<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/NCT03261531</url>
  </required_header>
  <id_info>
    <org_study_id>16-001916</org_study_id>
    <nct_id>NCT03261531</nct_id>
  </id_info>
  <brief_title>Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity</brief_title>
  <official_title>Effect of T6 Dermatome Electrical Stimulation on Gastric Motor Functions, Appetite, Satiation, Satiety and Weight Loss in Individuals With Overweight and Class I Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Elira Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators are doing this research study to find out the effect of T6 dermatomal&#xD;
      electrical stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS)&#xD;
      unit) on appetite and weight loss.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be treated before and after two meals of the day with T6 dermatomal&#xD;
      electrical stimulation delivered by a Transcutaneous Electrical Nerve Stimulation (TENS)&#xD;
      unit. Participants will receive 15-minute T6 dermatome cutaneous stimulation with TENS unit&#xD;
      applied immediately before ingestion of two of main meals of the day (breakfast and evening&#xD;
      meal), and 60 minute stimulation applied immediately after ingestion of these meals.&#xD;
      Participants will apply the stimulus four times daily for a treatment period of at least 3&#xD;
      months. Participants will keep a diary of weight once weekly and a weekly appetite record.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Device failure&#xD;
  </why_stopped>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Weight</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Change in body weight will be measured in kilograms or pounds</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastric Half-emptying Time (GE T 1/2)</measure>
    <time_frame>After 1 day treatment (approximately at 4 hours)</time_frame>
    <description>The time for half of the ingested solids to leave the stomach</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gastric Half-emptying Time (GE T 1/2)</measure>
    <time_frame>At 3 months, approximately 2 hours after radiolabeled meal is ingested</time_frame>
    <description>The time for half of the ingested solids to leave the stomach</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting Gastric Volume by 99mTc-SPECT Imaging</measure>
    <time_frame>At 3 months, approx 20 minutes after 99mTC injection</time_frame>
    <description>A noninvasive SPECT method will be used to measure gastric volume. Subjects will report to the clinic after an overnight fast. The first fasting scan will be obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial Gastric Volume (Gastric Accommodation) by 99mTc-SPECT Imaging</measure>
    <time_frame>At 3 months, approximately 30 min after liquid meal</time_frame>
    <description>A noninvasive SPECT method will be used to measure gastric volume after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC will be given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gastric Emptying Percentage</measure>
    <time_frame>Day 1, 3 months</time_frame>
    <description>The time for gastric retention of ingested solids or liquid to leave the stomach, measured in percentage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satiation Volume (Level 3)</measure>
    <time_frame>Approximately 30 minutes after the liquid meal</time_frame>
    <description>Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal (&quot;volume to fullness&quot;), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satiation Maximum Tolerated Volume (Level 5)</measure>
    <time_frame>Approximately 30 minutes after the liquid meal</time_frame>
    <description>Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal (&quot;volume to fullness&quot;), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Kcal Intake at Buffet Meal as a Measure of Appetite</measure>
    <time_frame>At 3 months, approximately 30 minutes after the buffet meal</time_frame>
    <description>Assessment of kcal intake as a measure of appetite buffet meal to measure total caloric intake. 5 hours after ingesting 300 mL liquid nutrient as part of the gastric volume study, participants will be invited to eat, during a 30-minute period, a standard &quot;free feeding&quot; meal. The total amount of food consumed will be analyzed by the study dietitian.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Appetite Score</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Ratings of appetite will be measured every 30 minutes between the time of ingestion of standard liquid breakfast and the start of the ad libitum meal. The appetite rating will be measured by 4- 100 mm long Visual Analog Scales (VAS). The VAS does not have any pre-set marks between the extremes of 0 for negative rating and 100 mm for positive rating. The investigator measures the mark made by the participant in mm and records this for the value. The overall appetite score will be calculated as the average of the four individual scores (satiety + fullness+100-prospective food consumption + hunger/4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months</measure>
    <time_frame>baseline, 90 minutes postprandially</time_frame>
    <description>Total ghrelin will be measured by a radioimmunoassay technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting and Peak Postprandial Glucagon-like Peptide-1 (GLP-1) at 3 Months</measure>
    <time_frame>baseline, 90 minutes postprandially</time_frame>
    <description>Glucagon-like peptide-1 (GLP-1) will be measured by a radioimmunoassay technique.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months</measure>
    <time_frame>baseline, 90 minutes postprandially</time_frame>
    <description>Peptide Tyrosine Tyrosine (PYY) will be measured by radioimmunoassay.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Transcutaneous electrical nerve stimulation (TENS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcutaneous electrical nerve stimulation (TENS)</intervention_name>
    <description>Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
    <arm_group_label>Transcutaneous electrical nerve stimulation (TENS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Overweight and obese adults (BMI ≥25 kg/m2 and ≤34.99 kg/m2) residing within 125 miles&#xD;
             of Mayo Clinic in Rochester, Minnesota; these will be otherwise healthy individuals&#xD;
             with no unstable psychiatric disease and not currently on treatment for cardiac,&#xD;
             pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine&#xD;
             (other than hyperglycemia on diet) disorders.&#xD;
&#xD;
          -  Age: 18-65 years&#xD;
&#xD;
          -  Gender: Men or women. Women of childbearing potential will be using an effective form&#xD;
             of contraception, and have negative pregnancy tests within 48 hours of enrollment and&#xD;
             before each radiation exposure.&#xD;
&#xD;
          -  Subjects must have the ability to provide informed consent before any trial-related&#xD;
             activities.&#xD;
&#xD;
        Eligible individuals will be asked to avoid taking additional medications and supplements&#xD;
        for the duration of the study, unless reviewed and approved by the study team.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abdominal surgery other than appendectomy, Caesarian section or tubal ligation&#xD;
&#xD;
          -  Positive history of chronic gastrointestinal diseases, systemic disease that could&#xD;
             affect gastrointestinal motility, or use of medications that may alter&#xD;
             gastrointestinal motility, appetite or absorption, e.g., Orlistat&#xD;
&#xD;
          -  Positive history of diabetes mellitus or use of hypoglycemic medications&#xD;
&#xD;
          -  Positive history of spinal cord injury and/or chronic back pain&#xD;
&#xD;
          -  Significant untreated psychiatric dysfunction based upon screening with the Hospital&#xD;
             Anxiety and Depression Inventory (HAD) (12), a self-administered alcoholism screening&#xD;
             test (AUDIT-C) (13), and the Questionnaire on Eating and Weight Patterns (binge eating&#xD;
             disorders and bulimia) (14). If such a dysfunction is identified by a HAD score &gt;11 or&#xD;
             difficulties with substance or eating disorders, the participant will be excluded and&#xD;
             given a referral letter to his/her primary care doctor for further appraisal and&#xD;
             follow-up.&#xD;
&#xD;
          -  Intake of medication, whether prescribed or over the counter (except multivitamins),&#xD;
             within 7 days of the study. Exceptions are birth control pill, estrogen replacement&#xD;
             therapy, thyroxine replacement therapy, low dose analgesia or anti-inflammatory&#xD;
             medications (Acetaminophen and Ibuprofen) and any medication administered for&#xD;
             co-morbidities as long as they do not alter gastrointestinal motility including&#xD;
             gastric emptying and gastric accommodation.&#xD;
&#xD;
          -  Subjects may also be excluded from participation for other factors at the discretion&#xD;
             of the principal investigator.&#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>Michael Camilleri, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <results_first_submitted>January 14, 2020</results_first_submitted>
  <results_first_submitted_qc>January 14, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 5, 2020</results_first_posted>
  <last_update_submitted>January 14, 2020</last_update_submitted>
  <last_update_submitted_qc>January 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Michael Camilleri, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Overweight</keyword>
  <keyword>Class I Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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>April 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03261531/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
          <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
          <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
          </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="46" spread="12.2"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Body Weight</title>
        <description>Change in body weight will be measured in kilograms or pounds</description>
        <time_frame>Baseline, 3 months</time_frame>
        <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
        <group_list>
          <group group_id="O1">
            <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
            <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Body Weight</title>
          <description>Change in body weight will be measured in kilograms or pounds</description>
          <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Gastric Half-emptying Time (GE T 1/2)</title>
        <description>The time for half of the ingested solids to leave the stomach</description>
        <time_frame>After 1 day treatment (approximately at 4 hours)</time_frame>
        <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
        <group_list>
          <group group_id="O1">
            <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
            <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
          </group>
        </group_list>
        <measure>
          <title>Gastric Half-emptying Time (GE T 1/2)</title>
          <description>The time for half of the ingested solids to leave the stomach</description>
          <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Gastric Half-emptying Time (GE T 1/2)</title>
        <description>The time for half of the ingested solids to leave the stomach</description>
        <time_frame>At 3 months, approximately 2 hours after radiolabeled meal is ingested</time_frame>
        <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
        <group_list>
          <group group_id="O1">
            <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
            <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
          </group>
        </group_list>
        <measure>
          <title>Gastric Half-emptying Time (GE T 1/2)</title>
          <description>The time for half of the ingested solids to leave the stomach</description>
          <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fasting Gastric Volume by 99mTc-SPECT Imaging</title>
        <description>A noninvasive SPECT method will be used to measure gastric volume. Subjects will report to the clinic after an overnight fast. The first fasting scan will be obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.</description>
        <time_frame>At 3 months, approx 20 minutes after 99mTC injection</time_frame>
        <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
        <group_list>
          <group group_id="O1">
            <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
            <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
          </group>
        </group_list>
        <measure>
          <title>Fasting Gastric Volume by 99mTc-SPECT Imaging</title>
          <description>A noninvasive SPECT method will be used to measure gastric volume. Subjects will report to the clinic after an overnight fast. The first fasting scan will be obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.</description>
          <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postprandial Gastric Volume (Gastric Accommodation) by 99mTc-SPECT Imaging</title>
        <description>A noninvasive SPECT method will be used to measure gastric volume after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC will be given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.</description>
        <time_frame>At 3 months, approximately 30 min after liquid meal</time_frame>
        <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
        <group_list>
          <group group_id="O1">
            <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
            <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
          </group>
        </group_list>
        <measure>
          <title>Postprandial Gastric Volume (Gastric Accommodation) by 99mTc-SPECT Imaging</title>
          <description>A noninvasive SPECT method will be used to measure gastric volume after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC will be given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.</description>
          <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Gastric Emptying Percentage</title>
        <description>The time for gastric retention of ingested solids or liquid to leave the stomach, measured in percentage.</description>
        <time_frame>Day 1, 3 months</time_frame>
        <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
        <group_list>
          <group group_id="O1">
            <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
            <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Gastric Emptying Percentage</title>
          <description>The time for gastric retention of ingested solids or liquid to leave the stomach, measured in percentage.</description>
          <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satiation Volume (Level 3)</title>
        <description>Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal (&quot;volume to fullness&quot;), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.</description>
        <time_frame>Approximately 30 minutes after the liquid meal</time_frame>
        <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
        <group_list>
          <group group_id="O1">
            <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
            <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
          </group>
        </group_list>
        <measure>
          <title>Satiation Volume (Level 3)</title>
          <description>Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal (&quot;volume to fullness&quot;), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.</description>
          <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satiation Maximum Tolerated Volume (Level 5)</title>
        <description>Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal (&quot;volume to fullness&quot;), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.</description>
        <time_frame>Approximately 30 minutes after the liquid meal</time_frame>
        <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
        <group_list>
          <group group_id="O1">
            <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
            <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
          </group>
        </group_list>
        <measure>
          <title>Satiation Maximum Tolerated Volume (Level 5)</title>
          <description>Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal (&quot;volume to fullness&quot;), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.</description>
          <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Kcal Intake at Buffet Meal as a Measure of Appetite</title>
        <description>Assessment of kcal intake as a measure of appetite buffet meal to measure total caloric intake. 5 hours after ingesting 300 mL liquid nutrient as part of the gastric volume study, participants will be invited to eat, during a 30-minute period, a standard &quot;free feeding&quot; meal. The total amount of food consumed will be analyzed by the study dietitian.</description>
        <time_frame>At 3 months, approximately 30 minutes after the buffet meal</time_frame>
        <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
        <group_list>
          <group group_id="O1">
            <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
            <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Kcal Intake at Buffet Meal as a Measure of Appetite</title>
          <description>Assessment of kcal intake as a measure of appetite buffet meal to measure total caloric intake. 5 hours after ingesting 300 mL liquid nutrient as part of the gastric volume study, participants will be invited to eat, during a 30-minute period, a standard &quot;free feeding&quot; meal. The total amount of food consumed will be analyzed by the study dietitian.</description>
          <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Appetite Score</title>
        <description>Ratings of appetite will be measured every 30 minutes between the time of ingestion of standard liquid breakfast and the start of the ad libitum meal. The appetite rating will be measured by 4- 100 mm long Visual Analog Scales (VAS). The VAS does not have any pre-set marks between the extremes of 0 for negative rating and 100 mm for positive rating. The investigator measures the mark made by the participant in mm and records this for the value. The overall appetite score will be calculated as the average of the four individual scores (satiety + fullness+100-prospective food consumption + hunger/4.</description>
        <time_frame>Baseline, 3 months</time_frame>
        <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
        <group_list>
          <group group_id="O1">
            <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
            <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Appetite Score</title>
          <description>Ratings of appetite will be measured every 30 minutes between the time of ingestion of standard liquid breakfast and the start of the ad libitum meal. The appetite rating will be measured by 4- 100 mm long Visual Analog Scales (VAS). The VAS does not have any pre-set marks between the extremes of 0 for negative rating and 100 mm for positive rating. The investigator measures the mark made by the participant in mm and records this for the value. The overall appetite score will be calculated as the average of the four individual scores (satiety + fullness+100-prospective food consumption + hunger/4.</description>
          <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months</title>
        <description>Total ghrelin will be measured by a radioimmunoassay technique.</description>
        <time_frame>baseline, 90 minutes postprandially</time_frame>
        <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
        <group_list>
          <group group_id="O1">
            <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
            <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months</title>
          <description>Total ghrelin will be measured by a radioimmunoassay technique.</description>
          <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting and Peak Postprandial Glucagon-like Peptide-1 (GLP-1) at 3 Months</title>
        <description>Glucagon-like peptide-1 (GLP-1) will be measured by a radioimmunoassay technique.</description>
        <time_frame>baseline, 90 minutes postprandially</time_frame>
        <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
        <group_list>
          <group group_id="O1">
            <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
            <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting and Peak Postprandial Glucagon-like Peptide-1 (GLP-1) at 3 Months</title>
          <description>Glucagon-like peptide-1 (GLP-1) will be measured by a radioimmunoassay technique.</description>
          <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months</title>
        <description>Peptide Tyrosine Tyrosine (PYY) will be measured by radioimmunoassay.</description>
        <time_frame>baseline, 90 minutes postprandially</time_frame>
        <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
        <group_list>
          <group group_id="O1">
            <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
            <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months</title>
          <description>Peptide Tyrosine Tyrosine (PYY) will be measured by radioimmunoassay.</description>
          <population>Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected up to 3 months for each subject</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Transcutaneous Electrical Nerve Stimulation (TENS)</title>
          <description>Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)&#xD;
Transcutaneous electrical nerve stimulation (TENS): Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.</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="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
              </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="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Michael Camilleri, M.D.</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-2687</phone>
      <email>camilleri.michael@mayo.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/NCT03261531
org study id: 16-001916
nct id: NCT03261531
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Investigators are doing this research study to find out the effect of T6 dermatomal
      electrical stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS)
      unit) on appetite and weight loss.
Participants will be treated before and after two meals of the day with T6 dermatomal
      electrical stimulation delivered by a Transcutaneous Electrical Nerve Stimulation (TENS)
      unit. Participants will receive 15-minute T6 dermatome cutaneous stimulation with TENS unit
      applied immediately before ingestion of two of main meals of the day (breakfast and evening
      meal), and 60 minute stimulation applied immediately after ingestion of these meals.
      Participants will apply the stimulus four times daily for a treatment period of at least 3
      months. Participants will keep a diary of weight once weekly and a weekly appetite record.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in Body Weight
time frame: Baseline, 3 months
description: Change in body weight will be measured in kilograms or pounds
measure: Gastric Half-emptying Time (GE T 1/2)
time frame: After 1 day treatment (approximately at 4 hours)
description: The time for half of the ingested solids to leave the stomach
measure: Gastric Half-emptying Time (GE T 1/2)
time frame: At 3 months, approximately 2 hours after radiolabeled meal is ingested
description: The time for half of the ingested solids to leave the stomach
measure: Fasting Gastric Volume by 99mTc-SPECT Imaging
time frame: At 3 months, approx 20 minutes after 99mTC injection
description: A noninvasive SPECT method will be used to measure gastric volume. Subjects will report to the clinic after an overnight fast. The first fasting scan will be obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.
measure: Postprandial Gastric Volume (Gastric Accommodation) by 99mTc-SPECT Imaging
time frame: At 3 months, approximately 30 min after liquid meal
description: A noninvasive SPECT method will be used to measure gastric volume after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC will be given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.
measure: Change in Gastric Emptying Percentage
time frame: Day 1, 3 months
description: The time for gastric retention of ingested solids or liquid to leave the stomach, measured in percentage.
measure: Satiation Volume (Level 3)
time frame: Approximately 30 minutes after the liquid meal
description: Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal ("volume to fullness"), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.
measure: Satiation Maximum Tolerated Volume (Level 5)
time frame: Approximately 30 minutes after the liquid meal
description: Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal ("volume to fullness"), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.
measure: Mean Kcal Intake at Buffet Meal as a Measure of Appetite
time frame: At 3 months, approximately 30 minutes after the buffet meal
description: Assessment of kcal intake as a measure of appetite buffet meal to measure total caloric intake. 5 hours after ingesting 300 mL liquid nutrient as part of the gastric volume study, participants will be invited to eat, during a 30-minute period, a standard "free feeding" meal. The total amount of food consumed will be analyzed by the study dietitian.
measure: Change in Appetite Score
time frame: Baseline, 3 months
description: Ratings of appetite will be measured every 30 minutes between the time of ingestion of standard liquid breakfast and the start of the ad libitum meal. The appetite rating will be measured by 4- 100 mm long Visual Analog Scales (VAS). The VAS does not have any pre-set marks between the extremes of 0 for negative rating and 100 mm for positive rating. The investigator measures the mark made by the participant in mm and records this for the value. The overall appetite score will be calculated as the average of the four individual scores (satiety + fullness+100-prospective food consumption + hunger/4.
measure: Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months
time frame: baseline, 90 minutes postprandially
description: Total ghrelin will be measured by a radioimmunoassay technique.
measure: Change in Fasting and Peak Postprandial Glucagon-like Peptide-1 (GLP-1) at 3 Months
time frame: baseline, 90 minutes postprandially
description: Glucagon-like peptide-1 (GLP-1) will be measured by a radioimmunoassay technique.
measure: Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months
time frame: baseline, 90 minutes postprandially
description: Peptide Tyrosine Tyrosine (PYY) will be measured by radioimmunoassay.
arm group label: Transcutaneous electrical nerve stimulation (TENS)
arm group type: Experimental
description: Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)
intervention type: Device
intervention name: Transcutaneous electrical nerve stimulation (TENS)
description: Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
arm group label: Transcutaneous electrical nerve stimulation (TENS)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Michael Camilleri, M.D
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Michael Camilleri, MD
investigator title: Principal Investigator
mesh term: Obesity
mesh term: Overweight
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 