<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/NCT04411342</url>
  </required_header>
  <id_info>
    <org_study_id>normoalbuminuric CKD in DM2</org_study_id>
    <nct_id>NCT04411342</nct_id>
  </id_info>
  <brief_title>Normoalbuminuric Chronic Kidney Disease in Type 2 Diabetes</brief_title>
  <official_title>Prevalence of Normoalbuminuric Chronic Kidney Disease and Its Risk Factors in Patients With Type 2 Diabetes Attending the Diabetes Center of Assiut University Hospital</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>
      -  Assess the prevalence of normoalbuminuric CKD in Type 2 diabetes.&#xD;
&#xD;
        -  Study the risk factors of normoalbuminuric CKD in patients with type 2 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes mellitus (DM) is considered a major cause of chronic kidney disease (CKD), where&#xD;
      about 40% of the diabetics develop diabetic kidney disease (DKD) resulting in albuminuria,&#xD;
      reduction of glomerular filtration rate (GFR), or both .&#xD;
&#xD;
      Albuminuria was widely considered the first clinical sign of DKD, therefore, it has been used&#xD;
      as a screening test for DKD. However, recent studies showed that a significant number of T2DM&#xD;
      patients have a decreased GFR with normoalbuminuria, known as non-albuminuric DKD (NA-DKD) .&#xD;
&#xD;
      The use of albuminuria as an early marker of DKD onset or progression requires a careful&#xD;
      interpretation because in diabetics, albuminuria has a great tendency to return to normal&#xD;
      spontaneously. Evidence based studies reported that about 18-51 percent of T2DM (followed&#xD;
      during 2-10 years) present first with albuminuria turn to normoalbuminurics spontaneously&#xD;
      during the period of follow-up .&#xD;
&#xD;
      The United Kingdom Prospective Diabetes Study (UKPDS) reported that some diabetics pass&#xD;
      directly from a normoalbuminuria to renal insufficiency (0.1% per year) .&#xD;
&#xD;
      Albuminuria as a marker of glomerular lesion progression has some limitations because of its&#xD;
      intra-patient variability and possibility of spontaneous regress (in &gt;50% of the patients&#xD;
      with low levels of albuminuria), in contrast with GFR that has low variability and infrequent&#xD;
      improvement .&#xD;
&#xD;
      Few of T2DM patients are presented without significant proteinuria but present with renal&#xD;
      insufficiency and developed DKD (i.e., estimated glomerular filtration rate (eGFR) &lt; 60&#xD;
      mL/min/1.73 m2), which was defined as normoalbuminuric diabetic kidney disease (NADKD) or&#xD;
      diabetic kidney disease without proteinuria where albuminuria does not associate with&#xD;
      impairment of kidney function .&#xD;
&#xD;
      The ADA criteria for diagnosis of DKD now involve the presence of eGFR &lt; 60 mL/min/1.73 m2 or&#xD;
      the presence of UAE &gt; 30 mg/24 h. In patients with NADKD, the risk factors include obesity,&#xD;
      hypertension, high TG levels, sex, smoking, poor glycemic control, and glomerular&#xD;
      hyperfiltration which play a role in nephrosclerosis. Macroangiopathy is also prevalent in&#xD;
      patients with NADKD .&#xD;
&#xD;
      Intrarenal arteriosclerosis is the main cause of renal impairment in type 2 diabetic patients&#xD;
      independent of albuminuria, and this partly cause eGFR decline in these patients. Several&#xD;
      studies also suggest that decline in renal function is mainly due to interstitial injury (a&#xD;
      pathological change in DN) as compared with glomerular injury .&#xD;
&#xD;
      Normoalbuminuria is associated with Diabetic kidney disease (DKD), which is the commonest&#xD;
      cause of end-stage renal disease (ESRD) all over the world. The clinical manifestations of&#xD;
      DKD consist of a progressive increase in albuminuria and a decline in estimated glomerular&#xD;
      filtration rate (eGFR) &lt;60 mL/min/1.73 m2. Hence, the diagnosis of DKD in patients with&#xD;
      declining renal function without albuminuria is more difficult. The decline of renal function&#xD;
      is slower in normoalbuminuria .&#xD;
&#xD;
      Tthe majority of patients with DKD had albuminuria, but a significant proportion had the&#xD;
      normoalbuminuric renal impairment (46.6%) . The prevalence of NADKD ranges globally from&#xD;
      14.29 to 56.6% among diabetic patients with different ethnicities .&#xD;
&#xD;
      The prevalence of NADKD is about 23.3% to 56.6% in T2DM patients with a decline in the renal&#xD;
      function presented with normal albuminuria . However, the prevalence at which the patients&#xD;
      develop normoalbuminuric renal impairment in Type 2 diabetes are not completely defined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of Normoalbuminuric chronic kidney disease</measure>
    <time_frame>Baseline</time_frame>
    <description>The required sample size(200 patients) has been calculated using the EPI info version which achieve power of study 80%.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <arm_group>
    <arm_group_label>patients with type 2 diabetes</arm_group_label>
    <description>patients with type 2 diabetes and have normal range of albumine in urine and decline in renal functions</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Albumin creatinine ratio</intervention_name>
    <description>normal range of albumin in urine in patients with type 2 diabetes</description>
    <arm_group_label>patients with type 2 diabetes</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with type 2 diabetes attending diadetes center of Assiut University&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age &gt;18 -65 years .&#xD;
&#xD;
          -  Diagnosed previously with T2DM.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with type 1 diabetes,&#xD;
&#xD;
               -  Patients with secondary diabetes,&#xD;
&#xD;
               -  Patients with gestational diabetes&#xD;
&#xD;
               -  Patients with severe acute or chronic hepatic or cardiac diseases.&#xD;
&#xD;
               -  Patients with Past or present history of malignancy .&#xD;
&#xD;
               -  Patients with in need for renal replacement therapy.&#xD;
&#xD;
               -  Patients with other probable causes for CKD.&#xD;
&#xD;
               -  Patients with an active urinary sediment and nephrotic - range proteinuria .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Martina Michael Wadae, master</last_name>
    <phone>01221277260</phone>
    <email>martina.michael13@gmail.com</email>
  </overall_contact>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>March 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Martina Michael Wadae</investigator_full_name>
    <investigator_title>clinical 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>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04411342
org study id: normoalbuminuric CKD in DM2
nct id: NCT04411342
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
-  Assess the prevalence of normoalbuminuric CKD in Type 2 diabetes.

        -  Study the risk factors of normoalbuminuric CKD in patients with type 2 diabetes.
Diabetes mellitus (DM) is considered a major cause of chronic kidney disease (CKD), where
      about 40% of the diabetics develop diabetic kidney disease (DKD) resulting in albuminuria,
      reduction of glomerular filtration rate (GFR), or both .

      Albuminuria was widely considered the first clinical sign of DKD, therefore, it has been used
      as a screening test for DKD. However, recent studies showed that a significant number of T2DM
      patients have a decreased GFR with normoalbuminuria, known as non-albuminuric DKD (NA-DKD) .

      The use of albuminuria as an early marker of DKD onset or progression requires a careful
      interpretation because in diabetics, albuminuria has a great tendency to return to normal
      spontaneously. Evidence based studies reported that about 18-51 percent of T2DM (followed
      during 2-10 years) present first with albuminuria turn to normoalbuminurics spontaneously
      during the period of follow-up .

      The United Kingdom Prospective Diabetes Study (UKPDS) reported that some diabetics pass
      directly from a normoalbuminuria to renal insufficiency (0.1% per year) .

      Albuminuria as a marker of glomerular lesion progression has some limitations because of its
      intra-patient variability and possibility of spontaneous regress (in >50% of the patients
      with low levels of albuminuria), in contrast with GFR that has low variability and infrequent
      improvement .

      Few of T2DM patients are presented without significant proteinuria but present with renal
      insufficiency and developed DKD (i.e., estimated glomerular filtration rate (eGFR) < 60
      mL/min/1.73 m2), which was defined as normoalbuminuric diabetic kidney disease (NADKD) or
      diabetic kidney disease without proteinuria where albuminuria does not associate with
      impairment of kidney function .

      The ADA criteria for diagnosis of DKD now involve the presence of eGFR < 60 mL/min/1.73 m2 or
      the presence of UAE > 30 mg/24 h. In patients with NADKD, the risk factors include obesity,
      hypertension, high TG levels, sex, smoking, poor glycemic control, and glomerular
      hyperfiltration which play a role in nephrosclerosis. Macroangiopathy is also prevalent in
      patients with NADKD .

      Intrarenal arteriosclerosis is the main cause of renal impairment in type 2 diabetic patients
      independent of albuminuria, and this partly cause eGFR decline in these patients. Several
      studies also suggest that decline in renal function is mainly due to interstitial injury (a
      pathological change in DN) as compared with glomerular injury .

      Normoalbuminuria is associated with Diabetic kidney disease (DKD), which is the commonest
      cause of end-stage renal disease (ESRD) all over the world. The clinical manifestations of
      DKD consist of a progressive increase in albuminuria and a decline in estimated glomerular
      filtration rate (eGFR) <60 mL/min/1.73 m2. Hence, the diagnosis of DKD in patients with
      declining renal function without albuminuria is more difficult. The decline of renal function
      is slower in normoalbuminuria .

      Tthe majority of patients with DKD had albuminuria, but a significant proportion had the
      normoalbuminuric renal impairment (46.6%) . The prevalence of NADKD ranges globally from
      14.29 to 56.6% among diabetic patients with different ethnicities .

      The prevalence of NADKD is about 23.3% to 56.6% in T2DM patients with a decline in the renal
      function presented with normal albuminuria . However, the prevalence at which the patients
      develop normoalbuminuric renal impairment in Type 2 diabetes are not completely defined.
observational model: Other
time perspective: Cross-Sectional
measure: Prevalence of Normoalbuminuric chronic kidney disease
time frame: Baseline
description: The required sample size(200 patients) has been calculated using the EPI info version which achieve power of study 80%.
arm group label: patients with type 2 diabetes
description: patients with type 2 diabetes and have normal range of albumine in urine and decline in renal functions
intervention type: Diagnostic Test
intervention name: Albumin creatinine ratio
description: normal range of albumin in urine in patients with type 2 diabetes
arm group label: patients with type 2 diabetes
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
last name: Martina Michael Wadae, master
phone: 01221277260
email: martina.michael13@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Martina Michael Wadae
investigator title: clinical investigator
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No