<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/NCT03019796</url>
  </required_header>
  <id_info>
    <org_study_id>0112001154 DEP2014-52930-R</org_study_id>
    <nct_id>NCT03019796</nct_id>
  </id_info>
  <brief_title>Exercise Training Effects on Metabolic Syndrome: Interactions With Medication</brief_title>
  <acronym>METSYND</acronym>
  <official_title>Effects of Exercise Training as a Non-pharmacological Treatment for Metabolic Syndrome and Its Interactions With Subjects Habitual Medications.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Castilla-La Mancha</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministerio de Economía y Competitividad, Spain</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Castilla-La Mancha</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To analyze the effects of different exercise training modalities (continuous, intervallic,&#xD;
      and resistance training) on cardiorespiratory and metabolic fitness of metabolic syndrome&#xD;
      patients when this training interacts with their habitual medication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: The purpose is to study in a group of adults with metabolic syndrome and obesity,&#xD;
      the effects of different modalities of exercise training on cardiorespiratory and metabolic&#xD;
      fitness. The main objective is to weight the effects of exercise training separately and in&#xD;
      conjunction with the subject's habitual pharmacological treatment to identify the best&#xD;
      combination of drug and exercise.&#xD;
&#xD;
      Methods and design: Randomized, pretest-posttest control group experimental design. Project&#xD;
      developed in a single center with the collaboration of the regional public health system.&#xD;
&#xD;
      Subjects: Will be referred by their primary care physicians to our study unit. Up to 40&#xD;
      subjects all of them with metabolic syndrome will be recruited (at least 20% women).&#xD;
&#xD;
      Measurements:&#xD;
&#xD;
        1. Specifically, the investigators, will study cardiovascular adaptations that increase, i)&#xD;
           maximal aerobic capacity measured by VO2max, ii) anaerobic and respiratory compensation&#xD;
           point ventilatory thresholds, iii) arterial stiffness, measured by pulse wave velocity&#xD;
           (SphygmoCor System), v) central and peripheral blood pressure, and iv) biological&#xD;
           markers of endothelial dysfunction using reactive hyperemia with a laser Doppler&#xD;
           fluxmeter in central and peripheral blood vessels.&#xD;
&#xD;
        2. The metabolic adaptations under study will include, i) insulin sensitivity by HOMA-IR,&#xD;
           ii) fat oxidation by indirect calorimetry&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2015</start_date>
  <completion_date type="Actual">August 2020</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.</time_frame>
    <description>Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.</time_frame>
    <description>Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Arterial Pressure</measure>
    <time_frame>Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.</time_frame>
    <description>Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximal Oxygen Consumption Rate During Exercise (VO2max).</measure>
    <time_frame>Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.</time_frame>
    <description>Index of cardiorespiratory fitness assessed during an incremental cycle-ergometer test using an indirect calorimetry system.&#xD;
Value is the difference between the placebo and antihypertensive medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal Rate of Fat Oxidation.</measure>
    <time_frame>Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.</time_frame>
    <description>Calculated in grams per min during the incremental cycloergometer test wih the use of indirect calorimetry system.&#xD;
Value is the difference between the placebo and antihypertensive medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Weight</measure>
    <time_frame>Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.</time_frame>
    <description>Nude body weight. Value is the difference between the placebo and antihypertensive medication.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Exercise Therapy</condition>
  <condition>Metabolic Syndrome X</condition>
  <condition>Cardiorespiratory Fitness</condition>
  <arm_group>
    <arm_group_label>PLACEBO FIRST THEN MEDICATED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects first receive the PLACEBO tablet during 72 hours (full withdrawal). After a week of taking again their medication (MEDICATION TRIAL), they will be tested again. This procedure will be repeated before and after 4 months of aerobic training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDICATED FIRST THEN PLACEBO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects first receive their antihypertensive MEDICATION tablet (habitual dose prescribed by their primary care doctors). After a week they will take a PLACEBO tablet for 72 hours and will be tested again. This procedure will be repeated before and after 4 months of aerobic training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MEDICATION AND EXERCISE TRAINING</intervention_name>
    <description>PARTICIPANTS WILL BE (IN A RANDOMIZED BLINDED FASHION) WITHDRAWN OF THEIR HYPERTENSIVE MEDICATION (I.E., PLACEBO) IN ONE OCCASION AND TESTED WITH THEIR MEDICATION IN ANOTHER, WITH A WEEK WASHOUT PERIOD.&#xD;
THIS TESTING WILL BE REPEATED AFER 4 MONTHS OF EXERCISE TRAINING (48 SESSIONS OF 43 MIN EACH ONE).</description>
    <arm_group_label>MEDICATED FIRST THEN PLACEBO</arm_group_label>
    <arm_group_label>PLACEBO FIRST THEN MEDICATED</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Metabolic syndrome patients diagnosed according to the International diabetes&#xD;
             federation consensus of 2009 (Alberti, et al., Circulation).&#xD;
&#xD;
          -  18-65 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Cardiovascular disease or musculo-skeletal that prevents them from being able to perform&#xD;
        intense exercise.&#xD;
&#xD;
          -  Respiratory failure&#xD;
&#xD;
          -  Patient ends&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo Mora-Rodriguez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Castilla-La Mancha</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Castilla-La Mancha (Exercise Physiology Lab)</name>
      <address>
        <city>Toledo</city>
        <zip>45071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Pallares JG, Mora-Rodriguez R. Cardiovascular Drift during Training for Fitness in Patients with Metabolic Syndrome. Med Sci Sports Exerc. 2017 Mar;49(3):518-526. doi: 10.1249/MSS.0000000000001139.</citation>
    <PMID>27787335</PMID>
  </reference>
  <reference>
    <citation>Ortega JF, Morales-Palomo F, Fernandez-Elias V, Hamouti N, Bernardo FJ, Martin-Doimeadios RC, Nelson RK, Horowitz JF, Mora-Rodriguez R. Dietary supplementation with omega-3 fatty acids and oleate enhances exercise training effects in patients with metabolic syndrome. Obesity (Silver Spring). 2016 Aug;24(8):1704-11. doi: 10.1002/oby.21552. Epub 2016 Jun 29.</citation>
    <PMID>27356240</PMID>
  </reference>
  <reference>
    <citation>Mora-Rodriguez R, Ortega JF, Guio de Prada V, Fernandez-Elias VE, Hamouti N, Morales-Palomo F, Martinez-Vizcaino V, Nelson RK. Effects of Simultaneous or Sequential Weight Loss Diet and Aerobic Interval Training on Metabolic Syndrome. Int J Sports Med. 2016 Apr;37(4):274-81. doi: 10.1055/s-0035-1564259. Epub 2015 Dec 14.</citation>
    <PMID>26667921</PMID>
  </reference>
  <reference>
    <citation>Ortega JF, Fernandez-Elias VE, Hamouti N, Pallares JG, Mora-Rodriguez R. Higher Insulin-sensitizing Response after Sprint Interval Compared to Continuous Exercise. Int J Sports Med. 2015 Mar;36(3):e4. doi: 10.1055/s-0035-1548800. Epub 2015 Mar 26. No abstract available.</citation>
    <PMID>25811624</PMID>
  </reference>
  <reference>
    <citation>Martinez-Vizcaino V, Sanchez-Lopez M, Notario-Pacheco B, Salcedo-Aguilar F, Solera-Martinez M, Franquelo-Morales P, Lopez-Martinez S, Garcia-Prieto JC, Arias-Palencia N, Torrijos-Nino C, Mora-Rodriguez R, Rodriguez-Artalejo F. Gender differences on effectiveness of a school-based physical activity intervention for reducing cardiometabolic risk: a cluster randomized trial. Int J Behav Nutr Phys Act. 2014 Dec 10;11:154. doi: 10.1186/s12966-014-0154-4.</citation>
    <PMID>25491026</PMID>
  </reference>
  <reference>
    <citation>Ortega JF, Fernandez-Elias VE, Hamouti N, Pallares JG, Mora-Rodriguez R. Higher insulin-sensitizing response after sprint interval compared to continuous exercise. Int J Sports Med. 2015 Mar;36(3):209-14. doi: 10.1055/s-0034-1389942. Epub 2014 Nov 6.</citation>
    <PMID>25376729</PMID>
  </reference>
  <reference>
    <citation>Ortega JF, Hamouti N, Fernandez-Elias VE, Mora-Rodriguez R. Comparison of glucose tolerance tests to detect the insulin sensitizing effects of a bout of continuous exercise. Appl Physiol Nutr Metab. 2014 Jul;39(7):787-92. doi: 10.1139/apnm-2013-0507. Epub 2014 Apr 11.</citation>
    <PMID>24971679</PMID>
  </reference>
  <reference>
    <citation>Ortega JF, Hamouti N, Fernandez-Elias VE, de Prada MV, Martinez-Vizcaino V, Mora-Rodriguez R. Metformin does not attenuate the acute insulin-sensitizing effect of a single bout of exercise in individuals with insulin resistance. Acta Diabetol. 2014 Oct;51(5):749-55. doi: 10.1007/s00592-014-0580-4. Epub 2014 Mar 29.</citation>
    <PMID>24682492</PMID>
  </reference>
  <reference>
    <citation>Mora-Rodriguez R, Ortega JF, Hamouti N, Fernandez-Elias VE, Canete Garcia-Prieto J, Guadalupe-Grau A, Saborido A, Martin-Garcia M, Guio de Prada V, Ara I, Martinez-Vizcaino V. Time-course effects of aerobic interval training and detraining in patients with metabolic syndrome. Nutr Metab Cardiovasc Dis. 2014 Jul;24(7):792-8. doi: 10.1016/j.numecd.2014.01.011. Epub 2014 Jan 29.</citation>
    <PMID>24656853</PMID>
  </reference>
  <reference>
    <citation>Diez-Fernandez A, Sanchez-Lopez M, Mora-Rodriguez R, Notario-Pacheco B, Torrijos-Nino C, Martinez-Vizcaino V. Obesity as a mediator of the influence of cardiorespiratory fitness on cardiometabolic risk: a mediation analysis. Diabetes Care. 2014;37(3):855-62. doi: 10.2337/dc13-0416. Epub 2013 Nov 6.</citation>
    <PMID>24198304</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 31, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>September 9, 2020</results_first_submitted>
  <results_first_submitted_qc>May 16, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 18, 2021</results_first_posted>
  <last_update_submitted>May 18, 2021</last_update_submitted>
  <last_update_submitted_qc>May 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>August 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03019796/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03019796/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 30, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03019796/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>All participants underwent four trials in a full cross-over randomized fashion. Subject tested before and after 4 months of training. At baseline subjects were tested on two occasions, one with and one without medication separated 72 hours. Post-training testing was similarly conducted with and without medication separated 72 hours.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>MEDICATED FIRST THEN PLACEBO</title>
          <description>Subjects will remain taking their habitual antihypertensive medication during this time. After this first test, they will receive placebo during 72 h and will be tested again.</description>
        </group>
        <group group_id="P2">
          <title>PLACEBO FIRST THEN MEDICATED</title>
          <description>Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo. Then their habitual medication will be restated and they will be tested again.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention Drug Tests</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Intervention Training (4 Months)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Third Intervention Drug Test</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline trial is the non-medicated, no-exercise</population>
      <group_list>
        <group group_id="B1">
          <title>PRE-POST TRAINING</title>
          <description>In this cross over design, participants will be tested PRE and POST 4 months of endurance training.&#xD;
They will be tested while taking their habitual medication on one occasion and in the other, the investigators will withhold their medication during 72 h to achieve 4 conditions:&#xD;
Untrained, no medicated.&#xD;
Untrained, medicated.&#xD;
a) Trained, no medicated. b) Trained, medicated.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Years old rounding up without desmo points BASED ON DATE OF BIRTH</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.7" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Dichotomic male or female as declared by the own subject</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <description>No classification by ethnicity was attempted. In Spain there are more than 25 recognized ethnicities. The program lists Latino or Hispanic as the only choice. However, our subjects do not fit into that category. There are not the product of the mix of races since the discovery and colonization of America starting in 1492 by Spaniards, Portugueses, and Italians. On the contrary, they are the ones that stayed in Europe. The simile will be to stablish that people in US should be named Anglosaxonis.</description>
          <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="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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>Race (NIH/OMB)</title>
          <description>In south Europe we have caucasians, asians, blacks, and gypsies as main races. Again, the program does not allow these choices.</description>
          <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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </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>
          <description>The basic region were we are recruiting subjects is south Europe (Spain).</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Systolic Blood Pressure</title>
        <description>Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.</description>
        <time_frame>Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.</time_frame>
        <population>All participants underwent four trials in a full cross-over randomized fashion</population>
        <group_list>
          <group group_id="O1">
            <title>MEDICATED</title>
            <description>Subjects will take their habitual dose of antihypertensive medication.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Systolic Blood Pressure</title>
          <description>Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.</description>
          <population>All participants underwent four trials in a full cross-over randomized fashion</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BEFORE TRAINING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126" spread="13"/>
                    <measurement group_id="O2" value="134" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFTER TRAINING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124" spread="13"/>
                    <measurement group_id="O2" value="133" spread="12"/>
                  </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_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.040</p_value>
            <method>ANOVA</method>
            <method_desc>repeated measures</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Diastolic Blood Pressure</title>
        <description>Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.</description>
        <time_frame>Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MEDICATED</title>
            <description>Subjects will be tested while taking their habitual antihypertensive medication.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Diastolic Blood Pressure</title>
          <description>Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BEFORE TRAINING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" spread="8"/>
                    <measurement group_id="O2" value="79" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFTER TRAINING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72" spread="7"/>
                    <measurement group_id="O2" value="77" spread="7"/>
                  </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_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.054</p_value>
            <method>ANOVA</method>
            <method_desc>repeated measures</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Arterial Pressure</title>
        <description>Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.</description>
        <time_frame>Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MEDICATED</title>
            <description>Subjects will be tested while taking their habitual antihypertensive medication.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Arterial Pressure</title>
          <description>Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.</description>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BEFORE TRAINING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92" spread="9"/>
                    <measurement group_id="O2" value="97" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFTER TRAINING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89" spread="8"/>
                    <measurement group_id="O2" value="96" spread="8"/>
                  </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_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.040</p_value>
            <method>ANOVA</method>
            <method_desc>REPEATED MEASURES</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximal Oxygen Consumption Rate During Exercise (VO2max).</title>
        <description>Index of cardiorespiratory fitness assessed during an incremental cycle-ergometer test using an indirect calorimetry system.&#xD;
Value is the difference between the placebo and antihypertensive medication.</description>
        <time_frame>Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MEDICATED</title>
            <description>Subjects will be tested while taking their habitual antihypertensive medication.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximal Oxygen Consumption Rate During Exercise (VO2max).</title>
          <description>Index of cardiorespiratory fitness assessed during an incremental cycle-ergometer test using an indirect calorimetry system.&#xD;
Value is the difference between the placebo and antihypertensive medication.</description>
          <units>Liters of O2/kg weight/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BEFORE TRAINING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.26" spread="0.58"/>
                    <measurement group_id="O2" value="2.26" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFTER TRAINING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.49" spread="0.55"/>
                    <measurement group_id="O2" value="2.49" spread="0.55"/>
                  </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_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.321</p_value>
            <method>ANOVA</method>
            <method_desc>REPEATED MEASURES</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximal Rate of Fat Oxidation.</title>
        <description>Calculated in grams per min during the incremental cycloergometer test wih the use of indirect calorimetry system.&#xD;
Value is the difference between the placebo and antihypertensive medication.</description>
        <time_frame>Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MEDICATED</title>
            <description>Subjects will be tested while taking their habitual antihypertensive medication.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximal Rate of Fat Oxidation.</title>
          <description>Calculated in grams per min during the incremental cycloergometer test wih the use of indirect calorimetry system.&#xD;
Value is the difference between the placebo and antihypertensive medication.</description>
          <units>grams/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BEFORE TRAINING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" spread="0.10"/>
                    <measurement group_id="O2" value="0.24" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFTER TRAINING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" spread="0.15"/>
                    <measurement group_id="O2" value="0.28" spread="0.15"/>
                  </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>0.401</p_value>
            <method>ANOVA</method>
            <method_desc>REPEATED MEASURES</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Body Weight</title>
        <description>Nude body weight. Value is the difference between the placebo and antihypertensive medication.</description>
        <time_frame>Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MEDICATED</title>
            <description>Subjects will be tested while taking their habitual antihypertensive medication.</description>
          </group>
          <group group_id="O2">
            <title>PLACEBO</title>
            <description>Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Body Weight</title>
          <description>Nude body weight. Value is the difference between the placebo and antihypertensive medication.</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BEFORE TRAINING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.1" spread="13.6"/>
                    <measurement group_id="O2" value="92.5" spread="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AFTER TRAINING</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0" spread="13.2"/>
                    <measurement group_id="O2" value="90.8" spread="13.4"/>
                  </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>0.021</p_value>
            <method>ANOVA</method>
            <method_desc>REPEATED MEASURES</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 months of the intervention</time_frame>
      <desc>No adverse events were recorded</desc>
      <group_list>
        <group group_id="E1">
          <title>MEDICATED vs NO MEDICATED BEFORE TRAINING</title>
          <description>Subjects will be tested twice one taking their habitual dose of medication, and in the other, the investigators will withhold their medication during 72 h.&#xD;
Untrained, no medicated.&#xD;
Untrained, medicated.</description>
        </group>
        <group group_id="E2">
          <title>MEDICATED vs NO MEDICATED AFTER EXERCISE TRAINING</title>
          <description>After 4 months of endurance training subjects will be tested twice one taking their habitual dose of medication, and in the other, the investigators will withhold their medication during 72 h.&#xD;
c) Trained, no medicated. d) Trained, medicated.</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="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </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="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
              </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>Proffessor</name_or_title>
      <organization>University of Castilla-La Mancha</organization>
      <phone>925268800</phone>
      <email>ricardo.mora@uclm.es</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/NCT03019796
org study id: 0112001154 DEP2014-52930-R
nct id: NCT03019796
lead sponsor: 
collaborator: 
has dmc: Yes
To analyze the effects of different exercise training modalities (continuous, intervallic,
      and resistance training) on cardiorespiratory and metabolic fitness of metabolic syndrome
      patients when this training interacts with their habitual medication.
Objective: The purpose is to study in a group of adults with metabolic syndrome and obesity,
      the effects of different modalities of exercise training on cardiorespiratory and metabolic
      fitness. The main objective is to weight the effects of exercise training separately and in
      conjunction with the subject's habitual pharmacological treatment to identify the best
      combination of drug and exercise.

      Methods and design: Randomized, pretest-posttest control group experimental design. Project
      developed in a single center with the collaboration of the regional public health system.

      Subjects: Will be referred by their primary care physicians to our study unit. Up to 40
      subjects all of them with metabolic syndrome will be recruited (at least 20% women).

      Measurements:

        1. Specifically, the investigators, will study cardiovascular adaptations that increase, i)
           maximal aerobic capacity measured by VO2max, ii) anaerobic and respiratory compensation
           point ventilatory thresholds, iii) arterial stiffness, measured by pulse wave velocity
           (SphygmoCor System), v) central and peripheral blood pressure, and iv) biological
           markers of endothelial dysfunction using reactive hyperemia with a laser Doppler
           fluxmeter in central and peripheral blood vessels.

        2. The metabolic adaptations under study will include, i) insulin sensitivity by HOMA-IR,
           ii) fat oxidation by indirect calorimetry
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Systolic Blood Pressure
time frame: Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.
description: Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.
measure: Diastolic Blood Pressure
time frame: Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.
description: Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.
measure: Mean Arterial Pressure
time frame: Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.
description: Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.
measure: Maximal Oxygen Consumption Rate During Exercise (VO2max).
time frame: Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.
description: Index of cardiorespiratory fitness assessed during an incremental cycle-ergometer test using an indirect calorimetry system.
Value is the difference between the placebo and antihypertensive medication.
measure: Maximal Rate of Fat Oxidation.
time frame: Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.
description: Calculated in grams per min during the incremental cycloergometer test wih the use of indirect calorimetry system.
Value is the difference between the placebo and antihypertensive medication.
measure: Body Weight
time frame: Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.
description: Nude body weight. Value is the difference between the placebo and antihypertensive medication.
arm group label: PLACEBO FIRST THEN MEDICATED
arm group type: Experimental
description: Subjects first receive the PLACEBO tablet during 72 hours (full withdrawal). After a week of taking again their medication (MEDICATION TRIAL), they will be tested again. This procedure will be repeated before and after 4 months of aerobic training.
arm group label: MEDICATED FIRST THEN PLACEBO
arm group type: Experimental
description: Subjects first receive their antihypertensive MEDICATION tablet (habitual dose prescribed by their primary care doctors). After a week they will take a PLACEBO tablet for 72 hours and will be tested again. This procedure will be repeated before and after 4 months of aerobic training.
intervention type: Drug
intervention name: MEDICATION AND EXERCISE TRAINING
description: PARTICIPANTS WILL BE (IN A RANDOMIZED BLINDED FASHION) WITHDRAWN OF THEIR HYPERTENSIVE MEDICATION (I.E., PLACEBO) IN ONE OCCASION AND TESTED WITH THEIR MEDICATION IN ANOTHER, WITH A WEEK WASHOUT PERIOD.
THIS TESTING WILL BE REPEATED AFER 4 MONTHS OF EXERCISE TRAINING (48 SESSIONS OF 43 MIN EACH ONE).
arm group label: MEDICATED FIRST THEN PLACEBO
arm group label: PLACEBO FIRST THEN MEDICATED
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ricardo Mora-Rodriguez, PhD
role: Principal Investigator
affiliation: University of Castilla-La Mancha
facility: 
country: Spain
citation: Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Pallares JG, Mora-Rodriguez R. Cardiovascular Drift during Training for Fitness in Patients with Metabolic Syndrome. Med Sci Sports Exerc. 2017 Mar;49(3):518-526. doi: 10.1249/MSS.0000000000001139.
PMID: 27787335
citation: Ortega JF, Morales-Palomo F, Fernandez-Elias V, Hamouti N, Bernardo FJ, Martin-Doimeadios RC, Nelson RK, Horowitz JF, Mora-Rodriguez R. Dietary supplementation with omega-3 fatty acids and oleate enhances exercise training effects in patients with metabolic syndrome. Obesity (Silver Spring). 2016 Aug;24(8):1704-11. doi: 10.1002/oby.21552. Epub 2016 Jun 29.
PMID: 27356240
citation: Mora-Rodriguez R, Ortega JF, Guio de Prada V, Fernandez-Elias VE, Hamouti N, Morales-Palomo F, Martinez-Vizcaino V, Nelson RK. Effects of Simultaneous or Sequential Weight Loss Diet and Aerobic Interval Training on Metabolic Syndrome. Int J Sports Med. 2016 Apr;37(4):274-81. doi: 10.1055/s-0035-1564259. Epub 2015 Dec 14.
PMID: 26667921
citation: Ortega JF, Fernandez-Elias VE, Hamouti N, Pallares JG, Mora-Rodriguez R. Higher Insulin-sensitizing Response after Sprint Interval Compared to Continuous Exercise. Int J Sports Med. 2015 Mar;36(3):e4. doi: 10.1055/s-0035-1548800. Epub 2015 Mar 26. No abstract available.
PMID: 25811624
citation: Martinez-Vizcaino V, Sanchez-Lopez M, Notario-Pacheco B, Salcedo-Aguilar F, Solera-Martinez M, Franquelo-Morales P, Lopez-Martinez S, Garcia-Prieto JC, Arias-Palencia N, Torrijos-Nino C, Mora-Rodriguez R, Rodriguez-Artalejo F. Gender differences on effectiveness of a school-based physical activity intervention for reducing cardiometabolic risk: a cluster randomized trial. Int J Behav Nutr Phys Act. 2014 Dec 10;11:154. doi: 10.1186/s12966-014-0154-4.
PMID: 25491026
citation: Ortega JF, Fernandez-Elias VE, Hamouti N, Pallares JG, Mora-Rodriguez R. Higher insulin-sensitizing response after sprint interval compared to continuous exercise. Int J Sports Med. 2015 Mar;36(3):209-14. doi: 10.1055/s-0034-1389942. Epub 2014 Nov 6.
PMID: 25376729
citation: Ortega JF, Hamouti N, Fernandez-Elias VE, Mora-Rodriguez R. Comparison of glucose tolerance tests to detect the insulin sensitizing effects of a bout of continuous exercise. Appl Physiol Nutr Metab. 2014 Jul;39(7):787-92. doi: 10.1139/apnm-2013-0507. Epub 2014 Apr 11.
PMID: 24971679
citation: Ortega JF, Hamouti N, Fernandez-Elias VE, de Prada MV, Martinez-Vizcaino V, Mora-Rodriguez R. Metformin does not attenuate the acute insulin-sensitizing effect of a single bout of exercise in individuals with insulin resistance. Acta Diabetol. 2014 Oct;51(5):749-55. doi: 10.1007/s00592-014-0580-4. Epub 2014 Mar 29.
PMID: 24682492
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PMID: 24656853
citation: Diez-Fernandez A, Sanchez-Lopez M, Mora-Rodriguez R, Notario-Pacheco B, Torrijos-Nino C, Martinez-Vizcaino V. Obesity as a mediator of the influence of cardiorespiratory fitness on cardiometabolic risk: a mediation analysis. Diabetes Care. 2014;37(3):855-62. doi: 10.2337/dc13-0416. Epub 2013 Nov 6.
PMID: 24198304
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome
sharing ipd: No
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