xml: <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/NCT06024018</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/003755</org_study_id>
      <nct_id>NCT06024018</nct_id>
    </id_info>
    <brief_title>Effect of High Intensity Electromagnetic Body Shaping on Profile of Metabolism in Obese Men</brief_title>
    <official_title>Efficacy of High Intensity Electromagnetic Body Shaping in Obese Men</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        high intensity focused electromagnetic technology's secondary effects are observed in the fat&#xD;
        (adipose). within 8 h of a treatment session, apoptotic levels in adipose increased 91.7%.8&#xD;
        In addition, after the application of the high intensity electromagnetic technique, there is&#xD;
        an increase in the rapid release of free fatty acids, so it can be used in weight loss&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        sixty obese males will be grouped to: first group (30 males) and second group (30 males).&#xD;
        first and second groups will undergo dietary caloric restriction (i.e low calorie diet) and&#xD;
        will be instructed to walk 10,000 continuous steps every day using the pedometer application&#xD;
        for 3 months. only the first group will will undergo high intensity electromagnetic technique&#xD;
        on abdomen of males which will be 3 sessions per week for 3 months&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2022</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>subcutaenous abdominal fat thickness</measure>
      <time_frame>12 weeks</time_frame>
      <description>it will be measured using ultrasonography</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>visceral abdominal fat thickness</measure>
      <time_frame>12 weeks</time_frame>
      <description>it will be measured using ultrasonography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>body mass index</measure>
      <time_frame>12 weeks</time_frame>
      <description>it will be measured at morning with empty stomach and bladder</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>waist circumference</measure>
      <time_frame>12 weeks</time_frame>
      <description>it will be measured using inelastic tape</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cortisol</measure>
      <time_frame>12 weeks</time_frame>
      <description>it is a stress hormone</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>high density lipoprotein</measure>
      <time_frame>12 weeks</time_frame>
      <description>it will be measured in serum</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>low density lipoprotein</measure>
      <time_frame>12 weeks</time_frame>
      <description>it will be measured in serum</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>triglycerides</measure>
      <time_frame>12 weeks</time_frame>
      <description>it will be measured in serum</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cholesterol</measure>
      <time_frame>12 weeks</time_frame>
      <description>it will be measured in serum</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>appearance of abdomen subscale of Body Q questionnaire</measure>
      <time_frame>12 weeks</time_frame>
      <description>BODY-Q provides a set of scales focusing on topics that are relevant to weight</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>health related-quality-of-life subscale of Body Q questionnaire</measure>
      <time_frame>12 weeks</time_frame>
      <description>it provids questions related to body image , physical function , psychological function , sexual function</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>eating related concerns subscale of Body Q questionnaire</measure>
      <time_frame>12 weeks</time_frame>
      <description>it provids questions related to eating behavior , expectations weight loss</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Central Obesity</condition>
    <arm_group>
      <arm_group_label>first group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>second group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>high intensity electromagnetic technology device, diet restriction, and walking</intervention_name>
      <description>thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months</description>
      <arm_group_label>first group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>diet restriction and walking</intervention_name>
      <description>thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months.</description>
      <arm_group_label>second group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  men with central obesity&#xD;
  &#xD;
            -  BMI 30-34.9 kg/m2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  metabolic /cardiovascular, pulmonary illnesses, musculoskeletal/neurological illness,&#xD;
               autoimmune/psychological illnesses&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>based on self-representation of gender identity.</gender_description>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ali MA Ismail, lecturer</last_name>
      <role>Study Director</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ali MA Ismail, lecturer</last_name>
      <phone>01005154209</phone>
      <email>ali.mohamed@pt.cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>ebtahal ATEF RAMADAN Afya</last_name>
      <phone>02 1024666329</phone>
      <email>dr.ebtehalpt@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cairo Unoversity</name>
        <address>
          <city>Giza</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ali Ismail, lecturer</last_name>
        <phone>01005154209</phone>
        <email>allooka2012@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>EBTEHAL ATEF RAMADAN AFYA</last_name>
        <phone>020 102 466 6329</phone>
        <email>dr.ebtehalpt@yahoo.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Ali Mohamed Ali ismail</investigator_full_name>
      <investigator_title>lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity, Abdominal</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024018
  org study id: P.T.REC/012/003755
  nct id: NCT06024018
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  high intensity focused electromagnetic technology's secondary effects are observed in the fat
        (adipose). within 8 h of a treatment session, apoptotic levels in adipose increased 91.7%.8
        In addition, after the application of the high intensity electromagnetic technique, there is
        an increase in the rapid release of free fatty acids, so it can be used in weight loss
  sixty obese males will be grouped to: first group (30 males) and second group (30 males).
        first and second groups will undergo dietary caloric restriction (i.e low calorie diet) and
        will be instructed to walk 10,000 continuous steps every day using the pedometer application
        for 3 months. only the first group will will undergo high intensity electromagnetic technique
        on abdomen of males which will be 3 sessions per week for 3 months
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: subcutaenous abdominal fat thickness
  time frame: 12 weeks
  description: it will be measured using ultrasonography
  measure: visceral abdominal fat thickness
  time frame: 12 weeks
  description: it will be measured using ultrasonography
  measure: body mass index
  time frame: 12 weeks
  description: it will be measured at morning with empty stomach and bladder
  measure: waist circumference
  time frame: 12 weeks
  description: it will be measured using inelastic tape
  measure: cortisol
  time frame: 12 weeks
  description: it is a stress hormone
  measure: high density lipoprotein
  time frame: 12 weeks
  description: it will be measured in serum
  measure: low density lipoprotein
  time frame: 12 weeks
  description: it will be measured in serum
  measure: triglycerides
  time frame: 12 weeks
  description: it will be measured in serum
  measure: cholesterol
  time frame: 12 weeks
  description: it will be measured in serum
  measure: appearance of abdomen subscale of Body Q questionnaire
  time frame: 12 weeks
  description: BODY-Q provides a set of scales focusing on topics that are relevant to weight
  measure: health related-quality-of-life subscale of Body Q questionnaire
  time frame: 12 weeks
  description: it provids questions related to body image , physical function , psychological function , sexual function
  measure: eating related concerns subscale of Body Q questionnaire
  time frame: 12 weeks
  description: it provids questions related to eating behavior , expectations weight loss
  arm group label: first group
  arm group type: Experimental
  description: thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months
  arm group label: second group
  arm group type: Active Comparator
  description: thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months.
  intervention type: Device
  intervention name: high intensity electromagnetic technology device, diet restriction, and walking
  description: thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months
  arm group label: first group
  intervention type: Behavioral
  intervention name: diet restriction and walking
  description: thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months.
  arm group label: second group
  criteria: 
  gender: Male
  gender based: Yes
  gender description: based on self-representation of gender identity.
  minimum age: 40 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Ali MA Ismail, lecturer
  role: Study Director
  affiliation: Cairo University
  last name: Ali MA Ismail, lecturer
  phone: 01005154209
  email: ali.mohamed@pt.cu.edu.eg
  last name: ebtahal ATEF RAMADAN Afya
  phone: 02 1024666329
  email: dr.ebtehalpt@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Ali Mohamed Ali ismail
  investigator title: lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University
  mesh term: Obesity, Abdominal