<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/NCT01700530</url>
  </required_header>
  <id_info>
    <org_study_id>09CRP2260136</org_study_id>
    <nct_id>NCT01700530</nct_id>
  </id_info>
  <brief_title>Exercise, Statins, and the Metabolic Syndrome</brief_title>
  <official_title>Exercise, Statins, and the Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Heart Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Here we tested if statins or exercise plus statins had a greater capacity to lower metabolic&#xD;
      syndrome risk factors in sedentary individuals with at least 2 metabolic syndrome risk&#xD;
      factors. We also examined if statins impacted exercise response for mitochondrial content in&#xD;
      muscle or aerobic fitness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES: Determine if simvastatin impairs exercise training adaptations.&#xD;
&#xD;
      BACKGROUND: Statins are commonly prescribed in combination with therapeutic lifestyle&#xD;
      changes, including exercise, to reduce cardiovascular disease risk in patients with the&#xD;
      metabolic syndrome. Statin use has been linked to skeletal muscle myopathy and impaired&#xD;
      mitochondrial function, but it is unclear whether statin use alters adaptations to exercise&#xD;
      training.&#xD;
&#xD;
      METHODS: We examined the effects of simvastatin on changes in cardiorespiratory fitness and&#xD;
      skeletal muscle mitochondrial content in response to aerobic exercise training. Sedentary&#xD;
      overweight or obese adults with at least 2 metabolic syndrome risk factors (defined according&#xD;
      to National Cholesterol Education Panel Adult Treatment Panel III criteria) were randomized&#xD;
      to 12 weeks of aerobic exercise training or to exercise in combination with simvastatin (40&#xD;
      mg per day). The primary outcomes were cardiorespiratory fitness and skeletal muscle (vastus&#xD;
      lateralis) mitochondrial content (citrate synthase enzyme activity).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2007</start_date>
  <completion_date type="Actual">May 2011</completion_date>
  <primary_completion_date type="Actual">May 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% Change in VO2max (Fitness)</measure>
    <time_frame>Change from Baseline to 12 weeks</time_frame>
    <description>% change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)</measure>
    <time_frame>12 weeks</time_frame>
    <description>% change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Obese</condition>
  <condition>Sedentary</condition>
  <arm_group>
    <arm_group_label>Statin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Statins (40mg/day)for an average of 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 weeks of exercise training (5 days a week for 45-50 min a session)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Statins + Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Statin</intervention_name>
    <description>Statins (40mg/day)for 12 weeks</description>
    <arm_group_label>Statin</arm_group_label>
    <other_name>simvastatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise only</intervention_name>
    <description>12 weeks of exercise training (5 days a week for 45-50 min a session)</description>
    <arm_group_label>Exercise only</arm_group_label>
    <other_name>Physical activity</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Statins + Exercise</intervention_name>
    <description>Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks</description>
    <arm_group_label>Statins + Exercise</arm_group_label>
    <other_name>Statins + Physical Activity</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sedentary metabolic syndrome subjects will be 25-59 y of age&#xD;
&#xD;
          -  overweight to Class I or II obese (BMI 25-39 kg/m2) men and women&#xD;
&#xD;
          -  2 of 4 other characteristics of the metabolic syndrome including fasting glucose of&#xD;
             100 to 125 mg/dl; waist circumference greater than 102 cm in men and 88 cm in women,&#xD;
             serum triglyceride concentration greater than 150 mg/dl, HDL-C concentrations less&#xD;
             than 40 mg/dl in men and 50 mg/dl in women, and blood pressure greater than 130/85&#xD;
             mmHG&#xD;
&#xD;
          -  Women must be taking birth control or be postmenopausal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed cardiovascular disease or diabetes or disease&#xD;
&#xD;
          -  Symptoms that could alter their ability to perform exercise&#xD;
&#xD;
          -  Fasting blood glucose of greater than 126 mg/dl&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Taking any medications or supplements (e.g., statins, fibrates, metformin,&#xD;
             thiazolidenediones, anti-hypertensives (ACE-inhibitors and angiotensin blockers) which&#xD;
             could affect blood lipids or insulin sensitivity.&#xD;
&#xD;
          -  Women who are pregnant or plan to become pregnant during the duration of the study&#xD;
&#xD;
          -  Individuals exercising regularly (more than one 30 min session per week)&#xD;
&#xD;
          -  Individuals with an orthopedic limitations for walking.&#xD;
&#xD;
          -  Report any allergies to the medications (statins, lidocaine)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John P Thyfault, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri-Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>October 14, 2014</results_first_submitted>
  <results_first_submitted_qc>January 4, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 5, 2016</results_first_posted>
  <last_update_submitted>January 4, 2016</last_update_submitted>
  <last_update_submitted_qc>January 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mitochondria</keyword>
  <keyword>fitness</keyword>
  <keyword>statins</keyword>
  <keyword>cholesterol</keyword>
  <keyword>metabolic syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simvastatin</mesh_term>
    <mesh_term>Hydroxymethylglutaryl-CoA Reductase Inhibitors</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>If meeting qualifications after initial phone screening, subject consented followed by another round of screening to determine if they had 2/5 risk factors or not which eliminated many subjects. Thus the difference between the 121 subjects reported for who signed consents and the 50 who entered the participant flow module.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Statin</title>
          <description>Statins (40mg/day)for an average of 12 weeks&#xD;
Statin: Statins (40mg/day)for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>Exercise Only</title>
          <description>12 weeks of exercise training (5 days a week for 45-50 min a session)&#xD;
Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)</description>
        </group>
        <group group_id="P3">
          <title>Statins + Exercise</title>
          <description>Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks&#xD;
Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Sedentary, obese, 2/5 metabolic syndrome risk factors, males and females</population>
      <group_list>
        <group group_id="B1">
          <title>Statin</title>
          <description>Statins (40mg/day)for an average of 12 weeks&#xD;
Statin: Statins (40mg/day)for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>Exercise Only</title>
          <description>12 weeks of exercise training (5 days a week for 45-50 min a session)&#xD;
Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)</description>
        </group>
        <group group_id="B3">
          <title>Statins + Exercise</title>
          <description>Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks&#xD;
Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="21"/>
            <count group_id="B3" value="20"/>
            <count group_id="B4" value="50"/>
          </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="44" spread="10"/>
                    <measurement group_id="B2" value="44" spread="12"/>
                    <measurement group_id="B3" value="43" spread="9"/>
                    <measurement group_id="B4" value="44" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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="4"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="22"/>
                  </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="9"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>% Change in VO2max (Fitness)</title>
        <description>% change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max</description>
        <time_frame>Change from Baseline to 12 weeks</time_frame>
        <population>Statins blocked exercise induced change in fitness</population>
        <group_list>
          <group group_id="O1">
            <title>Statin</title>
            <description>Statins (40mg/day)for an average of 12 weeks&#xD;
Statin: Statins (40mg/day)for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Exercise Only</title>
            <description>12 weeks of exercise training (5 days a week for 45-50 min a session)&#xD;
Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)</description>
          </group>
          <group group_id="O3">
            <title>Statins + Exercise</title>
            <description>Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks&#xD;
Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>% Change in VO2max (Fitness)</title>
          <description>% change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max</description>
          <population>Statins blocked exercise induced change in fitness</population>
          <units>percentage change of VO2max</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="6"/>
                    <measurement group_id="O2" value="10" spread="5"/>
                    <measurement group_id="O3" value="1.5" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)</title>
        <description>% change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Statin</title>
            <description>Statins (40mg/day)for an average of 12 weeks&#xD;
Statin: Statins (40mg/day)for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Exercise Only</title>
            <description>12 weeks of exercise training (5 days a week for 45-50 min a session)&#xD;
Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)</description>
          </group>
          <group group_id="O3">
            <title>Statins + Exercise</title>
            <description>Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks&#xD;
Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)</title>
          <description>% change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="10"/>
                    <measurement group_id="O2" value="13" spread="7"/>
                    <measurement group_id="O3" value="-4.5" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Statin</title>
          <description>Statins (40mg/day)for an average of 12 weeks&#xD;
Statin: Statins (40mg/day)for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>Exercise Only</title>
          <description>12 weeks of exercise training (5 days a week for 45-50 min a session)&#xD;
Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)</description>
        </group>
        <group group_id="E3">
          <title>Statins + Exercise</title>
          <description>Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks&#xD;
Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
              </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="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
              </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>John P. Thyfault, PhD</name_or_title>
      <organization>University of Missouri</organization>
      <phone>573-874-9728</phone>
      <email>thyfaultj@missouri.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/NCT01700530
org study id: 09CRP2260136
nct id: NCT01700530
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Here we tested if statins or exercise plus statins had a greater capacity to lower metabolic
      syndrome risk factors in sedentary individuals with at least 2 metabolic syndrome risk
      factors. We also examined if statins impacted exercise response for mitochondrial content in
      muscle or aerobic fitness.
OBJECTIVES: Determine if simvastatin impairs exercise training adaptations.

      BACKGROUND: Statins are commonly prescribed in combination with therapeutic lifestyle
      changes, including exercise, to reduce cardiovascular disease risk in patients with the
      metabolic syndrome. Statin use has been linked to skeletal muscle myopathy and impaired
      mitochondrial function, but it is unclear whether statin use alters adaptations to exercise
      training.

      METHODS: We examined the effects of simvastatin on changes in cardiorespiratory fitness and
      skeletal muscle mitochondrial content in response to aerobic exercise training. Sedentary
      overweight or obese adults with at least 2 metabolic syndrome risk factors (defined according
      to National Cholesterol Education Panel Adult Treatment Panel III criteria) were randomized
      to 12 weeks of aerobic exercise training or to exercise in combination with simvastatin (40
      mg per day). The primary outcomes were cardiorespiratory fitness and skeletal muscle (vastus
      lateralis) mitochondrial content (citrate synthase enzyme activity).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: % Change in VO2max (Fitness)
time frame: Change from Baseline to 12 weeks
description: % change in fitness between baseline and after 12 weeks of treatment will be assessed by VO2max
measure: Skeletal Muscle Mitochondrial Content (Citrate Synthase Enzyme Activity)
time frame: 12 weeks
description: % change in skeletal muscle mitochondrial content (measured by citrate synthase enzyme activity) from pre to post intervention
arm group label: Statin
arm group type: Experimental
description: Statins (40mg/day)for an average of 12 weeks
arm group label: Exercise only
arm group type: Experimental
description: 12 weeks of exercise training (5 days a week for 45-50 min a session)
arm group label: Statins + Exercise
arm group type: Active Comparator
description: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks
intervention type: Drug
intervention name: Statin
description: Statins (40mg/day)for 12 weeks
arm group label: Statin
other name: simvastatin
intervention type: Other
intervention name: Exercise only
description: 12 weeks of exercise training (5 days a week for 45-50 min a session)
arm group label: Exercise only
other name: Physical activity
intervention type: Other
intervention name: Statins + Exercise
description: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks
arm group label: Statins + Exercise
other name: Statins + Physical Activity
criteria: 
gender: All
minimum age: 25 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John P Thyfault, PhD
role: Principal Investigator
affiliation: University of Missouri-Columbia
facility: 
country: United States
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome
mesh term: Simvastatin
mesh term: Hydroxymethylglutaryl-CoA Reductase Inhibitors
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 