<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/NCT04417816</url>
  </required_header>
  <id_info>
    <org_study_id>UATC-001</org_study_id>
    <nct_id>NCT04417816</nct_id>
  </id_info>
  <brief_title>Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity</brief_title>
  <acronym>UATC</acronym>
  <official_title>Ultrasound-induced Adipose Tissue Cavitation: Effects on Cardiometabolic Risk and Body Composition in Persons With Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hasselt 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>
      The addition of ultrasound-induced adipose tissue cavitation (UATC) at the level of the&#xD;
      abdominal subcutaneous adipose tissue may seem relevant as an additive treatment option to&#xD;
      exercise intervention in individuals with obesity. However, whether individuals with obesity&#xD;
      who participate in an exercise intervention and additionally undergo UATC, are more likely to&#xD;
      develop a metabolically healthy phenotype, as opposed to subjects with obesity undergoing&#xD;
      exercise training or UATC only, remains to be studied. Therefore, the first aim of this study&#xD;
      is to examine the impact of combined UATC during exercise intervention on abdominal&#xD;
      subcutaneous and whole-body adipose tissue mass, quality of life and cardiometabolic risk in&#xD;
      individuals with abdominal obesity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    At the request of the Ethical Committee&#xD;
  </why_stopped>
  <start_date type="Actual">April 15, 2018</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DEXA scan</measure>
    <time_frame>baseline</time_frame>
    <description>Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DEXA scan</measure>
    <time_frame>week 12</time_frame>
    <description>Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting blood sample</measure>
    <time_frame>Baseline</time_frame>
    <description>(glycated haemoglobin)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fasting blood sample</measure>
    <time_frame>week 12</time_frame>
    <description>(glycated haemoglobin)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lipid profile</measure>
    <time_frame>Baseline</time_frame>
    <description>total LDL, HDL, triglycerides</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lipid profile</measure>
    <time_frame>week 12</time_frame>
    <description>total LDL, HDL, triglycerides</description>
  </primary_outcome>
  <primary_outcome>
    <measure>kidney function</measure>
    <time_frame>Baseline</time_frame>
    <description>urea, creatinine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>kidney function</measure>
    <time_frame>week 12</time_frame>
    <description>urea, creatinine</description>
  </primary_outcome>
  <primary_outcome>
    <measure>inflammation</measure>
    <time_frame>Baseline</time_frame>
    <description>CRP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>inflammation</measure>
    <time_frame>week 12</time_frame>
    <description>CRP</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bloodpressure</measure>
    <time_frame>Baseline</time_frame>
    <description>systolic and diastolic blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bloodpressure</measure>
    <time_frame>Week 12</time_frame>
    <description>systolic and diastolic blood pressure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>oral glucose tolerance test</measure>
    <time_frame>Baseline</time_frame>
    <description>glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load</description>
  </primary_outcome>
  <primary_outcome>
    <measure>oral glucose tolerance test</measure>
    <time_frame>week 12</time_frame>
    <description>glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall physical fitness</measure>
    <time_frame>Baseline</time_frame>
    <description>Maximal oxygen uptake (during cardiopulmonary exercise testing)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall physical fitness</measure>
    <time_frame>week 12</time_frame>
    <description>Maximal oxygen uptake (during cardiopulmonary exercise testing)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall physical fitness</measure>
    <time_frame>Baseline</time_frame>
    <description>Maximal resistance (during cardiopulmonary exercise testing)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall physical fitness</measure>
    <time_frame>week 12</time_frame>
    <description>Maximal resistance (during cardiopulmonary exercise testing)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall physical fitness</measure>
    <time_frame>Baseline</time_frame>
    <description>Maximal heart rate (measured by electrocardiogram)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall physical fitness</measure>
    <time_frame>week 12</time_frame>
    <description>Maximal heart rate (measured by electrocardiogram)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 questionaire</measure>
    <time_frame>Baseline</time_frame>
    <description>Quality of Life questionaire, a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36 questionaire</measure>
    <time_frame>week 12</time_frame>
    <description>Quality of Life questionaire, a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food intake</measure>
    <time_frame>Baseline</time_frame>
    <description>3-day food diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food intake</measure>
    <time_frame>week 12</time_frame>
    <description>3-day food diary</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Exercise training + adipose tissue cavitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise training + sham procedure</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise training intervention with ultrasound induced adipose tissue cavitation</intervention_name>
    <description>Exercise training intervention with ultrasound induced adipose tissue cavitation</description>
    <arm_group_label>Exercise training + adipose tissue cavitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise training intervention without ultrasound induced adipose tissue cavitation</intervention_name>
    <description>Exercise training intervention with ultrasound induced adipose tissue cavitation</description>
    <arm_group_label>Exercise training + sham procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male/female (1:1),&#xD;
&#xD;
          -  age 18-65 y,&#xD;
&#xD;
          -  abdominal obesity (waist circumference &gt;102cm or &gt;88cm) -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  involvement in dietary or exercise intervention in the last year,&#xD;
&#xD;
          -  intake of any medication,&#xD;
&#xD;
          -  clinically diagnosed diseases (cardiovascular disease, hypertension, venous thromboses&#xD;
             blood diseases, presence of a pacemaker/defibrillator, brain or nervous system&#xD;
             diseases, kidney, thyroid or liver disease, chronic inflammatory diseases, cancer,&#xD;
             osteoporosis and epilepsy).&#xD;
&#xD;
          -  Persons with a pregnancy,&#xD;
&#xD;
          -  a recent bone injury or the presence of a metal prothese&#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>Dominique Hansen, prof. dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hasselt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kenneth Verboven, dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Hasselt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hasselt University</name>
      <address>
        <city>Diepenbeek</city>
        <zip>3590</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>August 24, 2021</last_update_submitted>
  <last_update_submitted_qc>August 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>Dominique Hansen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <!-- 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/NCT04417816
org study id: UATC-001
nct id: NCT04417816
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The addition of ultrasound-induced adipose tissue cavitation (UATC) at the level of the
      abdominal subcutaneous adipose tissue may seem relevant as an additive treatment option to
      exercise intervention in individuals with obesity. However, whether individuals with obesity
      who participate in an exercise intervention and additionally undergo UATC, are more likely to
      develop a metabolically healthy phenotype, as opposed to subjects with obesity undergoing
      exercise training or UATC only, remains to be studied. Therefore, the first aim of this study
      is to examine the impact of combined UATC during exercise intervention on abdominal
      subcutaneous and whole-body adipose tissue mass, quality of life and cardiometabolic risk in
      individuals with abdominal obesity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: DEXA scan
time frame: baseline
description: Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)
measure: DEXA scan
time frame: week 12
description: Body composition (fat mass, fat free mass, android and gynoid fat mass), clinical measures (waist circumference, hip circumference, weight, height)
measure: Fasting blood sample
time frame: Baseline
description: (glycated haemoglobin)
measure: Fasting blood sample
time frame: week 12
description: (glycated haemoglobin)
measure: lipid profile
time frame: Baseline
description: total LDL, HDL, triglycerides
measure: lipid profile
time frame: week 12
description: total LDL, HDL, triglycerides
measure: kidney function
time frame: Baseline
description: urea, creatinine
measure: kidney function
time frame: week 12
description: urea, creatinine
measure: inflammation
time frame: Baseline
description: CRP
measure: inflammation
time frame: week 12
description: CRP
measure: Bloodpressure
time frame: Baseline
description: systolic and diastolic blood pressure
measure: Bloodpressure
time frame: Week 12
description: systolic and diastolic blood pressure
measure: oral glucose tolerance test
time frame: Baseline
description: glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load
measure: oral glucose tolerance test
time frame: week 12
description: glucose and insulin levels at 0, 15, 30, 45, 60, 90 and 120 min post glucose load
measure: Overall physical fitness
time frame: Baseline
description: Maximal oxygen uptake (during cardiopulmonary exercise testing)
measure: Overall physical fitness
time frame: week 12
description: Maximal oxygen uptake (during cardiopulmonary exercise testing)
measure: Overall physical fitness
time frame: Baseline
description: Maximal resistance (during cardiopulmonary exercise testing)
measure: Overall physical fitness
time frame: week 12
description: Maximal resistance (during cardiopulmonary exercise testing)
measure: Overall physical fitness
time frame: Baseline
description: Maximal heart rate (measured by electrocardiogram)
measure: Overall physical fitness
time frame: week 12
description: Maximal heart rate (measured by electrocardiogram)
measure: SF-36 questionaire
time frame: Baseline
description: Quality of Life questionaire, a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status
measure: SF-36 questionaire
time frame: week 12
description: Quality of Life questionaire, a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status
measure: Food intake
time frame: Baseline
description: 3-day food diary
measure: Food intake
time frame: week 12
description: 3-day food diary
arm group label: Exercise training + adipose tissue cavitation
arm group type: Experimental
arm group label: Exercise training + sham procedure
arm group type: Sham Comparator
intervention type: Other
intervention name: Exercise training intervention with ultrasound induced adipose tissue cavitation
description: Exercise training intervention with ultrasound induced adipose tissue cavitation
arm group label: Exercise training + adipose tissue cavitation
intervention type: Other
intervention name: Exercise training intervention without ultrasound induced adipose tissue cavitation
description: Exercise training intervention with ultrasound induced adipose tissue cavitation
arm group label: Exercise training + sham procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dominique Hansen, prof. dr.
role: Principal Investigator
affiliation: Hasselt University
last name: Kenneth Verboven, dr.
role: Study Chair
affiliation: Hasselt University
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: Dominique Hansen
investigator title: Principal Investigator
mesh term: Obesity