<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/NCT03767608</url>
  </required_header>
  <id_info>
    <org_study_id>AIEMPPDM2SM</org_study_id>
    <nct_id>NCT03767608</nct_id>
  </id_info>
  <brief_title>Association Between Irisin, Inflammatory Markers and Metabolic Status in Obese Children With Type 2 Diabetes Mellitus</brief_title>
  <official_title>Association Between Irisin, Inflammatory Markers and Metabolic Status in Obese Children With Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Tecnologico y de Estudios Superiores de Monterey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Tecnologico y de Estudios Superiores de Monterey</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 objective of this study was to investigate the association of irisin with inflammatory&#xD;
      markers as well with metabolic and anthropometric parameters in children and adolescents with&#xD;
      type 2 diabetes mellitus compared with healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mexican children and adolescents previously diagnosed with type 2 diabetes mellitus according&#xD;
      to the American Diabetes Association (ADA) criteria were recruited and compared to healthy&#xD;
      controls.&#xD;
&#xD;
      The participants will undergo:&#xD;
&#xD;
        -  vital signs measurement (systolic and diastolic blood pressure, heart rate, respiratory&#xD;
           rate)&#xD;
&#xD;
        -  anthropometric variables measurement (BMI, weight, waist circumference, hip&#xD;
           circumference, body fat %)&#xD;
&#xD;
        -  laboratory studies: glucose, triglycerides, HDL-c, C reactive protein, irisin&#xD;
&#xD;
      After statistical analyses the investigators will compare the relationship of irisin and the&#xD;
      inflammatory profile and the anthropometric parameters of diabetic patients versus lean&#xD;
      controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of irisin levels and anthropometric parameters in children with type 2 diabetes mellitus (T2DM)</measure>
    <time_frame>1 day</time_frame>
    <description>Correlation of irisin levels and anthropometric parameters in children with T2DM</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of irisin levels and anthropometric parameters in healthy control children</measure>
    <time_frame>1 day</time_frame>
    <description>Correlation of irisin levels and anthropometric parameters in healthy control children</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of irisin levels and cytokines levels in children with T2DM</measure>
    <time_frame>1 day</time_frame>
    <description>Correlation of irisin levels and cytokines levels in children with T2DM</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of irisin levels and C reactive protein levels in healthy control children</measure>
    <time_frame>1 day</time_frame>
    <description>Correlation of irisin levels and C reactive protein levels in healthy control children</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison between groups</measure>
    <time_frame>1 day</time_frame>
    <description>Compare the correlations of irisin woth anthropometric parameters and INFLAMMATORY MARKERSbetween children diagnosed with T2DM and healthy controls</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Pediatric Obesity</condition>
  <arm_group>
    <arm_group_label>Patients with type 2 diabetes mellitus</arm_group_label>
    <description>Patients diagnosed with T2DM according to the ADA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lean healthy controls</arm_group_label>
    <description>Lean healthy controls</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum and plasma were obtained from blood samples and were stored at -80°C&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        40 Mexican children and adolescents aged 7-17 (20 boys and 20 girls) 20 children and&#xD;
        adolescents diagnosed with T2DM and 20 healthy controls&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Have been previously diagnosed with T2DM according to the American Diabetes Association&#xD;
        (ADA) criteria .&#xD;
&#xD;
        Healthy controls were required to have:&#xD;
&#xD;
          -  Normal weight according to the Centers for Disease Control and Prevention (CDC)&#xD;
             criteria.&#xD;
&#xD;
          -  No metabolic abnormalities on blood samples&#xD;
&#xD;
          -  No previously diagnosed cardiometabolic diseases&#xD;
&#xD;
          -  Not been using antihypertensive, lipid or glucose lowering medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disapproval by the children's physician due to any at-risk medical condition known by&#xD;
             the parents&#xD;
&#xD;
          -  Use of drugs for high blood pressure, hyperglycemia, or dyslipidemia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Leticia Elizondo-Montemayor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tecnologico de Monterrey, Escuela de Medicina y Ciencias de la Salud</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Nutrition and Obesity Research Center. School of Medicine, TEC Salud, Tecnológico de Monterrey</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo Leon</state>
        <zip>64710</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Tecnologico y de Estudios Superiores de Monterey</investigator_affiliation>
    <investigator_full_name>Leticia Elizondo-Montemayor</investigator_full_name>
    <investigator_title>Dean of the Clinical Nutrition and Obesity Research Center. School of Medicine TEC Salud. Tecnológico de Monterrey</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Pediatric 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/NCT03767608
org study id: AIEMPPDM2SM
nct id: NCT03767608
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study was to investigate the association of irisin with inflammatory
      markers as well with metabolic and anthropometric parameters in children and adolescents with
      type 2 diabetes mellitus compared with healthy controls.
Mexican children and adolescents previously diagnosed with type 2 diabetes mellitus according
      to the American Diabetes Association (ADA) criteria were recruited and compared to healthy
      controls.

      The participants will undergo:

        -  vital signs measurement (systolic and diastolic blood pressure, heart rate, respiratory
           rate)

        -  anthropometric variables measurement (BMI, weight, waist circumference, hip
           circumference, body fat %)

        -  laboratory studies: glucose, triglycerides, HDL-c, C reactive protein, irisin

      After statistical analyses the investigators will compare the relationship of irisin and the
      inflammatory profile and the anthropometric parameters of diabetic patients versus lean
      controls.
observational model: Cohort
time perspective: Cross-Sectional
measure: Correlation of irisin levels and anthropometric parameters in children with type 2 diabetes mellitus (T2DM)
time frame: 1 day
description: Correlation of irisin levels and anthropometric parameters in children with T2DM
measure: Correlation of irisin levels and anthropometric parameters in healthy control children
time frame: 1 day
description: Correlation of irisin levels and anthropometric parameters in healthy control children
measure: Correlation of irisin levels and cytokines levels in children with T2DM
time frame: 1 day
description: Correlation of irisin levels and cytokines levels in children with T2DM
measure: Correlation of irisin levels and C reactive protein levels in healthy control children
time frame: 1 day
description: Correlation of irisin levels and C reactive protein levels in healthy control children
measure: Comparison between groups
time frame: 1 day
description: Compare the correlations of irisin woth anthropometric parameters and INFLAMMATORY MARKERSbetween children diagnosed with T2DM and healthy controls
arm group label: Patients with type 2 diabetes mellitus
description: Patients diagnosed with T2DM according to the ADA
arm group label: Lean healthy controls
description: Lean healthy controls
Serum and plasma were obtained from blood samples and were stored at -80°C
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 17 Years
last name: Leticia Elizondo-Montemayor, MD
role: Principal Investigator
affiliation: Tecnologico de Monterrey, Escuela de Medicina y Ciencias de la Salud
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Instituto Tecnologico y de Estudios Superiores de Monterey
investigator full name: Leticia Elizondo-Montemayor
investigator title: Dean of the Clinical Nutrition and Obesity Research Center. School of Medicine TEC Salud. Tecnológico de Monterrey
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Pediatric Obesity