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/NCT06032312</url>
    </required_header>
    <id_info>
      <org_study_id>0799-20-TLV</org_study_id>
      <nct_id>NCT06032312</nct_id>
    </id_info>
    <brief_title>Metabolically Healthy Obese</brief_title>
    <acronym>MHO</acronym>
    <official_title>Phenotyping Metabolically Healthy Obese Adolescents</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tel-Aviv Sourasky Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tel-Aviv Sourasky Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Little is known about the associated factors and mechanisms involved in the development of&#xD;
        metabolic disturbance in pediatric obesity. The overall objective of the present study is to&#xD;
        investigate clinical, anthropometric, socio-demographic and lifestyle predictors of MHO among&#xD;
        obese children and adolescents. The Aim of the present study is to investigate the effect of&#xD;
        fat distribution, muscle mass, strength and physical activity level on metabolic morbidity in&#xD;
        obese adolescents.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The global epidemic of childhood obesity and the accompanying rise in the prevalence of&#xD;
        endocrine, metabolic, and cardiovascular comorbidities among the youth represents one of the&#xD;
        most important public health issues of the modern world. The earlier occurrence and increase&#xD;
        in the prevalence of both pediatric obesity and metabolic syndrome (MS) lead to a potential&#xD;
        decline in life expectancy such that the youth of today could be the first generation to live&#xD;
        shorter lives than their parents.&#xD;
  &#xD;
        In the context of the childhood obesity pandemic, a distinct subgroup of obese youth who are&#xD;
        less prone to the development of metabolic disturbances, termed &quot;metabolically healthy obese&quot;&#xD;
        (MHO), has recently been characterized. Despite their obese state, MHO individuals display a&#xD;
        &quot;favorable&quot; metabolic profile, with preserved insulin sensitivity, normal BP and glucose&#xD;
        regulation, normal lipid and liver enzyme levels, as well as a normal hormonal, inflammation&#xD;
        and immune profile. Although the MHO status might not necessarily translate into lower&#xD;
        mortality and can evolve into &quot;metabolically unhealthy obese&quot; (MUO) phenotype during puberty,&#xD;
        defining the MHO subpopulation among obese youth is critically important in order to&#xD;
        elucidate the mechanisms protecting against the clustering of cardiometabolic risk factors,&#xD;
        and their implications on clinical, preventive, and therapeutic decision-making.&#xD;
  &#xD;
        Only few studies have evaluated predictors and risk factors for MUO, and they were based on a&#xD;
        variety of definitions of MHO and the criteria used for defining it. Moreover, little is&#xD;
        known about the mechanisms of the development of metabolic disturbances in pediatric obesity.&#xD;
        More data are needed in order to identify the parameters most capable of predicting&#xD;
        clinically significant outcomes. In this research, the researchers aim to investigate&#xD;
        socio-demographic, clinical, anthropometric, physiological, and lifestyle predictors of MHO.&#xD;
  &#xD;
        Aim:&#xD;
  &#xD;
          1. To investigate socio-demographic, clinical, anthropometric, and lifestyle predictors for&#xD;
             MHO.&#xD;
  &#xD;
          2. To investigate the interaction between fat mass and distribution, muscle mass and&#xD;
             strength and physical activity level on metabolic morbidity in obese adolescents.&#xD;
  &#xD;
          3. To investigate the association between MHO predictors and metabolic disturbances.&#xD;
  &#xD;
        Study design:&#xD;
  &#xD;
        1. Patient Population This prospective observational, cross-sectional study will be performed&#xD;
        in the Nutrition and Obesity Clinic of the Pediatric Gastroenterology Unit at &quot;Dana Dwek&quot;&#xD;
        Children's Hospital and at the &quot;Gepner Lab&quot; at the Sackler Faculty of Medicine.&#xD;
  &#xD;
        Fifteen obese adolescents (age 12-18 years, body mass index [BMI] &gt;95th percentile) without&#xD;
        metabolic risk factors and fifteen obese adolescents (matched for BMI z-score, sex and age)&#xD;
        with 1 or more components of the metabolic syndrome will be recruited.&#xD;
  &#xD;
        Exclusion criteria: Adolescents with background diseases or past/current treatment with&#xD;
        medications that may influence body composition or metabolic risk (e.g., inflammatory&#xD;
        conditions).&#xD;
  &#xD;
        2 Data Collection&#xD;
  &#xD;
        The information that will be obtained from the medical files will include:&#xD;
  &#xD;
          1. Sociodemographic characteristics: sex, ethnicity, home address, number of children in&#xD;
             the family, household (single parent/two parent), parents' level of education.&#xD;
  &#xD;
          2. Medical history: perinatal characteristics (pregnancy, birth weight, gestational age,&#xD;
             feeding practice during the first year of life), age of adiposity rebound, medications,&#xD;
             menses (regular/irregular/oral contraceptives), sleep habits and family history of&#xD;
             cardiometabolic diseases (diabetes, hypertension, dyslipidemia, cardiovascular disease,&#xD;
             and cerebrovascular episodes) in first- and second-degree relatives.&#xD;
  &#xD;
          3. The obese children's perceptions of their motivation, health and social status will be&#xD;
             scored on a 1-10 scale and recorded at admission to the clinic.&#xD;
  &#xD;
        All participants will undergo a clinical evaluation that includes a physical examination,&#xD;
        systolic and diastolic BP and anthropometric measurements (height, weight, and calculated&#xD;
        BMI).&#xD;
  &#xD;
        CLINICAL AND METABOLIC ASSESSMENT Weight and height will be measured according to&#xD;
        standardized protocols. BMI percentiles will be computed by means of sex- and age- specific&#xD;
        BMI reference values from the Center for Disease Control and Prevention growth charts. Body&#xD;
        composition will be assessed with bioelectrical impedance. Laboratory and radiologic&#xD;
        parameters will include a liver enzyme profile, a lipid profile, glucose, insulin, HbA1c, and&#xD;
        C-reactive protein levels, and abdominal ultrasonography. The participants will be referred&#xD;
        for pelvic ultrasonography, polysomnography or an ophthalmologic evaluation if clinically&#xD;
        indicated.&#xD;
  &#xD;
        NUTRITIONAL ASSESSMENT The nutritional assessment will be based on an FFQ food report&#xD;
        administered by a registered dietician at study entry.&#xD;
  &#xD;
        BODY COMPOSITION ASSESSMENT&#xD;
  &#xD;
          1. Lean body mass and fat mass will be calculated by bioelectrical impedance analysis by&#xD;
             means of a multi-frequency SECA (mBCA 514 Medical) body composition analyzer. The&#xD;
             participants will be required to wear light clothing during the body composition&#xD;
             assessments and remove all jewelry, shoes, and socks. Measurements will be conducted in&#xD;
             the morning following an overnight fast.&#xD;
  &#xD;
          2. Abdominal adipose tissue distribution and liver fat will be assessed by MRI and MRS.&#xD;
  &#xD;
             Muscle function and physical activity Muscle strength and function will be measured by a&#xD;
             handgrip dynanometer. The participants will be asked to wear an accelerometer for 7 days&#xD;
             in order to measure their levels of physical activity and sleep habits.&#xD;
  &#xD;
          3. Definition of Study Variables Ethnicity will be defined as the birthplace of the parents&#xD;
             or grandparents (if the parents were born in Israel) and categorized according to&#xD;
             country of origin. Socioeconomic position will be determined by the patient's home&#xD;
             address according to the Israel Central Bureau of Statistics' Characterization and&#xD;
             Classification of Statistical Areas within Municipalities and Local Councils by the&#xD;
             Socio-Economic Level of the Population 2015&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 1, 2020</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Body composition (fat and fat free mass) of MHO</measure>
      <time_frame>1 day</time_frame>
      <description>body fat and fat free mass of MHO will be assessed by bioelectrical impedance</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Abdominal fat distribution using abdominal MRI</measure>
      <time_frame>3 days</time_frame>
      <description>Abdominal fat distribution will be assessed by abdominal MRI. a researchers will calculate the visceral and sub-cutanic fat volume</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dietary pattern in MHO</measure>
      <time_frame>1 day</time_frame>
      <description>Dietary pattern will be assessed by food frequency questioner that will asses consumption of dietary items (from once a day to less than once a month or never)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>physical activity of MHO</measure>
      <time_frame>3 days</time_frame>
      <description>physical activity be assessed by acetometer that will a measure walk distance per day</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Obesity</condition>
    <condition>Metabolic Syndrome</condition>
    <arm_group>
      <arm_group_label>1</arm_group_label>
      <description>metabolic healthy obese</description>
    </arm_group>
    <arm_group>
      <arm_group_label>2</arm_group_label>
      <description>metabolic unhealthy obese</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>description</intervention_name>
      <description>no intervention, just description of the groups</description>
      <arm_group_label>1</arm_group_label>
      <arm_group_label>2</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        blood samples for metabolic syndrome, abdominal MRI for liver fat&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          The study will be performed in the Nutrition and Obesity Clinic of the Pediatric&#xD;
          Gastroenterology Unit at &quot;Dana Dwek&quot; Children's Hospital.&#xD;
  &#xD;
          All children and adolescents that will be admitted to our clinic between December 2020 and&#xD;
          December 2024 will be included in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children aged 10-18 with obesity&#xD;
  &#xD;
            -  Attendance of the obesity clinic in the pediatric gastroenterology unit at &quot;Dana-Dwek&quot;&#xD;
               children's hospital, Tel Aviv Sourasky Medical Center.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children with congenital or acquired heart disease&#xD;
  &#xD;
            -  Children with inflammatory conditions&#xD;
  &#xD;
            -  Children with neurological conditions that affect body composition&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>10 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Hadar Moran Lev, MD</last_name>
      <phone>972527360713</phone>
      <email>hadarlev6@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tel Aviv medical center</name>
        <address>
          <city>Tel Aviv</city>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hadar Moran Lev, MD</last_name>
        <phone>972527360713</phone>
      </contact>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tel-Aviv Sourasky Medical Center</investigator_affiliation>
      <investigator_full_name>Eli Sprecher, MD</investigator_full_name>
      <investigator_title>Prof</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metabolic Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No Data will be shared by other researchers</ipd_description>
    </patient_data>
    <!-- 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/NCT06032312
  org study id: 0799-20-TLV
  nct id: NCT06032312
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Little is known about the associated factors and mechanisms involved in the development of
        metabolic disturbance in pediatric obesity. The overall objective of the present study is to
        investigate clinical, anthropometric, socio-demographic and lifestyle predictors of MHO among
        obese children and adolescents. The Aim of the present study is to investigate the effect of
        fat distribution, muscle mass, strength and physical activity level on metabolic morbidity in
        obese adolescents.
  The global epidemic of childhood obesity and the accompanying rise in the prevalence of
        endocrine, metabolic, and cardiovascular comorbidities among the youth represents one of the
        most important public health issues of the modern world. The earlier occurrence and increase
        in the prevalence of both pediatric obesity and metabolic syndrome (MS) lead to a potential
        decline in life expectancy such that the youth of today could be the first generation to live
        shorter lives than their parents.
  
        In the context of the childhood obesity pandemic, a distinct subgroup of obese youth who are
        less prone to the development of metabolic disturbances, termed "metabolically healthy obese"
        (MHO), has recently been characterized. Despite their obese state, MHO individuals display a
        "favorable" metabolic profile, with preserved insulin sensitivity, normal BP and glucose
        regulation, normal lipid and liver enzyme levels, as well as a normal hormonal, inflammation
        and immune profile. Although the MHO status might not necessarily translate into lower
        mortality and can evolve into "metabolically unhealthy obese" (MUO) phenotype during puberty,
        defining the MHO subpopulation among obese youth is critically important in order to
        elucidate the mechanisms protecting against the clustering of cardiometabolic risk factors,
        and their implications on clinical, preventive, and therapeutic decision-making.
  
        Only few studies have evaluated predictors and risk factors for MUO, and they were based on a
        variety of definitions of MHO and the criteria used for defining it. Moreover, little is
        known about the mechanisms of the development of metabolic disturbances in pediatric obesity.
        More data are needed in order to identify the parameters most capable of predicting
        clinically significant outcomes. In this research, the researchers aim to investigate
        socio-demographic, clinical, anthropometric, physiological, and lifestyle predictors of MHO.
  
        Aim:
  
          1. To investigate socio-demographic, clinical, anthropometric, and lifestyle predictors for
             MHO.
  
          2. To investigate the interaction between fat mass and distribution, muscle mass and
             strength and physical activity level on metabolic morbidity in obese adolescents.
  
          3. To investigate the association between MHO predictors and metabolic disturbances.
  
        Study design:
  
        1. Patient Population This prospective observational, cross-sectional study will be performed
        in the Nutrition and Obesity Clinic of the Pediatric Gastroenterology Unit at "Dana Dwek"
        Children's Hospital and at the "Gepner Lab" at the Sackler Faculty of Medicine.
  
        Fifteen obese adolescents (age 12-18 years, body mass index [BMI] >95th percentile) without
        metabolic risk factors and fifteen obese adolescents (matched for BMI z-score, sex and age)
        with 1 or more components of the metabolic syndrome will be recruited.
  
        Exclusion criteria: Adolescents with background diseases or past/current treatment with
        medications that may influence body composition or metabolic risk (e.g., inflammatory
        conditions).
  
        2 Data Collection
  
        The information that will be obtained from the medical files will include:
  
          1. Sociodemographic characteristics: sex, ethnicity, home address, number of children in
             the family, household (single parent/two parent), parents' level of education.
  
          2. Medical history: perinatal characteristics (pregnancy, birth weight, gestational age,
             feeding practice during the first year of life), age of adiposity rebound, medications,
             menses (regular/irregular/oral contraceptives), sleep habits and family history of
             cardiometabolic diseases (diabetes, hypertension, dyslipidemia, cardiovascular disease,
             and cerebrovascular episodes) in first- and second-degree relatives.
  
          3. The obese children's perceptions of their motivation, health and social status will be
             scored on a 1-10 scale and recorded at admission to the clinic.
  
        All participants will undergo a clinical evaluation that includes a physical examination,
        systolic and diastolic BP and anthropometric measurements (height, weight, and calculated
        BMI).
  
        CLINICAL AND METABOLIC ASSESSMENT Weight and height will be measured according to
        standardized protocols. BMI percentiles will be computed by means of sex- and age- specific
        BMI reference values from the Center for Disease Control and Prevention growth charts. Body
        composition will be assessed with bioelectrical impedance. Laboratory and radiologic
        parameters will include a liver enzyme profile, a lipid profile, glucose, insulin, HbA1c, and
        C-reactive protein levels, and abdominal ultrasonography. The participants will be referred
        for pelvic ultrasonography, polysomnography or an ophthalmologic evaluation if clinically
        indicated.
  
        NUTRITIONAL ASSESSMENT The nutritional assessment will be based on an FFQ food report
        administered by a registered dietician at study entry.
  
        BODY COMPOSITION ASSESSMENT
  
          1. Lean body mass and fat mass will be calculated by bioelectrical impedance analysis by
             means of a multi-frequency SECA (mBCA 514 Medical) body composition analyzer. The
             participants will be required to wear light clothing during the body composition
             assessments and remove all jewelry, shoes, and socks. Measurements will be conducted in
             the morning following an overnight fast.
  
          2. Abdominal adipose tissue distribution and liver fat will be assessed by MRI and MRS.
  
             Muscle function and physical activity Muscle strength and function will be measured by a
             handgrip dynanometer. The participants will be asked to wear an accelerometer for 7 days
             in order to measure their levels of physical activity and sleep habits.
  
          3. Definition of Study Variables Ethnicity will be defined as the birthplace of the parents
             or grandparents (if the parents were born in Israel) and categorized according to
             country of origin. Socioeconomic position will be determined by the patient's home
             address according to the Israel Central Bureau of Statistics' Characterization and
             Classification of Statistical Areas within Municipalities and Local Councils by the
             Socio-Economic Level of the Population 2015
  observational model: Case-Control
  time perspective: Prospective
  measure: Body composition (fat and fat free mass) of MHO
  time frame: 1 day
  description: body fat and fat free mass of MHO will be assessed by bioelectrical impedance
  measure: Abdominal fat distribution using abdominal MRI
  time frame: 3 days
  description: Abdominal fat distribution will be assessed by abdominal MRI. a researchers will calculate the visceral and sub-cutanic fat volume
  measure: Dietary pattern in MHO
  time frame: 1 day
  description: Dietary pattern will be assessed by food frequency questioner that will asses consumption of dietary items (from once a day to less than once a month or never)
  measure: physical activity of MHO
  time frame: 3 days
  description: physical activity be assessed by acetometer that will a measure walk distance per day
  arm group label: 1
  description: metabolic healthy obese
  arm group label: 2
  description: metabolic unhealthy obese
  intervention type: Other
  intervention name: description
  description: no intervention, just description of the groups
  arm group label: 1
  arm group label: 2
  blood samples for metabolic syndrome, abdominal MRI for liver fat
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 10 Years
  maximum age: 18 Years
  last name: Hadar Moran Lev, MD
  phone: 972527360713
  email: hadarlev6@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Israel
  responsible party type: Principal Investigator
  investigator affiliation: Tel-Aviv Sourasky Medical Center
  investigator full name: Eli Sprecher, MD
  investigator title: Prof
  mesh term: Metabolic Syndrome
  sharing ipd: No
  ipd description: No Data will be shared by other researchers