<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/NCT03808090</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-130502007</org_study_id>
    <secondary_id>1K08DK115833-01A1</secondary_id>
    <nct_id>NCT03808090</nct_id>
  </id_info>
  <brief_title>Obesity and Endogenous Oxalate Synthesis</brief_title>
  <official_title>Obesity and Endogenous Oxalate Synthesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this proposal is to determine the contribution and significance of obesity to&#xD;
      urinary oxalate excretion and thus calcium oxalate kidney stone disease. Successful&#xD;
      completion of the study will provide insight into the link between obesity and kidney stone&#xD;
      disease and should identify future strategies to treat this disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Actual">July 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary oxalate excretion</measure>
    <time_frame>Baseline through 2 months</time_frame>
    <description>Urinary oxalate excretion from 24 hour urine collections will be reported as mg/day</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Obesity</condition>
  <condition>Kidney Stone</condition>
  <arm_group>
    <arm_group_label>Normal Individuals</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Normal individuals: no prior history of KS, no obesity, no diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calcium Oxalate Kidney Stone Formers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those individuals that have a high propensity to form calcium oxalate kidney stones</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 Diabetes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those individuals that have been diagnosed with type 2 diabetes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 diabetic kidney stone formers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those individuals that have been diagnosed with type 2 diabetes and kidney stones.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Individuals</intervention_name>
    <description>Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver</description>
    <arm_group_label>Normal Individuals</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Calcium Oxalate Kidney Stone Formers</intervention_name>
    <description>Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver</description>
    <arm_group_label>Calcium Oxalate Kidney Stone Formers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Type 2 Diabetes</intervention_name>
    <description>Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver</description>
    <arm_group_label>Type 2 Diabetes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Type 2 diabetic kidney stone formers</intervention_name>
    <description>Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver</description>
    <arm_group_label>Type 2 diabetic kidney stone formers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI) &lt; 30&#xD;
&#xD;
          -  Calcium oxalate stone formers with passage or removal of a kidney stone containing &gt;&#xD;
             50% calcium oxalate&#xD;
&#xD;
          -  Type 2 Diabetics with fasting glucose &gt; 126 mg/dL or hemoglobin A1c greater than or&#xD;
             equal to 6.5%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any disease that will affect the urinary excretion of oxalate, calcium or another ion&#xD;
             that will compromise the interpretation of results.&#xD;
&#xD;
          -  Abnormal urine chemistries or blood metabolic profiles&#xD;
&#xD;
          -  A glomerular filtration rate (GFR) or estimated GFR &lt; 60 mls/min&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt; 32&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyle D Wood, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>July 19, 2023</last_update_submitted>
  <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Kyle D. Wood</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>oxalate</keyword>
  <keyword>obesity</keyword>
  <keyword>kidney stones</keyword>
  <keyword>diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_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/NCT03808090
org study id: IRB-130502007
secondary id: 1K08DK115833-01A1
nct id: NCT03808090
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of this proposal is to determine the contribution and significance of obesity to
      urinary oxalate excretion and thus calcium oxalate kidney stone disease. Successful
      completion of the study will provide insight into the link between obesity and kidney stone
      disease and should identify future strategies to treat this disease.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Urinary oxalate excretion
time frame: Baseline through 2 months
description: Urinary oxalate excretion from 24 hour urine collections will be reported as mg/day
arm group label: Normal Individuals
arm group type: Experimental
description: Normal individuals: no prior history of KS, no obesity, no diabetes
arm group label: Calcium Oxalate Kidney Stone Formers
arm group type: Experimental
description: Those individuals that have a high propensity to form calcium oxalate kidney stones
arm group label: Type 2 Diabetes
arm group type: Experimental
description: Those individuals that have been diagnosed with type 2 diabetes
arm group label: Type 2 diabetic kidney stone formers
arm group type: Experimental
description: Those individuals that have been diagnosed with type 2 diabetes and kidney stones.
intervention type: Other
intervention name: Normal Individuals
description: Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
arm group label: Normal Individuals
intervention type: Other
intervention name: Calcium Oxalate Kidney Stone Formers
description: Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
arm group label: Calcium Oxalate Kidney Stone Formers
intervention type: Other
intervention name: Type 2 Diabetes
description: Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
arm group label: Type 2 Diabetes
intervention type: Other
intervention name: Type 2 diabetic kidney stone formers
description: Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
arm group label: Type 2 diabetic kidney stone formers
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kyle D Wood, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Kyle D. Wood
investigator title: Principal Investigator
mesh term: Kidney Calculi
mesh term: Nephrolithiasis
mesh term: Obesity
mesh term: Calcium
sharing ipd: No