<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/NCT03227575</url>
  </required_header>
  <id_info>
    <org_study_id>0001</org_study_id>
    <nct_id>NCT03227575</nct_id>
  </id_info>
  <brief_title>Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control</brief_title>
  <official_title>Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Plymouth State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Plymouth State 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>
      Physical activity is shown to positively reduce the risk of developing both cardiovascular&#xD;
      disease and type 2 diabetes. Current guidelines recommend 30-60 minutes of moderate intensity&#xD;
      cardiorespiratory exercise five days per week. However, studies report that &lt;40% of young&#xD;
      adults 18-24 years achieve the recommended weekly physical activity guidelines, and close to&#xD;
      40% of young adults are overweight or obese. Traditional aerobic exercise and high intensity&#xD;
      exercise have been shown to improve glycemic control in young and middle-aged sedentary&#xD;
      adults, however, long term implementation of such exercise regimens are difficult. Recent&#xD;
      evidence suggests that short bouts (15 minutes) of moderate intensity walking following a&#xD;
      meal, significantly improves glycemic control in older adults with impaired glucose control.&#xD;
      Due to the low burden of walking on participants, moderate intensity post-meal walking might&#xD;
      be a better alternative exercise intervention to improve overall health in a sedentary&#xD;
      population. Therefore, the purpose of this pilot proposal is to determine if 15 minutes of&#xD;
      post-meal walking is an effective intervention to improve glycemic control in sedentary young&#xD;
      adults at risk for developing MetS. Additionally, the study will investigate whether&#xD;
      ambulatory blood pressure profiles in obese young adults are disrupted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sedentary young adults (18-39 years) will be recruited from the community and surrounding&#xD;
      areas of Plymouth, NH. In order to be included in the study sample, participants must meet&#xD;
      the following criteria: a BMI &gt; 26.9, body fat % &gt;19.9% for men, body fat greater than 31.9&#xD;
      for women, and who do not participate in regular physical activity. Participants will be free&#xD;
      of any known signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease,&#xD;
      and cancer.&#xD;
&#xD;
      Questionnaires The investigators will utilize two questionnaires for the study. Investigators&#xD;
      will use a Health History Questionnaire to assess baseline health information. Investigators&#xD;
      will also use the International Physical Activity Questionnaire to assess current physical&#xD;
      activity status.&#xD;
&#xD;
      Waist Circumference, Height, Body Composition, and Weight Investigators will measure waist&#xD;
      circumference using a Gulick measuring tape. Investigators will collect height using&#xD;
      Stadiometer scale. Weight and body composition will be collected using a Tanita Scale, which&#xD;
      assesses weight and body composition&#xD;
&#xD;
      Blood Pressure Blood pressure will be measured utilizing manometry (blood pressure cuff),&#xD;
      which is traditionally used by clinicians to measure blood pressure.&#xD;
&#xD;
      Garmin VivoFit Activity Monitor A Garmin VivoFit activity monitor will be used to collect&#xD;
      daily exercise, track steps per day, and heart rate. The monitor is worn on the wrist and&#xD;
      allows for the accurate measurement of daily physical activity, steps per day, and daily&#xD;
      heart rate. These variables and other measurement variables from daily activity, heart rate,&#xD;
      and daily steps will be tracked with the watch.&#xD;
&#xD;
      IV Catheter Placement An intravenous (IV) catheter will be placed into a superficial vein&#xD;
      either at the elbow (normally where blood is drawn) or vein near the wrist (secondary option&#xD;
      for venous blood sampling). Catheter placement will be performed by Dr. Michael Brian, who&#xD;
      has been previously trained in phlebotomy and proper IV catheter insertion at the University&#xD;
      of Delaware. The IV catheter is vital for completing successive blood draws during the&#xD;
      testing visit. Professor Sandra Gamble, of the Nursing Department, will assist during data&#xD;
      collections to ensure safe blood collections.&#xD;
&#xD;
      75g Glucose Drink A standardized 75g glucose drink will be utilized to as part of the oral&#xD;
      glucose tolerance tests, which is a test to assess the body's response to glucose.&#xD;
&#xD;
      Blood Sample Processing A OneTouch portable blood glucose monitor will be used to assess&#xD;
      blood glucose from whole blood samples during the study visit. The remaining whole blood will&#xD;
      be centrifuged and the extracted serum will be stored for future insulin analysis. All serum&#xD;
      samples will be stored in a -80 freezer until analysis.&#xD;
&#xD;
      24-hour Blood Pressure Monitoring The investigators will utilize a 24-hour blood pressure&#xD;
      monitor (Oscar 2-SunTech Blood Pressure Monitor, Morrisville, NC, USA) to measure blood&#xD;
      pressure over a 24-hour period. The cuff will be fitted to the participant's arm and will&#xD;
      take blood pressure every 20 minutes during the daytime and every 30 minutes during the night&#xD;
      time. Throughout the 24-hour period, participants will be asked to maintain their normal&#xD;
      daily routines.&#xD;
&#xD;
      Questionnaires (Appendix B) We will utilize two questionnaires for the study. We will use a&#xD;
      Health History Questionnaire to assess baseline health information. We will also use the&#xD;
      International Physical Activity Questionnaire to assess current physical activity status.&#xD;
&#xD;
      Waist Circumference, Height, Body Composition, and Weight We will measure waist circumference&#xD;
      using a Gulick measuring tape. We will collect height using Stadiometer scale. Weight and&#xD;
      body composition will be collected using a Tanita Scale, which assesses weight and body&#xD;
      composition.&#xD;
&#xD;
      24-hour Blood Pressure Monitoring We will utilize a 24-hour blood pressure monitor (Oscar&#xD;
      2-SunTech Blood Pressure Monitor, Morrisville, NC, USA) to measure blood pressure over a&#xD;
      24-hour period. The cuff will be fitted to the participant's arm and will take blood pressure&#xD;
      every 20 minutes during the daytime and every 30 minutes during the night time. Throughout&#xD;
      the 24-hour period, participants will be asked to maintain their normal daily routines.&#xD;
&#xD;
      Garmin VivoFit Activity Monitor A Garmin VivoFit activity monitor will be used to collect&#xD;
      daily exercise, track steps per day, and heart rate. The monitor is worn on the wrist and&#xD;
      allows for the accurate measurement of daily physical activity, steps per day, and daily&#xD;
      heart rate. These variables and other measurement variables from daily activity, heart rate,&#xD;
      and daily steps will be tracked with the watch.&#xD;
&#xD;
      IV Catheter Placement An intravenous (IV) catheter will be placed into a superficial vein&#xD;
      either at the elbow (normally where blood is drawn) or vein near the wrist (secondary option&#xD;
      for venous blood sampling). Catheter placement will be performed by Dr. Michael Brian, who&#xD;
      has been previously trained in phlebotomy and proper IV catheter insertion at the University&#xD;
      of Delaware. The IV catheter is vital for completing successive blood draws during the&#xD;
      testing visit.&#xD;
&#xD;
      75g Glucose Drink A standardized 75g glucose drink will be utilized to as part of the oral&#xD;
      glucose tolerance tests, which is a test to assess the body's response to glucose.&#xD;
&#xD;
      Blood Sample Processing Whole blood will be spun down to separate serum and red blood cells.&#xD;
      The serum will be extracted and stored for future insulin analysis. All serum samples will be&#xD;
      stored in a -80 freezer until analysis.&#xD;
&#xD;
      Insulin Analysis In collaboration with Dr. Heather Doherty, insulin analysis will be&#xD;
      performed on stored serum blood samples using a Human Insulin ELISA kit. Dr. Doherty has&#xD;
      offered to assist and guide Dr. Brian in the proper analysis insulin levels measured from our&#xD;
      study population. The analysis will be completed following the completion of the study.&#xD;
&#xD;
      24-hour Continuous Glucose Monitor (CGM) A subcutaneous (just below the skin) Dexcom G5&#xD;
      Sensor (Dexcom; San Diego, California) will be placed on the abdomen by Dr. Michael Brian.&#xD;
      The sensor measures glucose levels in the body every 5 minutes over a 24-hour period for 7&#xD;
      days. Participants will be trained how use the equipment, which requires a participant to&#xD;
      calibrate the sensor two times daily by measuring their blood glucose through a finger prick.&#xD;
&#xD;
      Protocol All participants will complete an informed consent, and then screened prior to being&#xD;
      enrolled into the study. As part of the initial screening visit, participants will complete a&#xD;
      health history questionnaire, International Physical Activity Questionnaire (to assess&#xD;
      current sedentary status), waist circumference measurement, height &amp; weight measures, body&#xD;
      composition, and resting blood pressure. Participants will then be randomized into two study&#xD;
      groups (Post-Meal Walking Group, Traditional Exercise Group).&#xD;
&#xD;
      Continuous Glucose Monitoring Visit&#xD;
&#xD;
      Prior to the &quot;Baseline Study Visit,&quot; participants will come to the Exercise and Sports&#xD;
      Physiology Research Laboratory (Draper &amp; Maynard Building, room 417) for CGM training and&#xD;
      subcutaneous sensor insertion. Participants will receive training on proper care of the CGM&#xD;
      unit, calibration techniques, and proper lancet disposal in a Sharps container. Following CGM&#xD;
      sensor insertion and training, participants will be allowed to leave for 1.5 hours while the&#xD;
      sensor warm-ups and then return to the laboratory for sensor calibration. After sensor&#xD;
      calibration, participants will wear the CGM unit for the next 6 days. The total visit will&#xD;
      take approximately 2.5 hours (including the warm-up period).&#xD;
&#xD;
      Baseline Study Visit&#xD;
&#xD;
      Six days after the CGM insertion, participants will arrive 8 hours fasted to the Exercise and&#xD;
      Sports Physiology Research Laboratory (D&amp;M 417) on the morning of the study visit.&#xD;
      Participants will be asked to complete a three-day diet record. Baseline measurements of&#xD;
      height, weight, waist circumference, blood pressure, heart rate, and body composition will be&#xD;
      made. Following the baseline measurements, Michael Brian (PhD) will insert a catheter into&#xD;
      the arm of the participant, leaving a small flexible tubing in the arm to collect blood&#xD;
      samples throughout the protocol. A baseline blood collection will be performed to assess&#xD;
      fasting insulin levels in the body.&#xD;
&#xD;
      Participants will then complete an oral glucose tolerance test. Participants will consume a&#xD;
      75g glucose drink to measure the participant's glycemic response. The glucose drink simulates&#xD;
      an individual consuming a high sugar load, like a soda. Blood samples will be collected at&#xD;
      30, 60, and 120-minute time points following glucose consumption. Following the completion of&#xD;
      the oral glucose tolerance test, the catheter and CGM will be removed and vitals checked&#xD;
      (blood pressure &amp; heart rate). Participants will then be provided with a 24-hour blood&#xD;
      pressure monitor to wear. The participants will return the blood pressure monitor the&#xD;
      following day.&#xD;
&#xD;
      4-Week Exercise Intervention&#xD;
&#xD;
      Following the &quot;Initial Study Visit,&quot; participants will be provided with detailed instructions&#xD;
      for their intervention. Participants will be randomly divided into two groups: Post-Meal&#xD;
      Walking Group and Traditional Exercise Control Group.&#xD;
&#xD;
      Throughout the 4-weeks, participants will be asked to continue their regular diet and daily&#xD;
      levels of physical activity. They will be instructed that changing their diet or physical&#xD;
      activity levels outside of the study can significantly impact the study results.&#xD;
&#xD;
      Post-Meal Walking Group&#xD;
&#xD;
      Following a 30-minute digestion period, the Post-Meal Walking Group will be instructed to&#xD;
      walk following breakfast, lunch, and dinner at least 4 times per week (180 minutes of&#xD;
      moderate intensity exercise/week). Participants will walk at a brisk pace for 15 minutes, as&#xD;
      demonstrated in a previous study (5). A Garmin VivoFit activity monitor will measure their&#xD;
      physical activity across the four-week intervention. The Garmin VivoFit activity monitor must&#xD;
      be returned during the &quot;Follow-up Study Visit&quot;.&#xD;
&#xD;
      Traditional Exercise Group&#xD;
&#xD;
      The Traditional Exercise Group will perform aerobic and light resistance training exercise&#xD;
      over the 4-week intervention. A group of trained Exercise and Sports Physiology students will&#xD;
      conduct the aerobic exercise and light resistance training program three times per week (180&#xD;
      minutes of moderate to high intensity exercise/week). Garmin VivoFit activity monitors will&#xD;
      measure their physical activity across the four-week intervention. The Garmin VivoFit&#xD;
      activity monitor must be returned during the &quot;Follow-up Study Visit&quot;.&#xD;
&#xD;
      A general exercise prescription will be used to standardized all Traditional Exercise&#xD;
      sessions.&#xD;
&#xD;
      Follow-up Study Visit&#xD;
&#xD;
      Participants will complete all of the measurements performed during the &quot;Initial Study Visit&quot;&#xD;
      and all activity monitors will be collected.&#xD;
&#xD;
      Case Control Study&#xD;
&#xD;
      A case control study will be used to measure ambulatory 24-hour blood pressure monitoring in&#xD;
      healthy sedentary controls. This will help in our attempt to determine whether 24-hour blood&#xD;
      pressure control is disrupted in sedentary obese individuals.&#xD;
&#xD;
      After an initial screening visit, participants will wear an ambulatory blood pressure monitor&#xD;
      for 24 hours, and return it the next day. The participants will be instructed to maintain&#xD;
      their current diet and levels of physical activity for four weeks. Any change in diet and&#xD;
      physical activity level might affect the study results. A Garmin VivoFit activity monitor&#xD;
      will be provided to measure their physical activity over four weeks. At the end of the 4-week&#xD;
      period, participants will have their 24-hour blood pressure measured again. The Garmin&#xD;
      VivoFit activity monitor and 24-hour blood pressure cuff must be returned the day after the&#xD;
      24-hour blood pressure monitoring period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine whether ambulatory blood glucose control responses are improved following 28 days of exercise training (Post Training).</measure>
    <time_frame>An average of 32 days will separate these two measurements.</time_frame>
    <description>Examine blood glucose (mg/dL) responses during two oral glucose tolerance test (70g glucose drink). The first test will be measured at baseline (Base) and the second test will be measured following 28 days of exercise training. These two tests (Base vs Post Training) will be separated by an average of 32 days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine whether serum insulin (IU/mL) responses are improved following 28 days of exercise training (Post Training).</measure>
    <time_frame>An average of 32 days will separate these two measurements.</time_frame>
    <description>Examine serum insulin (IU/mL) responses during two oral glucose tolerance tests (70g glucose drink). The first test will be measured at baseline (Base) and the second test will be measured following 28 days of exercise training. These two tests (Base vs Post Training) will be separated by an average of 32 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine whether ambulatory blood pressure profiles are different following an average of 28 day exercise intervention compared to sedentary healthy controls.</measure>
    <time_frame>An average of 28 days will separate these two measurements.</time_frame>
    <description>We will exam ambulatory 24-hour blood pressure profiles in healthy sedentary young adults at baseline, and then re-measure ambulatory 24-hour blood pressure profiles during a follow-up visit. These will be compared to our obese young adults.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">33</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Post-Meal Walking Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following a 30-minute digestion period, the Post-Meal Walking Group will be instructed to walk following breakfast, lunch, and dinner at least 4 times per week (180 minutes of moderate intensity exercise/week). Participants will walk at a brisk pace for 15 minutes, as demonstrated in a previous study. A Garmin VivoFit activity monitor will measure their physical activity across the four-week intervention. The Garmin VivoFit activity monitor must be returned during the &quot;Follow-up Study Visit&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Traditional Exercise Group will perform aerobic and light resistance training exercise over the 4-week intervention. A group of trained Exercise and Sports Physiology students will conduct the aerobic exercise and light resistance training program three times per week (180 minutes of moderate to high intensity exercise/week). Garmin VivoFit activity monitors will measure their physical activity across the four-week intervention. The Garmin VivoFit activity monitor must be returned during the &quot;Follow-up Study Visit&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Case Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participant will be instructed to maintain their current diet and levels of physical activity for four weeks. Participants in this group will wear an ambulatory blood pressure monitor at baseline and at follow-up. Any change in diet and physical activity level might significantly affect the study results. The Control Group will maintain their current lifestyle for four weeks. Garmin VivoFit activity monitors will measure their physical activity throughout the 4-week intervention. The Garmin VivoFit activity monitor must be returned during the &quot;Follow-up Study Visit&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>The use of exercise to improve glycemic responses in young adults who are at risk for Metabolic Syndrome.</description>
    <arm_group_label>Post-Meal Walking Group</arm_group_label>
    <arm_group_label>Traditional Exercise Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index ≥ 30&#xD;
&#xD;
          -  Currently not physically active&#xD;
&#xD;
          -  Free of any signs and symptoms of cardiovascular disease, diabetes, chronic kidney&#xD;
             disease, and cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planning to become pregnant&#xD;
&#xD;
          -  Any known signs and symptoms of cardiovascular disease, diabetes, chronic kidney&#xD;
             disease, and cancer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Michael Brian, PhD</last_name>
    <phone>603-535-3108</phone>
    <email>msbrian@plymouth.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Draper &amp; Maynard</name>
      <address>
        <city>Plymouth</city>
        <state>New Hampshire</state>
        <zip>03264</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael S Brian, PhD</last_name>
      <phone>603-535-3108</phone>
      <email>msbrian@plymouth.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Plymouth State University</name>
      <address>
        <city>Plymouth</city>
        <state>New Hampshire</state>
        <zip>03264</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Andrew Ines</last_name>
      <phone>603-535-3233</phone>
      <email>agines@plymouth.edu</email>
    </contact>
    <investigator>
      <last_name>Michael Brian, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>June 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>March 25, 2019</last_update_submitted>
  <last_update_submitted_qc>March 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2019</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03227575
org study id: 0001
nct id: NCT03227575
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Physical activity is shown to positively reduce the risk of developing both cardiovascular
      disease and type 2 diabetes. Current guidelines recommend 30-60 minutes of moderate intensity
      cardiorespiratory exercise five days per week. However, studies report that <40% of young
      adults 18-24 years achieve the recommended weekly physical activity guidelines, and close to
      40% of young adults are overweight or obese. Traditional aerobic exercise and high intensity
      exercise have been shown to improve glycemic control in young and middle-aged sedentary
      adults, however, long term implementation of such exercise regimens are difficult. Recent
      evidence suggests that short bouts (15 minutes) of moderate intensity walking following a
      meal, significantly improves glycemic control in older adults with impaired glucose control.
      Due to the low burden of walking on participants, moderate intensity post-meal walking might
      be a better alternative exercise intervention to improve overall health in a sedentary
      population. Therefore, the purpose of this pilot proposal is to determine if 15 minutes of
      post-meal walking is an effective intervention to improve glycemic control in sedentary young
      adults at risk for developing MetS. Additionally, the study will investigate whether
      ambulatory blood pressure profiles in obese young adults are disrupted.
Sedentary young adults (18-39 years) will be recruited from the community and surrounding
      areas of Plymouth, NH. In order to be included in the study sample, participants must meet
      the following criteria: a BMI > 26.9, body fat % >19.9% for men, body fat greater than 31.9
      for women, and who do not participate in regular physical activity. Participants will be free
      of any known signs and symptoms of cardiovascular disease, diabetes, chronic kidney disease,
      and cancer.

      Questionnaires The investigators will utilize two questionnaires for the study. Investigators
      will use a Health History Questionnaire to assess baseline health information. Investigators
      will also use the International Physical Activity Questionnaire to assess current physical
      activity status.

      Waist Circumference, Height, Body Composition, and Weight Investigators will measure waist
      circumference using a Gulick measuring tape. Investigators will collect height using
      Stadiometer scale. Weight and body composition will be collected using a Tanita Scale, which
      assesses weight and body composition

      Blood Pressure Blood pressure will be measured utilizing manometry (blood pressure cuff),
      which is traditionally used by clinicians to measure blood pressure.

      Garmin VivoFit Activity Monitor A Garmin VivoFit activity monitor will be used to collect
      daily exercise, track steps per day, and heart rate. The monitor is worn on the wrist and
      allows for the accurate measurement of daily physical activity, steps per day, and daily
      heart rate. These variables and other measurement variables from daily activity, heart rate,
      and daily steps will be tracked with the watch.

      IV Catheter Placement An intravenous (IV) catheter will be placed into a superficial vein
      either at the elbow (normally where blood is drawn) or vein near the wrist (secondary option
      for venous blood sampling). Catheter placement will be performed by Dr. Michael Brian, who
      has been previously trained in phlebotomy and proper IV catheter insertion at the University
      of Delaware. The IV catheter is vital for completing successive blood draws during the
      testing visit. Professor Sandra Gamble, of the Nursing Department, will assist during data
      collections to ensure safe blood collections.

      75g Glucose Drink A standardized 75g glucose drink will be utilized to as part of the oral
      glucose tolerance tests, which is a test to assess the body's response to glucose.

      Blood Sample Processing A OneTouch portable blood glucose monitor will be used to assess
      blood glucose from whole blood samples during the study visit. The remaining whole blood will
      be centrifuged and the extracted serum will be stored for future insulin analysis. All serum
      samples will be stored in a -80 freezer until analysis.

      24-hour Blood Pressure Monitoring The investigators will utilize a 24-hour blood pressure
      monitor (Oscar 2-SunTech Blood Pressure Monitor, Morrisville, NC, USA) to measure blood
      pressure over a 24-hour period. The cuff will be fitted to the participant's arm and will
      take blood pressure every 20 minutes during the daytime and every 30 minutes during the night
      time. Throughout the 24-hour period, participants will be asked to maintain their normal
      daily routines.

      Questionnaires (Appendix B) We will utilize two questionnaires for the study. We will use a
      Health History Questionnaire to assess baseline health information. We will also use the
      International Physical Activity Questionnaire to assess current physical activity status.

      Waist Circumference, Height, Body Composition, and Weight We will measure waist circumference
      using a Gulick measuring tape. We will collect height using Stadiometer scale. Weight and
      body composition will be collected using a Tanita Scale, which assesses weight and body
      composition.

      24-hour Blood Pressure Monitoring We will utilize a 24-hour blood pressure monitor (Oscar
      2-SunTech Blood Pressure Monitor, Morrisville, NC, USA) to measure blood pressure over a
      24-hour period. The cuff will be fitted to the participant's arm and will take blood pressure
      every 20 minutes during the daytime and every 30 minutes during the night time. Throughout
      the 24-hour period, participants will be asked to maintain their normal daily routines.

      Garmin VivoFit Activity Monitor A Garmin VivoFit activity monitor will be used to collect
      daily exercise, track steps per day, and heart rate. The monitor is worn on the wrist and
      allows for the accurate measurement of daily physical activity, steps per day, and daily
      heart rate. These variables and other measurement variables from daily activity, heart rate,
      and daily steps will be tracked with the watch.

      IV Catheter Placement An intravenous (IV) catheter will be placed into a superficial vein
      either at the elbow (normally where blood is drawn) or vein near the wrist (secondary option
      for venous blood sampling). Catheter placement will be performed by Dr. Michael Brian, who
      has been previously trained in phlebotomy and proper IV catheter insertion at the University
      of Delaware. The IV catheter is vital for completing successive blood draws during the
      testing visit.

      75g Glucose Drink A standardized 75g glucose drink will be utilized to as part of the oral
      glucose tolerance tests, which is a test to assess the body's response to glucose.

      Blood Sample Processing Whole blood will be spun down to separate serum and red blood cells.
      The serum will be extracted and stored for future insulin analysis. All serum samples will be
      stored in a -80 freezer until analysis.

      Insulin Analysis In collaboration with Dr. Heather Doherty, insulin analysis will be
      performed on stored serum blood samples using a Human Insulin ELISA kit. Dr. Doherty has
      offered to assist and guide Dr. Brian in the proper analysis insulin levels measured from our
      study population. The analysis will be completed following the completion of the study.

      24-hour Continuous Glucose Monitor (CGM) A subcutaneous (just below the skin) Dexcom G5
      Sensor (Dexcom; San Diego, California) will be placed on the abdomen by Dr. Michael Brian.
      The sensor measures glucose levels in the body every 5 minutes over a 24-hour period for 7
      days. Participants will be trained how use the equipment, which requires a participant to
      calibrate the sensor two times daily by measuring their blood glucose through a finger prick.

      Protocol All participants will complete an informed consent, and then screened prior to being
      enrolled into the study. As part of the initial screening visit, participants will complete a
      health history questionnaire, International Physical Activity Questionnaire (to assess
      current sedentary status), waist circumference measurement, height & weight measures, body
      composition, and resting blood pressure. Participants will then be randomized into two study
      groups (Post-Meal Walking Group, Traditional Exercise Group).

      Continuous Glucose Monitoring Visit

      Prior to the "Baseline Study Visit," participants will come to the Exercise and Sports
      Physiology Research Laboratory (Draper & Maynard Building, room 417) for CGM training and
      subcutaneous sensor insertion. Participants will receive training on proper care of the CGM
      unit, calibration techniques, and proper lancet disposal in a Sharps container. Following CGM
      sensor insertion and training, participants will be allowed to leave for 1.5 hours while the
      sensor warm-ups and then return to the laboratory for sensor calibration. After sensor
      calibration, participants will wear the CGM unit for the next 6 days. The total visit will
      take approximately 2.5 hours (including the warm-up period).

      Baseline Study Visit

      Six days after the CGM insertion, participants will arrive 8 hours fasted to the Exercise and
      Sports Physiology Research Laboratory (D&M 417) on the morning of the study visit.
      Participants will be asked to complete a three-day diet record. Baseline measurements of
      height, weight, waist circumference, blood pressure, heart rate, and body composition will be
      made. Following the baseline measurements, Michael Brian (PhD) will insert a catheter into
      the arm of the participant, leaving a small flexible tubing in the arm to collect blood
      samples throughout the protocol. A baseline blood collection will be performed to assess
      fasting insulin levels in the body.

      Participants will then complete an oral glucose tolerance test. Participants will consume a
      75g glucose drink to measure the participant's glycemic response. The glucose drink simulates
      an individual consuming a high sugar load, like a soda. Blood samples will be collected at
      30, 60, and 120-minute time points following glucose consumption. Following the completion of
      the oral glucose tolerance test, the catheter and CGM will be removed and vitals checked
      (blood pressure & heart rate). Participants will then be provided with a 24-hour blood
      pressure monitor to wear. The participants will return the blood pressure monitor the
      following day.

      4-Week Exercise Intervention

      Following the "Initial Study Visit," participants will be provided with detailed instructions
      for their intervention. Participants will be randomly divided into two groups: Post-Meal
      Walking Group and Traditional Exercise Control Group.

      Throughout the 4-weeks, participants will be asked to continue their regular diet and daily
      levels of physical activity. They will be instructed that changing their diet or physical
      activity levels outside of the study can significantly impact the study results.

      Post-Meal Walking Group

      Following a 30-minute digestion period, the Post-Meal Walking Group will be instructed to
      walk following breakfast, lunch, and dinner at least 4 times per week (180 minutes of
      moderate intensity exercise/week). Participants will walk at a brisk pace for 15 minutes, as
      demonstrated in a previous study (5). A Garmin VivoFit activity monitor will measure their
      physical activity across the four-week intervention. The Garmin VivoFit activity monitor must
      be returned during the "Follow-up Study Visit".

      Traditional Exercise Group

      The Traditional Exercise Group will perform aerobic and light resistance training exercise
      over the 4-week intervention. A group of trained Exercise and Sports Physiology students will
      conduct the aerobic exercise and light resistance training program three times per week (180
      minutes of moderate to high intensity exercise/week). Garmin VivoFit activity monitors will
      measure their physical activity across the four-week intervention. The Garmin VivoFit
      activity monitor must be returned during the "Follow-up Study Visit".

      A general exercise prescription will be used to standardized all Traditional Exercise
      sessions.

      Follow-up Study Visit

      Participants will complete all of the measurements performed during the "Initial Study Visit"
      and all activity monitors will be collected.

      Case Control Study

      A case control study will be used to measure ambulatory 24-hour blood pressure monitoring in
      healthy sedentary controls. This will help in our attempt to determine whether 24-hour blood
      pressure control is disrupted in sedentary obese individuals.

      After an initial screening visit, participants will wear an ambulatory blood pressure monitor
      for 24 hours, and return it the next day. The participants will be instructed to maintain
      their current diet and levels of physical activity for four weeks. Any change in diet and
      physical activity level might affect the study results. A Garmin VivoFit activity monitor
      will be provided to measure their physical activity over four weeks. At the end of the 4-week
      period, participants will have their 24-hour blood pressure measured again. The Garmin
      VivoFit activity monitor and 24-hour blood pressure cuff must be returned the day after the
      24-hour blood pressure monitoring period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Determine whether ambulatory blood glucose control responses are improved following 28 days of exercise training (Post Training).
time frame: An average of 32 days will separate these two measurements.
description: Examine blood glucose (mg/dL) responses during two oral glucose tolerance test (70g glucose drink). The first test will be measured at baseline (Base) and the second test will be measured following 28 days of exercise training. These two tests (Base vs Post Training) will be separated by an average of 32 days.
measure: Determine whether serum insulin (IU/mL) responses are improved following 28 days of exercise training (Post Training).
time frame: An average of 32 days will separate these two measurements.
description: Examine serum insulin (IU/mL) responses during two oral glucose tolerance tests (70g glucose drink). The first test will be measured at baseline (Base) and the second test will be measured following 28 days of exercise training. These two tests (Base vs Post Training) will be separated by an average of 32 days.
measure: Determine whether ambulatory blood pressure profiles are different following an average of 28 day exercise intervention compared to sedentary healthy controls.
time frame: An average of 28 days will separate these two measurements.
description: We will exam ambulatory 24-hour blood pressure profiles in healthy sedentary young adults at baseline, and then re-measure ambulatory 24-hour blood pressure profiles during a follow-up visit. These will be compared to our obese young adults.
arm group label: Post-Meal Walking Group
arm group type: Experimental
description: Following a 30-minute digestion period, the Post-Meal Walking Group will be instructed to walk following breakfast, lunch, and dinner at least 4 times per week (180 minutes of moderate intensity exercise/week). Participants will walk at a brisk pace for 15 minutes, as demonstrated in a previous study. A Garmin VivoFit activity monitor will measure their physical activity across the four-week intervention. The Garmin VivoFit activity monitor must be returned during the "Follow-up Study Visit".
arm group label: Traditional Exercise Group
arm group type: Experimental
description: The Traditional Exercise Group will perform aerobic and light resistance training exercise over the 4-week intervention. A group of trained Exercise and Sports Physiology students will conduct the aerobic exercise and light resistance training program three times per week (180 minutes of moderate to high intensity exercise/week). Garmin VivoFit activity monitors will measure their physical activity across the four-week intervention. The Garmin VivoFit activity monitor must be returned during the "Follow-up Study Visit".
arm group label: Case Control Group
arm group type: No Intervention
description: The participant will be instructed to maintain their current diet and levels of physical activity for four weeks. Participants in this group will wear an ambulatory blood pressure monitor at baseline and at follow-up. Any change in diet and physical activity level might significantly affect the study results. The Control Group will maintain their current lifestyle for four weeks. Garmin VivoFit activity monitors will measure their physical activity throughout the 4-week intervention. The Garmin VivoFit activity monitor must be returned during the "Follow-up Study Visit".
intervention type: Behavioral
intervention name: Exercise Intervention
description: The use of exercise to improve glycemic responses in young adults who are at risk for Metabolic Syndrome.
arm group label: Post-Meal Walking Group
arm group label: Traditional Exercise Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Brian, PhD
phone: 603-535-3108
email: msbrian@plymouth.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Metabolic Syndrome
sharing ipd: No