<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/NCT03829514</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00079289</org_study_id>
    <nct_id>NCT03829514</nct_id>
  </id_info>
  <brief_title>Fenofibrate in Type 2 Diabetes</brief_title>
  <official_title>Fenofibrate in Type 2 Diabetes- Novel Biomarkers and Mechanisms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetic complications affecting the eyes, kidneys, and nerves are difficult to arrest once&#xD;
      in progress. Recent evidence that fenofibrate confers a robust yet unexpected benefit in&#xD;
      diabetic retinopathy offers an important translational research opportunity. The&#xD;
      investigator's global proteomic study will provide new clues as to how fenofibrate protects&#xD;
      vulnerable tissues, and will spur discovery of targets for new therapeutic interventions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Actual">March 4, 2020</completion_date>
  <primary_completion_date type="Actual">March 4, 2020</primary_completion_date>
  <phase>Phase 4</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Individual Plasma Proteins That Changed From Baseline to End-point Based on Limma T-Test of Protein Abundance as Determined by Proteomic Analysis Via Liquid Chromatography-mass Spectrometry</measure>
    <time_frame>Six weeks, from baseline visit to study completion visit</time_frame>
    <description>Protein exclusive intensity values (counts/second) were normalized using cyclic loess normalization. Mean protein abundance as determined by the intensity for each protein was determined. 95% confidence intervals were calculated as a measure of dispersion. Paired means were compared using a Limma T-test and the p-value was adjusted for multiple comparisons using the Benjamini-Hochberg method. Mean Log2 Fold Change was calculated for each protein compared between 6 weeks and baseline. The number of proteins that changed between 6 weeks and baseline was zero.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Diabetes Mellitus, Type II</condition>
  <arm_group>
    <arm_group_label>Fenofibrate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm. Participants will take study medication</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fenofibrate</intervention_name>
    <description>40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides &gt;150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.</description>
    <arm_group_label>Fenofibrate</arm_group_label>
    <other_name>Trilipix</other_name>
    <other_name>Triglide</other_name>
    <other_name>Antara</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes of at least one year's duration; stable glycemic control (no more than&#xD;
             1.0% change in HbA1c in the previous six months, but no limit on HbA1c)&#xD;
&#xD;
          -  Triglycerides &gt;150 mg/dL (in the previous six months)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous use of Fenofibrate or other fibrates&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Recent cardiac event or congestive heart failure&#xD;
&#xD;
          -  Active liver disease&#xD;
&#xD;
          -  Significant renal impairment (serum creatinine &gt; 2mg/dl)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <results_first_submitted>September 8, 2021</results_first_submitted>
  <results_first_submitted_qc>January 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2022</results_first_posted>
  <disposition_first_submitted>February 17, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>January 11, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 8, 2022</disposition_first_posted>
  <last_update_submitted>January 11, 2022</last_update_submitted>
  <last_update_submitted_qc>January 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Timothy Lyons</investigator_full_name>
    <investigator_title>Professor and Chief, Division of Endocrinology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fenofibrate</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03829514/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fenofibrate</title>
          <description>Single arm. Participants will take study medication&#xD;
Fenofibrate: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides &gt;150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fenofibrate</title>
          <description>Single arm. Participants will take study medication&#xD;
Fenofibrate: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides &gt;150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of proteins and their relative abundance</title>
          <units>proteins</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="667"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Individual Plasma Proteins That Changed From Baseline to End-point Based on Limma T-Test of Protein Abundance as Determined by Proteomic Analysis Via Liquid Chromatography-mass Spectrometry</title>
        <description>Protein exclusive intensity values (counts/second) were normalized using cyclic loess normalization. Mean protein abundance as determined by the intensity for each protein was determined. 95% confidence intervals were calculated as a measure of dispersion. Paired means were compared using a Limma T-test and the p-value was adjusted for multiple comparisons using the Benjamini-Hochberg method. Mean Log2 Fold Change was calculated for each protein compared between 6 weeks and baseline. The number of proteins that changed between 6 weeks and baseline was zero.</description>
        <time_frame>Six weeks, from baseline visit to study completion visit</time_frame>
        <population>One participant sample lacked quantity to test.</population>
        <group_list>
          <group group_id="O1">
            <title>Fenofibrate</title>
            <description>Single arm. Participants will take study medication&#xD;
Fenofibrate: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides &gt;150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Individual Plasma Proteins That Changed From Baseline to End-point Based on Limma T-Test of Protein Abundance as Determined by Proteomic Analysis Via Liquid Chromatography-mass Spectrometry</title>
          <description>Protein exclusive intensity values (counts/second) were normalized using cyclic loess normalization. Mean protein abundance as determined by the intensity for each protein was determined. 95% confidence intervals were calculated as a measure of dispersion. Paired means were compared using a Limma T-test and the p-value was adjusted for multiple comparisons using the Benjamini-Hochberg method. Mean Log2 Fold Change was calculated for each protein compared between 6 weeks and baseline. The number of proteins that changed between 6 weeks and baseline was zero.</description>
          <population>One participant sample lacked quantity to test.</population>
          <units>Proteins</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>proteins</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>proteins</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="667"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-2" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.05</p_value>
            <method>t-test, 2 sided</method>
            <method_desc>Signal intensity data were loess normalized and normalized data were used to perform a limma t-test with empirical Bayes smoothing to standard errors</method_desc>
            <other_analysis_desc>Proteins were identified and quantified using EncyclopeDIA and visualized with Scaffold DIA using 1% false discovery thresholds at both the protein and peptide level. Protein exclusive intensity values were assessed for quality using an in-house ProteiNorm app, a tool for systematic evaluation of normalization methods, imputation of missing values and comparisons of multiple differential abundance methods . Cyclic loess normalization. The normalized data were used to perform statistical analysis using linear models for microarray data (limma) with empirical Bayes (eBayes) smoothing to the standard errors. Proteins with p-value &lt; 0.05 were considered significant.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>time each participate was receiving intervention; baseline and study completion, 6 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Fenofibrate</title>
          <description>Single arm. Participants will take study medication&#xD;
Fenofibrate: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides &gt;150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Misti Leyva</name_or_title>
      <organization>Medical University of South Carolina</organization>
      <phone>endo office</phone>
      <email>leyva@musc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03829514
org study id: Pro00079289
nct id: NCT03829514
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Diabetic complications affecting the eyes, kidneys, and nerves are difficult to arrest once
      in progress. Recent evidence that fenofibrate confers a robust yet unexpected benefit in
      diabetic retinopathy offers an important translational research opportunity. The
      investigator's global proteomic study will provide new clues as to how fenofibrate protects
      vulnerable tissues, and will spur discovery of targets for new therapeutic interventions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Number of Individual Plasma Proteins That Changed From Baseline to End-point Based on Limma T-Test of Protein Abundance as Determined by Proteomic Analysis Via Liquid Chromatography-mass Spectrometry
time frame: Six weeks, from baseline visit to study completion visit
description: Protein exclusive intensity values (counts/second) were normalized using cyclic loess normalization. Mean protein abundance as determined by the intensity for each protein was determined. 95% confidence intervals were calculated as a measure of dispersion. Paired means were compared using a Limma T-test and the p-value was adjusted for multiple comparisons using the Benjamini-Hochberg method. Mean Log2 Fold Change was calculated for each protein compared between 6 weeks and baseline. The number of proteins that changed between 6 weeks and baseline was zero.
arm group label: Fenofibrate
arm group type: Experimental
description: Single arm. Participants will take study medication
intervention type: Drug
intervention name: Fenofibrate
description: 40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides >150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.
arm group label: Fenofibrate
other name: Trilipix
other name: Triglide
other name: Antara
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Timothy Lyons
investigator title: Professor and Chief, Division of Endocrinology
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Fenofibrate
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 