<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/NCT03750695</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00105627</org_study_id>
    <nct_id>NCT03750695</nct_id>
  </id_info>
  <brief_title>Acute Exercise Effects in Obese Pregnancy</brief_title>
  <official_title>Acute Effects of Aerobic and Resistance Exercise on Maternal Glucose Metabolism and Vascular Function in Obese Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obesity before and during pregnancy is associated with a higher risk for a number of&#xD;
      obstetric and metabolic complications in women and their offspring. Of particular importance,&#xD;
      obese women have a higher risk of developing gestational diabetes and preeclampsia. In&#xD;
      addition, obese women have larger offspring who have a higher risk for the development of&#xD;
      obesity and diabetes; both largely attributed to higher maternal glycemia and glucose&#xD;
      intolerance during pregnancy. Thus, identifying rehabilitative interventions that improve&#xD;
      maternal and offspring metabolic and cardiovascular health in obese pregnancy are critical&#xD;
      and have immediate and generational impact. Resistance and aerobic exercise training is a&#xD;
      clinical staple for improving musculoskeletal, metabolic and cardiovascular health in&#xD;
      non-gravid adolescents and adults with obesity however little is known regarding the effects&#xD;
      of exercise during obese pregnancy. This study proposes to collect preliminary data on the&#xD;
      independent effects of acute aerobic and resistance rehabilitative exercise on glucose&#xD;
      metabolism and vascular function during pregnancy in n=15 obese women in order to inform a&#xD;
      large, multisite clinical trial examining the acute and chronic effects of aerobic and&#xD;
      resistance exercise on glucose metabolism and vascular function in normal weight, overweight&#xD;
      and obese women during pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maternal obesity prevalence is at a historic high with over 1 in 3 women entering pregnancy&#xD;
      obese and 1 in 10 extremely obese. Obesity before and during pregnancy is associated with a&#xD;
      higher risk for a number of obstetric and metabolic complications in women and their&#xD;
      offspring. Of particular importance, obese women have a higher risk of developing gestational&#xD;
      diabetes and preeclampsia. In addition, obese women have larger offspring who have a higher&#xD;
      risk for the development of obesity and diabetes; both largely attributed to higher maternal&#xD;
      glycemia and glucose intolerance during pregnancy. Thus, identifying rehabilitative&#xD;
      interventions that improve maternal and offspring metabolic and cardiovascular health in&#xD;
      obese pregnancy are critical and have immediate and generational impact.&#xD;
&#xD;
      Resistance and aerobic exercise training is a clinical staple for improving musculoskeletal,&#xD;
      metabolic and cardiovascular health in non-gravid adolescents and adults with obesity.&#xD;
      Observational studies suggest that exercise in pregnancy is safe and higher levels of&#xD;
      physical activity before and during pregnancy in normal weight (i.e. lean) women reduces the&#xD;
      risk of gestational diabetes and gestational hypertensive disorders; however, little is known&#xD;
      regarding the effects of exercise training during obese pregnancy and several important&#xD;
      questions still exist. These include: 1) &quot;What are the acute and chronic effects of maternal&#xD;
      exercise on glucose metabolism and vascular function?&quot;, 2) &quot;Are there different effects of&#xD;
      aerobic and resistance type exercise on glucose metabolism and vascular function?&quot; and 3)&#xD;
      &quot;What are the physiologic and molecular transducers of maternal aerobic and resistance&#xD;
      exercise for changes in maternal glucose metabolism and vascular function during pregnancy?&quot;&#xD;
      This pilot project aims to collect preliminary data on these questions.&#xD;
&#xD;
      This proposal would be the first study to collect preliminary data on the independent effects&#xD;
      of acute aerobic and resistance rehabilitative exercise in pregnancy, and further, in obese&#xD;
      women; a population with a high morbidity during gestation. In addition, this proposal would&#xD;
      inform a large, multisite clinical trial examining the acute and chronic effects of aerobic&#xD;
      and resistance exercise on glucose metabolism and vascular function in normal weight,&#xD;
      overweight and obese women during pregnancy. Moreover, this proposal would provide initial&#xD;
      evidence of molecular transducers of acute physical activity/rehabilitative exercise&#xD;
      necessary for a large, comprehensive clinical trial examining the molecular transducers of&#xD;
      rehabilitative exercise in normal weight, overweight and obese women during different stages&#xD;
      of pregnancy.&#xD;
&#xD;
      Specific Aim #1: To characterize the acute effects of aerobic and resistance exercise on&#xD;
      glucose metabolism (tolerance, insulin sensitivity and β-cell function) in obese women during&#xD;
      mid-pregnancy.&#xD;
&#xD;
      Specific Aim #2: To characterize the acute effects of aerobic and resistance exercise on&#xD;
      vascular function in obese women during mid-pregnancy.&#xD;
&#xD;
      Specific Aim #3: To explore the molecular transducers of physiologic responses in glucose&#xD;
      metabolism and vascular function following acute aerobic and resistance exercise in obese&#xD;
      women during mid-pregnancy.&#xD;
&#xD;
      The hypothesis is that acute aerobic and resistance rehabilitative exercise will improve&#xD;
      post-exercise glucose metabolism and vascular function in obese women during mid-pregnancy.&#xD;
      In a subsequent multi-site clinical trial, this study will examine differences in physiologic&#xD;
      effects and molecular transducers of aerobic and resistance exercise on glucose metabolism&#xD;
      and vascular function during different stages of pregnancy in overweight and obese women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Single group crossover design of acute effects of resistance exercise, aerobic exercise or rest (control) on maternal vascular function and glucose metabolism</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oral Glucose Insulin Sensitivity (OGIS) Index</measure>
    <time_frame>2 hours post-intervention, up to approximately 3 hours</time_frame>
    <description>Oral Glucose Insulin Sensitivity (OGIS) during a 2-hour oral glucose tolerance test. OGIS (an acronym for Oral Glucose Insulin Sensitivity) is a method for the assessment of insulin sensitivity from the oral glucose tolerance test. OGIS provides an index which is analogous to the index of insulin sensitivity obtained from the glucose clamp. Mari, et al. OGIS uses modeling of glucose values at 0, 90, 120 min and insulin values at 0 and 90 min (2-h OGTT) to calculate the index. A model-based method for assessing insulin sensitivity from the oral glucose tolerance test. Diabetes Care 2001 Mar;24(3):539-48. The formula for OGIS is the following: (glucose clearance rate + square root(glucose clearance rate*glucose clearance rate + 4*pp5*pp6(glucose at 90 min-gcl)*330))/2. A calculation spreadsheet for OGIS is found at: http://webmet.pd.cnr.it/ogis/index.php</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Change in Endothelial Function</measure>
    <time_frame>baseline and immediately post-intervention, approximately 40 minutes</time_frame>
    <description>Augmentation index: reactive hyperemic response post-blood pressure cuff inflation. Reactive hyperemia is the transient increase in organ blood flow that occurs following a brief period of ischemia (e.g., arterial occlusion).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Pregnancy Complications</condition>
  <condition>Obesity</condition>
  <condition>Pre-Eclampsia</condition>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>Acute Resistance Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One acute exercise session of 40 minutes of resistance exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute Aerobic Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One acute session of 40 minutes of aerobic exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute Resting Session</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>One session of 40 minutes of quiet rest</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resistance exercise</intervention_name>
    <description>One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise</description>
    <arm_group_label>Acute Resistance Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic Exercise</intervention_name>
    <description>One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)</description>
    <arm_group_label>Acute Aerobic Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Rest</intervention_name>
    <description>40 minutes of quiet rest in semi-recumbent position</description>
    <arm_group_label>Acute Resting Session</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. First trimester BMI ≥ 30.0 and &lt;45.0 kg/m2 (calculated from clinical weight and&#xD;
             height)&#xD;
&#xD;
          2. Singleton gestation, between 23 weeks and 0/7 days and 28 weeks and 0/7 days&#xD;
&#xD;
          3. Normal fetal anatomy (no major structural abnormalities identified on standard of care&#xD;
             survey before enrollment)&#xD;
&#xD;
          4. Established prenatal care at Women's Health Clinic before 18 weeks of gestation, plans&#xD;
             to deliver at Barnes-Jewish Hospital&#xD;
&#xD;
          5. Permission from Obstetrics physician provider to participate in study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Gestational or pre-gestational diabetes diagnosis&#xD;
&#xD;
          2. Inability to provide voluntary consent&#xD;
&#xD;
          3. Currently using illegal drugs (e.g., cocaine, methamphetamine, opiates) (safety risk&#xD;
             and potential confounding)&#xD;
&#xD;
          4. Current smoker who does not agree to stop (confounding)&#xD;
&#xD;
          5. Participation in routine (&gt;1x/week) exercise program (may improve glucose&#xD;
             metabolism/vascular function)&#xD;
&#xD;
          6. History of heart disease, orthopedic, metabolic or neurological condition that would&#xD;
             contraindicate exercise (safety risk)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Cade, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <results_first_submitted>March 22, 2021</results_first_submitted>
  <results_first_submitted_qc>June 28, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 16, 2021</results_first_posted>
  <last_update_submitted>June 28, 2021</last_update_submitted>
  <last_update_submitted_qc>June 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exercise</keyword>
  <keyword>glucose</keyword>
  <keyword>vascular</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Pregnancy Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT03750695/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The 3 interventions were: 1) 1-hour of rest, 2) 1-hour of resistance exercise, and 3) 1-hour of aerobic exercise. Each of these interventions were separated by 1-week. N=8 participants were randomized into performing these interventions in the order of rest-aerobic-resistance and n=8 participants in the order of rest-resistance-aerobic.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Rest, Then Aerobic Exercise, and Then Resistance Exercise Order</title>
          <description>Rest: 40 minutes of quiet rest in semi-recumbent position&#xD;
Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)&#xD;
Resistance exercise: One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise&#xD;
Participant performed interventions in order of rest, then aerobic exercise, then resistance exercise.</description>
        </group>
        <group group_id="P2">
          <title>Rest-Resistance-Aerobic Order</title>
          <description>Rest: 40 minutes of quiet rest in semi-recumbent position Resistance exercise: One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise&#xD;
Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)&#xD;
Participant performed interventions in order of rest, then resistance exercise, then aerobic exercise.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants who completed the study. All participants were randomized to receive all interventions.</population>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Resistance exercise: One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise&#xD;
Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)&#xD;
Rest: 40 minutes of quiet rest in semi-recumbent position</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
          </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="32" spread="6.3"/>
                  </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="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </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="8"/>
                  </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>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Oral Glucose Insulin Sensitivity (OGIS) Index</title>
        <description>Oral Glucose Insulin Sensitivity (OGIS) during a 2-hour oral glucose tolerance test. OGIS (an acronym for Oral Glucose Insulin Sensitivity) is a method for the assessment of insulin sensitivity from the oral glucose tolerance test. OGIS provides an index which is analogous to the index of insulin sensitivity obtained from the glucose clamp. Mari, et al. OGIS uses modeling of glucose values at 0, 90, 120 min and insulin values at 0 and 90 min (2-h OGTT) to calculate the index. A model-based method for assessing insulin sensitivity from the oral glucose tolerance test. Diabetes Care 2001 Mar;24(3):539-48. The formula for OGIS is the following: (glucose clearance rate + square root(glucose clearance rate*glucose clearance rate + 4*pp5*pp6(glucose at 90 min-gcl)*330))/2. A calculation spreadsheet for OGIS is found at: http://webmet.pd.cnr.it/ogis/index.php</description>
        <time_frame>2 hours post-intervention, up to approximately 3 hours</time_frame>
        <population>Participants completed all interventions but in different order</population>
        <group_list>
          <group group_id="O1">
            <title>Acute Aerobic Exercise</title>
            <description>Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)</description>
          </group>
          <group group_id="O2">
            <title>Acute Resistance Exercise</title>
            <description>Resistance exercise: One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise</description>
          </group>
          <group group_id="O3">
            <title>Acute Rest</title>
            <description>1-hour of sitting rest</description>
          </group>
        </group_list>
        <measure>
          <title>Oral Glucose Insulin Sensitivity (OGIS) Index</title>
          <description>Oral Glucose Insulin Sensitivity (OGIS) during a 2-hour oral glucose tolerance test. OGIS (an acronym for Oral Glucose Insulin Sensitivity) is a method for the assessment of insulin sensitivity from the oral glucose tolerance test. OGIS provides an index which is analogous to the index of insulin sensitivity obtained from the glucose clamp. Mari, et al. OGIS uses modeling of glucose values at 0, 90, 120 min and insulin values at 0 and 90 min (2-h OGTT) to calculate the index. A model-based method for assessing insulin sensitivity from the oral glucose tolerance test. Diabetes Care 2001 Mar;24(3):539-48. The formula for OGIS is the following: (glucose clearance rate + square root(glucose clearance rate*glucose clearance rate + 4*pp5*pp6(glucose at 90 min-gcl)*330))/2. A calculation spreadsheet for OGIS is found at: http://webmet.pd.cnr.it/ogis/index.php</description>
          <population>Participants completed all interventions but in different order</population>
          <units>uU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="405.0" spread="56.9"/>
                    <measurement group_id="O2" value="426.0" spread="53.9"/>
                    <measurement group_id="O3" value="418.9" spread="67.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in Endothelial Function</title>
        <description>Augmentation index: reactive hyperemic response post-blood pressure cuff inflation. Reactive hyperemia is the transient increase in organ blood flow that occurs following a brief period of ischemia (e.g., arterial occlusion).</description>
        <time_frame>baseline and immediately post-intervention, approximately 40 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Acute Resistance Exercise</title>
            <description>One acute exercise session of 40 minutes of resistance exercise&#xD;
Resistance exercise: One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise</description>
          </group>
          <group group_id="O2">
            <title>Acute Aerobic Exercise</title>
            <description>One acute session of 40 minutes of aerobic exercise&#xD;
Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)</description>
          </group>
          <group group_id="O3">
            <title>Acute Rest</title>
            <description>One session of 40 minutes of quiet rest&#xD;
Rest: 40 minutes of quiet rest in semi-recumbent position</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in Endothelial Function</title>
          <description>Augmentation index: reactive hyperemic response post-blood pressure cuff inflation. Reactive hyperemia is the transient increase in organ blood flow that occurs following a brief period of ischemia (e.g., arterial occlusion).</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" spread="11.0"/>
                    <measurement group_id="O2" value="20.3" spread="8.0"/>
                    <measurement group_id="O3" value="16.1" spread="7.7"/>
                  </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>O3</group_id>
            </group_id_list>
            <groups_desc>Repeated measures linear regression</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Approximately 3 hours after each intervention.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Acute Resistance Exercise</title>
          <description>One acute exercise session of 40 minutes of resistance exercise&#xD;
Resistance exercise: One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise</description>
        </group>
        <group group_id="E2">
          <title>Acute Aerobic Exercise</title>
          <description>One acute session of 40 minutes of aerobic exercise&#xD;
Aerobic Exercise: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)</description>
        </group>
        <group group_id="E3">
          <title>Acute Resting Session</title>
          <description>One session of 40 minutes of quiet rest&#xD;
Rest: 40 minutes of quiet rest in semi-recumbent position</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="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
              </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="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
              </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>Dr. William Todd Cade</name_or_title>
      <organization>Duke University</organization>
      <phone>919-660-9825</phone>
      <email>todd.cade@duke.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/NCT03750695
org study id: Pro00105627
nct id: NCT03750695
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obesity before and during pregnancy is associated with a higher risk for a number of
      obstetric and metabolic complications in women and their offspring. Of particular importance,
      obese women have a higher risk of developing gestational diabetes and preeclampsia. In
      addition, obese women have larger offspring who have a higher risk for the development of
      obesity and diabetes; both largely attributed to higher maternal glycemia and glucose
      intolerance during pregnancy. Thus, identifying rehabilitative interventions that improve
      maternal and offspring metabolic and cardiovascular health in obese pregnancy are critical
      and have immediate and generational impact. Resistance and aerobic exercise training is a
      clinical staple for improving musculoskeletal, metabolic and cardiovascular health in
      non-gravid adolescents and adults with obesity however little is known regarding the effects
      of exercise during obese pregnancy. This study proposes to collect preliminary data on the
      independent effects of acute aerobic and resistance rehabilitative exercise on glucose
      metabolism and vascular function during pregnancy in n=15 obese women in order to inform a
      large, multisite clinical trial examining the acute and chronic effects of aerobic and
      resistance exercise on glucose metabolism and vascular function in normal weight, overweight
      and obese women during pregnancy.
Maternal obesity prevalence is at a historic high with over 1 in 3 women entering pregnancy
      obese and 1 in 10 extremely obese. Obesity before and during pregnancy is associated with a
      higher risk for a number of obstetric and metabolic complications in women and their
      offspring. Of particular importance, obese women have a higher risk of developing gestational
      diabetes and preeclampsia. In addition, obese women have larger offspring who have a higher
      risk for the development of obesity and diabetes; both largely attributed to higher maternal
      glycemia and glucose intolerance during pregnancy. Thus, identifying rehabilitative
      interventions that improve maternal and offspring metabolic and cardiovascular health in
      obese pregnancy are critical and have immediate and generational impact.

      Resistance and aerobic exercise training is a clinical staple for improving musculoskeletal,
      metabolic and cardiovascular health in non-gravid adolescents and adults with obesity.
      Observational studies suggest that exercise in pregnancy is safe and higher levels of
      physical activity before and during pregnancy in normal weight (i.e. lean) women reduces the
      risk of gestational diabetes and gestational hypertensive disorders; however, little is known
      regarding the effects of exercise training during obese pregnancy and several important
      questions still exist. These include: 1) "What are the acute and chronic effects of maternal
      exercise on glucose metabolism and vascular function?", 2) "Are there different effects of
      aerobic and resistance type exercise on glucose metabolism and vascular function?" and 3)
      "What are the physiologic and molecular transducers of maternal aerobic and resistance
      exercise for changes in maternal glucose metabolism and vascular function during pregnancy?"
      This pilot project aims to collect preliminary data on these questions.

      This proposal would be the first study to collect preliminary data on the independent effects
      of acute aerobic and resistance rehabilitative exercise in pregnancy, and further, in obese
      women; a population with a high morbidity during gestation. In addition, this proposal would
      inform a large, multisite clinical trial examining the acute and chronic effects of aerobic
      and resistance exercise on glucose metabolism and vascular function in normal weight,
      overweight and obese women during pregnancy. Moreover, this proposal would provide initial
      evidence of molecular transducers of acute physical activity/rehabilitative exercise
      necessary for a large, comprehensive clinical trial examining the molecular transducers of
      rehabilitative exercise in normal weight, overweight and obese women during different stages
      of pregnancy.

      Specific Aim #1: To characterize the acute effects of aerobic and resistance exercise on
      glucose metabolism (tolerance, insulin sensitivity and β-cell function) in obese women during
      mid-pregnancy.

      Specific Aim #2: To characterize the acute effects of aerobic and resistance exercise on
      vascular function in obese women during mid-pregnancy.

      Specific Aim #3: To explore the molecular transducers of physiologic responses in glucose
      metabolism and vascular function following acute aerobic and resistance exercise in obese
      women during mid-pregnancy.

      The hypothesis is that acute aerobic and resistance rehabilitative exercise will improve
      post-exercise glucose metabolism and vascular function in obese women during mid-pregnancy.
      In a subsequent multi-site clinical trial, this study will examine differences in physiologic
      effects and molecular transducers of aerobic and resistance exercise on glucose metabolism
      and vascular function during different stages of pregnancy in overweight and obese women.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Single group crossover design of acute effects of resistance exercise, aerobic exercise or rest (control) on maternal vascular function and glucose metabolism
primary purpose: Treatment
masking: None (Open Label)
measure: Oral Glucose Insulin Sensitivity (OGIS) Index
time frame: 2 hours post-intervention, up to approximately 3 hours
description: Oral Glucose Insulin Sensitivity (OGIS) during a 2-hour oral glucose tolerance test. OGIS (an acronym for Oral Glucose Insulin Sensitivity) is a method for the assessment of insulin sensitivity from the oral glucose tolerance test. OGIS provides an index which is analogous to the index of insulin sensitivity obtained from the glucose clamp. Mari, et al. OGIS uses modeling of glucose values at 0, 90, 120 min and insulin values at 0 and 90 min (2-h OGTT) to calculate the index. A model-based method for assessing insulin sensitivity from the oral glucose tolerance test. Diabetes Care 2001 Mar;24(3):539-48. The formula for OGIS is the following: (glucose clearance rate + square root(glucose clearance rate*glucose clearance rate + 4*pp5*pp6(glucose at 90 min-gcl)*330))/2. A calculation spreadsheet for OGIS is found at: http://webmet.pd.cnr.it/ogis/index.php
measure: Percent Change in Endothelial Function
time frame: baseline and immediately post-intervention, approximately 40 minutes
description: Augmentation index: reactive hyperemic response post-blood pressure cuff inflation. Reactive hyperemia is the transient increase in organ blood flow that occurs following a brief period of ischemia (e.g., arterial occlusion).
arm group label: Acute Resistance Exercise
arm group type: Experimental
description: One acute exercise session of 40 minutes of resistance exercise
arm group label: Acute Aerobic Exercise
arm group type: Experimental
description: One acute session of 40 minutes of aerobic exercise
arm group label: Acute Resting Session
arm group type: Placebo Comparator
description: One session of 40 minutes of quiet rest
intervention type: Behavioral
intervention name: Resistance exercise
description: One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise
arm group label: Acute Resistance Exercise
intervention type: Behavioral
intervention name: Aerobic Exercise
description: One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)
arm group label: Acute Aerobic Exercise
intervention type: Behavioral
intervention name: Rest
description: 40 minutes of quiet rest in semi-recumbent position
arm group label: Acute Resting Session
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: William Cade, PhD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Eclampsia
mesh term: Pre-Eclampsia
mesh term: Pregnancy Complications
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 