<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/NCT01671969</url>
  </required_header>
  <id_info>
    <org_study_id>VLCD1</org_study_id>
    <nct_id>NCT01671969</nct_id>
  </id_info>
  <brief_title>Very Low Calorie Diet for Diabetic Kidney Disease</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a very low calorie diet will stabilize or&#xD;
      improve diabetic kidney disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary albumin excretion</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Diabetic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>very low calorie diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>very low calorie diet</intervention_name>
    <description>medically supervised diet</description>
    <arm_group_label>very low calorie diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 Diabetes&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  Body mass index ≥ 30&#xD;
&#xD;
          -  Presumed or biopsy-proven diabetic nephropathy&#xD;
&#xD;
          -  Estimated GFR &lt; 40 ml/min/1.73 meters squared&#xD;
&#xD;
          -  Proteinuria &gt; 0.5 gm/day&#xD;
&#xD;
          -  Motivated to lose weight&#xD;
&#xD;
          -  Stable medical co-morbidities&#xD;
&#xD;
          -  Using an ACE inhibitor or angiotensin receptor blocker agent (unless contraindicated)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to sign informed consent&#xD;
&#xD;
          -  Life expectancy of &lt; 1 year&#xD;
&#xD;
          -  Expected need for initiation of dialysis within 9 months&#xD;
&#xD;
          -  Type 1 Diabetes&#xD;
&#xD;
          -  Recent myocardial infarction or stroke (past 3 months)&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  Active cancer&#xD;
&#xD;
          -  Pregnancy/lactation&#xD;
&#xD;
          -  Serious psychiatric diseases&#xD;
&#xD;
          -  Substance abuse&#xD;
&#xD;
          -  Uncontrolled hypertension (&gt; 180/110)&#xD;
&#xD;
          -  Ineligible for VLCD based on laboratory data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>March 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>August 27, 2015</last_update_submitted>
  <last_update_submitted_qc>August 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>determine effects of diet on renal and other parameters</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/NCT01671969
org study id: VLCD1
nct id: NCT01671969
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether a very low calorie diet will stabilize or
      improve diabetic kidney disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Urinary albumin excretion
time frame: 3 months
arm group label: very low calorie diet
arm group type: Experimental
intervention type: Other
intervention name: very low calorie diet
description: medically supervised diet
arm group label: very low calorie diet
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Diabetic Nephropathies