<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/NCT03241394</url>
  </required_header>
  <id_info>
    <org_study_id>802</org_study_id>
    <nct_id>NCT03241394</nct_id>
  </id_info>
  <brief_title>The Monocyte Subsets in Obese Patients With and Without Metabolic Syndrome</brief_title>
  <official_title>The Investigation of the Role of Inflammation in the Insulin Resistance Syndrome: The Monocyte Subsets in Obese Patients With and Without Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ioannina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ioannina</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>
      Obesity is associated with a chronic low-grade inflammation characterized by macrophage&#xD;
      infiltration in adipose tissue that induces insulin resistance and the appearance of&#xD;
      metabolic syndrome (MS). The aim of the study was the investigation of whether circulating&#xD;
      monocyte subsets are differentially regulated in MS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Anticipated">September 15, 2017</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Monocyte subsets</measure>
    <time_frame>Baseline measurement</time_frame>
    <description>Absolute blood count of classical (Mon1A), intermediate (Mon2A) and nonclassical (Mon3A) monocyte subsets wil be measured by flow cytometry.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Obesity</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Lean</arm_group_label>
    <description>Individuals with Body Mass Index (BMI) = 18.5 - 25.0 Kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese with MS</arm_group_label>
    <description>Individuals with BMI ≥ 30.0 Kg/m2 and metabolic syndrome (MS) MS was defined as the presence of three or more of the following criteria: 1) waist circumference ≥ 102 cm in men and ≥ 88 cm in women, 2) serum triglycerides ≥ 150 mg/dL, 3) high density lipoprotein-cholesterol (HDL-C) &lt; 40 mg/dl in men and &lt; 50 mg/dl in women, 4) systolic blood pressure (SBP) ≥ 130 mmHg or diastolic blood pressure (DBP) ≥ 85 mmHg or antihypertensive drug treatment, 5) fasting glucose ≥ 100 mg/dL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese without MS</arm_group_label>
    <description>Individuals with BMI ≥ 30.0 Kg/m2 but not MS</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        In the present study healthy lean volunteers and obese subjects were recruited. The obese&#xD;
        patients attended the Endocrinology outpatient clinic of the University Hospital of&#xD;
        Ioannina in Greece. The obese patients were either with metabolic syndrome (MS) or without&#xD;
        MS.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Age less than 18 years old, pregnancy, breast feeding, kidney disease, liver disease,&#xD;
        gastrointestinal disease, malignancy, any endocrine disorder or metabolic disease, other&#xD;
        than obesity or type 2 diabetes mellitus (T2DM), alteration of body weight (BW) by up of 5%&#xD;
        of the initial BW during the last 3 months, any state of stress or systemic inflammation&#xD;
        and taking any of the following drugs, within 3 weeks prior to the start of the study:&#xD;
        hypolipidemic agents, antidiabetics, drugs for weight loss, nonsteroidal antiinflammatory&#xD;
        drugs, glucocorticoids.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital of Ioannina</name>
      <address>
        <city>Ioánnina</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stelios Tigas, Prof.</last_name>
      <phone>0030 6978642944</phone>
      <email>stigas@cc.uoi.gr</email>
    </contact>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>August 2, 2017</last_update_submitted>
  <last_update_submitted_qc>August 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Ioannina</investigator_affiliation>
    <investigator_full_name>Georgios A. Christou</investigator_full_name>
    <investigator_title>Cardiologist, Postdoctoral researcher</investigator_title>
  </responsible_party>
  <keyword>Monocyte subsets</keyword>
  <keyword>Obesity</keyword>
  <keyword>Metabolic Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT03241394
org study id: 802
nct id: NCT03241394
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Obesity is associated with a chronic low-grade inflammation characterized by macrophage
      infiltration in adipose tissue that induces insulin resistance and the appearance of
      metabolic syndrome (MS). The aim of the study was the investigation of whether circulating
      monocyte subsets are differentially regulated in MS.
observational model: Other
time perspective: Cross-Sectional
measure: Monocyte subsets
time frame: Baseline measurement
description: Absolute blood count of classical (Mon1A), intermediate (Mon2A) and nonclassical (Mon3A) monocyte subsets wil be measured by flow cytometry.
arm group label: Lean
description: Individuals with Body Mass Index (BMI) = 18.5 - 25.0 Kg/m2
arm group label: Obese with MS
description: Individuals with BMI ≥ 30.0 Kg/m2 and metabolic syndrome (MS) MS was defined as the presence of three or more of the following criteria: 1) waist circumference ≥ 102 cm in men and ≥ 88 cm in women, 2) serum triglycerides ≥ 150 mg/dL, 3) high density lipoprotein-cholesterol (HDL-C) < 40 mg/dl in men and < 50 mg/dl in women, 4) systolic blood pressure (SBP) ≥ 130 mmHg or diastolic blood pressure (DBP) ≥ 85 mmHg or antihypertensive drug treatment, 5) fasting glucose ≥ 100 mg/dL
arm group label: Obese without MS
description: Individuals with BMI ≥ 30.0 Kg/m2 but not MS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Ioannina
investigator full name: Georgios A. Christou
investigator title: Cardiologist, Postdoctoral researcher
mesh term: Metabolic Syndrome
mesh term: Syndrome