients with microalbuminuria&#xD;
      will eventually develop diabetic nephropathy. Conversely, microalbu- minuria is of much less&#xD;
      value as a marker in DM because it has a variety of causes, including hypertension. Thus,&#xD;
      additional markers are needed to identify patient groups with a high risk of developing overt&#xD;
      diabetic nephropathy. The aims of this study is checking urine UbA52 levels with ELISA to&#xD;
      identify its significance in the diagnosis of diabetic nephropathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is now well recognized that the incidence of diabetes is increasing worldwide. It is the&#xD;
      leading cause of end-stage renal disease (ESRD) in Western countries. Diabetic nephropathy&#xD;
      has been reported to occur in 25%-40% of people with diabetes. The appearance of&#xD;
      microalbuminuria usually is regarded as incipient nephropathy, but recently, work has&#xD;
      suggested that some individuals with diabetes and decreased GFR may not have an increased&#xD;
      urinary AER.Identification of markers for prediction of the clinical course of diabetic&#xD;
      nephropathy remains a major challenge. Previous research showed that m/z14766 protein by mass&#xD;
      spectrometry, was selectively excreted in the urine of diabetic nephropathy patients, the m/z&#xD;
      14766 mass peaks were identified as UbA52. We suppose that UbA52 can be regard as a simple&#xD;
      and practical biomarker for diagnosis of diabetic nephropathy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>The urine UbA52 levels in 30 patients with type 2 diabetic mellitus,30 patients with diabetic nephropathy，30 patients with proteinuria due to nondiabetic renal disease and 30 healthy persons</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Diabetic Nephropathy</condition>
  <arm_group>
    <arm_group_label>Type 2 Diabetic</arm_group_label>
    <description>Patiens with type 2 diabetic which conform to the WHO in 1999 diabetes diagnostic criteria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diabetic With macro-or Microalbuminuria</arm_group_label>
    <description>Patients with diabetic with macro-or microalbuminuria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>proteinuria,nondiabetic renal disease</arm_group_label>
    <description>Patients with proteinuria due to nondiabetic renal disease,such as IgA nephropathy,FSGS,Hypertensive renal damage and MN.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy controls</arm_group_label>
    <description>Healthy person.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      morning urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        patients with type 2 diabetic,diabetic with macro-or microalbuminuria and proteinuria due&#xD;
        to nondiabetic renal disease from Hebei Medical University the Third Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. diabetes diagnostic criteria (WHO, 1999),age &lt; 80 years old, gender not limited;&#xD;
&#xD;
          2. diabetic with macro-or microalbuminuria;&#xD;
&#xD;
          3. the subjects not took hemodialysis;&#xD;
&#xD;
          4. with proteinuria due to nondiabetic renal disease :Hypertensive renal&#xD;
             damage,drug-induced acute interstitial nephritis, IgA, primary membranous&#xD;
             nephropathy,FSGS or MCD, which were confirmed by renal biopsy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. acute diabetic complications: ketoacidosis, hypertonic coma;&#xD;
&#xD;
          2. the diagnosis of malignant tumors, particularly affecting the liver and kidney&#xD;
             function of tumor and the application of radiation and chemotherapy treatment of&#xD;
             patients;&#xD;
&#xD;
          3. cardiac insufficiency, heart function class 3 or above;&#xD;
&#xD;
          4. data is not complete, have an impact on the results;&#xD;
&#xD;
          5. not hospitalized patients;&#xD;
&#xD;
          6. accept long-term oral or static point methods such as steroid hormone therapy,&#xD;
             application of renal toxicity of drugs;&#xD;
&#xD;
          7. with the exception of primary kidney disease and other causes lead to eye disease;&#xD;
&#xD;
          8. the combination of respiratory system infection or other systemic diseases and&#xD;
             patients with severe primary diseases, vigorous exercise within 24 hours;&#xD;
&#xD;
          9. pregnancy or breastfeeding women&#xD;
&#xD;
         10. there is a clear liver disease, its alanine or aspertate aminotransferase 2 times&#xD;
             higher than normal limit;&#xD;
&#xD;
         11. reluctant to collaborators and psychiatric patients;&#xD;
&#xD;
         12. has been undergoing hemodialysis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>July 20, 2015</last_update_submitted>
  <last_update_submitted_qc>July 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>UbA52;diabetic nephropathy ;diabetic;ELISA</keyword>
  <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>
  </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/NCT02204280
org study id: HebeiMUTH
nct id: NCT02204280
lead sponsor: 
collaborator: 
has dmc: Yes
Definite diagnosis of diabetic nephropathy is currently based on renal biopsy findings. In
      most cases, however, the diagnosis can be reliably made in patients with macroalbuminuria in
      the presence of diabetic retinopathy.Microalbuminuria is often used as a prognostic marker in
      type 1 diabetes, because approximately 50% of type 1 diabetes patients with microalbuminuria
      will eventually develop diabetic nephropathy. Conversely, microalbu- minuria is of much less
      value as a marker in DM because it has a variety of causes, including hypertension. Thus,
      additional markers are needed to identify patient groups with a high risk of developing overt
      diabetic nephropathy. The aims of this study is checking urine UbA52 levels with ELISA to
      identify its significance in the diagnosis of diabetic nephropathy.
It is now well recognized that the incidence of diabetes is increasing worldwide. It is the
      leading cause of end-stage renal disease (ESRD) in Western countries. Diabetic nephropathy
      has been reported to occur in 25%-40% of people with diabetes. The appearance of
      microalbuminuria usually is regarded as incipient nephropathy, but recently, work has
      suggested that some individuals with diabetes and decreased GFR may not have an increased
      urinary AER.Identification of markers for prediction of the clinical course of diabetic
      nephropathy remains a major challenge. Previous research showed that m/z14766 protein by mass
      spectrometry, was selectively excreted in the urine of diabetic nephropathy patients, the m/z
      14766 mass peaks were identified as UbA52. We suppose that UbA52 can be regard as a simple
      and practical biomarker for diagnosis of diabetic nephropathy.
observational model: Case-Control
time perspective: Cross-Sectional
measure: The urine UbA52 levels in 30 patients with type 2 diabetic mellitus,30 patients with diabetic nephropathy，30 patients with proteinuria due to nondiabetic renal disease and 30 healthy persons
time frame: 12 months
arm group label: Type 2 Diabetic
description: Patiens with type 2 diabetic which conform to the WHO in 1999 diabetes diagnostic criteria.
arm group label: Diabetic With macro-or Microalbuminuria
description: Patients with diabetic with macro-or microalbuminuria.
arm group label: proteinuria,nondiabetic renal disease
description: Patients with proteinuria due to nondiabetic renal disease,such as IgA nephropathy,FSGS,Hypertensive renal damage and MN.
arm group label: healthy controls
description: Healthy person.
morning urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Diabetic Nephropathies