<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/NCT04437979</url>
  </required_header>
  <id_info>
    <org_study_id>2019-397</org_study_id>
    <nct_id>NCT04437979</nct_id>
  </id_info>
  <brief_title>Epicardial Fat Thickness and Inflammation in People With Metabolic Syndrome and Obesity</brief_title>
  <official_title>Association of Epicardial Fat Thickness and Inflammation With the Presence of Metabolic Syndrome in People With Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Antalya Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Antalya Training and Research Hospital</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>
      Epicardial adipose tissue (EAT) is a type of visceral adipose tissue (VAT), functioning as a&#xD;
      metabolically active endocrine organ and suggested to play an important role in the&#xD;
      progression of metabolic syndrome (MetS). Obesity and MetS are commonly associated with an&#xD;
      inflammatory status. The aim of the study was to evaluate the association of&#xD;
      echocardiographically measured epicardial fat thickness (EFT) and inflammation, on the basis&#xD;
      of c-reactive protein (CRP) and neutrophil-lymphocyte ratio (NLR), with MetS and its&#xD;
      components in people with obesity.&#xD;
&#xD;
      A total of 104 patients with body mass index (BMI)≥30 kg/m² were enrolled to the study. In&#xD;
      all participants, EFT was measured with transthoracic echocardiography at end-systole. The&#xD;
      patients were then classified into two groups according to whether they had MetS or not. EFT,&#xD;
      clinical and biochemical parameters were compared between the two groups&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Epicardial adipose tissue (EAT) is a kind of VAT, between the surface of the myocardium and&#xD;
      the epicardium. It can easily be measured by standard two-dimensional (2D) echocardiography.&#xD;
      EAT serves as an endocrin organ that secretes hormones, inflammatory cytokines and&#xD;
      chemokines. Previous data suggests that EAT can play an active role in the development of&#xD;
      metabolic syndrome (MetS). Previous studies have investigated the relationship between&#xD;
      EAT/inflammatory markers and MetS/MetS components. However, there was lack of enough evidence&#xD;
      regarding this relationship in people with obesity with or without MetS. The aim of the&#xD;
      present study was to evaluate the association of echocardiographically measured EAT and&#xD;
      inflammation, on the basis of c-reactive protein (CRP) and neutrophil-lymphocyte ratio (NLR),&#xD;
      as simple and reliable indicators of inflammation, with MetS and its components in people&#xD;
      with obesity who have similar body mass index (BMI) values. In this cross-sectional study,&#xD;
      104 consecutive patients with BMI ≥30 kg/m2 who presented to the 'Obesity Solution Center 'of&#xD;
      Antalya Research and Training Hospital were included . Patients with manifest heart disease&#xD;
      such as, coronary heart disease, cardiac failure, cardiac valve disease or arrythmia, renal&#xD;
      failure, hepatic failure, infection, chronic systemic inflammatory disease, pulmonary disease&#xD;
      , malignancy and inadequate transthoracic echocardiographic images were excluded. The study&#xD;
      protocol was approved by the local ethics committee and informed consent was obtained from&#xD;
      each subject.&#xD;
&#xD;
      Clinical information and current cardiovascular medication use were provided from each&#xD;
      patient. Height, weight, waist circumference and hip circumference (HC) were measured when&#xD;
      fasting and standing up with standard measuring tools. Patients were defined as having&#xD;
      hypertension (HT) if their systolic blood pressure was &gt;140 mmHg, their diastolic blood&#xD;
      pressure was &gt;90 mmHg, or they were using an antihypertensive medication. Blood samples were&#xD;
      obtained after overnight fasting. Fasting blood glucose, urea, creatinine, total cholesterol,&#xD;
      low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol,&#xD;
      triglycerides, CRP, fasting and postprandial insulin, C-peptid levels, vitamin D, ferritin&#xD;
      and complete blood counts were measured using standard methods. Homeostasis model assessment&#xD;
      of insulin resistance (HOMA-IR) was calculated using the method described by Matthews et al.&#xD;
      NLR was defined as the log e neutrophil count/log e lymphocyte count within the peripheral&#xD;
      blood. Patients were defined as having diabetes mellitus (DM) if they had a history of taking&#xD;
      an oral antidiabetic or insulin medication, or if their fasting plasma glucose was ≥ 126&#xD;
      mg/dl. The patients were classified into two groups according to whether they had MetS or&#xD;
      not. MetS was diagnosed according to the National Cholesterol Education Programme Adult&#xD;
      Treatment Panel III (NCEP ATP III). Epicardial fat thickness (EFT) was identified as the&#xD;
      echo-free space in the pericardial layers on 2D echocardiography. EFT was measured on the&#xD;
      free wall of the right ventricle at end-systole from both parasternal long axis and&#xD;
      parasternal short axis views using the mean of three consecutive beats.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Estimation of the epicardial fat thickness in the presence of metabolic syndrome in people with obesity</measure>
    <time_frame>1 week</time_frame>
    <description>Transthoracic echocardiography was performed to all participants with body mass index &gt; 30 kg/m2 and epicardial fat thickness was measured. Epicardial fat thickness (EFT) was identified as the echo-free space in the pericardial layers on 2D echocardiography. EFT was measured on the free wall of the right ventricle at end-systole from both parasternal long axis and parasternal short axis views using the mean of three consecutive beats The patients were classified into two groups according to whether they had MetS or not. MetS was diagnosed according to the National Cholesterol Education Programme Adult Treatment Panel III. We evaluated the difference in epicardial fat thickness according to whether having metabolic syndrome or not, regardless of body mass index.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimation of inflammation in the presence of metabolic syndrome in people with obesity</measure>
    <time_frame>1 week</time_frame>
    <description>C-reactive protein and neutrophil-to-lymphocyte ratio were used to determine inflammation. The patients were classified into two groups according to whether they had MetS or not. MetS was diagnosed according to the National Cholesterol Education Programme Adult Treatment Panel III. We evaluated the difference in inflammatory mediators according to whether having metabolic syndrome or not, regardless of body mass index.</description>
  </secondary_outcome>
  <enrollment type="Actual">104</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Obesity</condition>
  <condition>Inflammation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with BMI ≥30 kg/m2, &gt;18 years old and without manifest heart disease such as,&#xD;
        coronary heart disease, cardiac failure, cardiac valve disease or arrythmia, renal failure,&#xD;
        hepatic failure, infection, chronic systemic inflammatory disease, pulmonary disease and&#xD;
        malignancy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Having body mass index ≥30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:.&#xD;
&#xD;
          -  Manifest heart disease ( coronary heart disease, cardiac failure, cardiac valve&#xD;
             disease or arrythmia)&#xD;
&#xD;
          -  Renal failure&#xD;
&#xD;
          -  Hepatic failure&#xD;
&#xD;
          -  Infection&#xD;
&#xD;
          -  Chronic systemic inflammatory disease&#xD;
&#xD;
          -  Pulmonary disease&#xD;
&#xD;
          -  Malignancy&#xD;
&#xD;
          -  Inadequate transthoracic echocardiographic images&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Duygu Ersan Demirci, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Antalya Research and Training Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Antalya Research and Training Hospital</name>
      <address>
        <city>Antalya</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>August 19, 2020</last_update_submitted>
  <last_update_submitted_qc>August 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Antalya Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Duygu Ersan Demirci</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>epicardial fat thickness</keyword>
  <keyword>metabolic syndrome</keyword>
  <keyword>obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Inflammation</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/NCT04437979
org study id: 2019-397
nct id: NCT04437979
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Epicardial adipose tissue (EAT) is a type of visceral adipose tissue (VAT), functioning as a
      metabolically active endocrine organ and suggested to play an important role in the
      progression of metabolic syndrome (MetS). Obesity and MetS are commonly associated with an
      inflammatory status. The aim of the study was to evaluate the association of
      echocardiographically measured epicardial fat thickness (EFT) and inflammation, on the basis
      of c-reactive protein (CRP) and neutrophil-lymphocyte ratio (NLR), with MetS and its
      components in people with obesity.

      A total of 104 patients with body mass index (BMI)≥30 kg/m² were enrolled to the study. In
      all participants, EFT was measured with transthoracic echocardiography at end-systole. The
      patients were then classified into two groups according to whether they had MetS or not. EFT,
      clinical and biochemical parameters were compared between the two groups
Epicardial adipose tissue (EAT) is a kind of VAT, between the surface of the myocardium and
      the epicardium. It can easily be measured by standard two-dimensional (2D) echocardiography.
      EAT serves as an endocrin organ that secretes hormones, inflammatory cytokines and
      chemokines. Previous data suggests that EAT can play an active role in the development of
      metabolic syndrome (MetS). Previous studies have investigated the relationship between
      EAT/inflammatory markers and MetS/MetS components. However, there was lack of enough evidence
      regarding this relationship in people with obesity with or without MetS. The aim of the
      present study was to evaluate the association of echocardiographically measured EAT and
      inflammation, on the basis of c-reactive protein (CRP) and neutrophil-lymphocyte ratio (NLR),
      as simple and reliable indicators of inflammation, with MetS and its components in people
      with obesity who have similar body mass index (BMI) values. In this cross-sectional study,
      104 consecutive patients with BMI ≥30 kg/m2 who presented to the 'Obesity Solution Center 'of
      Antalya Research and Training Hospital were included . Patients with manifest heart disease
      such as, coronary heart disease, cardiac failure, cardiac valve disease or arrythmia, renal
      failure, hepatic failure, infection, chronic systemic inflammatory disease, pulmonary disease
      , malignancy and inadequate transthoracic echocardiographic images were excluded. The study
      protocol was approved by the local ethics committee and informed consent was obtained from
      each subject.

      Clinical information and current cardiovascular medication use were provided from each
      patient. Height, weight, waist circumference and hip circumference (HC) were measured when
      fasting and standing up with standard measuring tools. Patients were defined as having
      hypertension (HT) if their systolic blood pressure was >140 mmHg, their diastolic blood
      pressure was >90 mmHg, or they were using an antihypertensive medication. Blood samples were
      obtained after overnight fasting. Fasting blood glucose, urea, creatinine, total cholesterol,
      low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol,
      triglycerides, CRP, fasting and postprandial insulin, C-peptid levels, vitamin D, ferritin
      and complete blood counts were measured using standard methods. Homeostasis model assessment
      of insulin resistance (HOMA-IR) was calculated using the method described by Matthews et al.
      NLR was defined as the log e neutrophil count/log e lymphocyte count within the peripheral
      blood. Patients were defined as having diabetes mellitus (DM) if they had a history of taking
      an oral antidiabetic or insulin medication, or if their fasting plasma glucose was ≥ 126
      mg/dl. The patients were classified into two groups according to whether they had MetS or
      not. MetS was diagnosed according to the National Cholesterol Education Programme Adult
      Treatment Panel III (NCEP ATP III). Epicardial fat thickness (EFT) was identified as the
      echo-free space in the pericardial layers on 2D echocardiography. EFT was measured on the
      free wall of the right ventricle at end-systole from both parasternal long axis and
      parasternal short axis views using the mean of three consecutive beats.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Estimation of the epicardial fat thickness in the presence of metabolic syndrome in people with obesity
time frame: 1 week
description: Transthoracic echocardiography was performed to all participants with body mass index > 30 kg/m2 and epicardial fat thickness was measured. Epicardial fat thickness (EFT) was identified as the echo-free space in the pericardial layers on 2D echocardiography. EFT was measured on the free wall of the right ventricle at end-systole from both parasternal long axis and parasternal short axis views using the mean of three consecutive beats The patients were classified into two groups according to whether they had MetS or not. MetS was diagnosed according to the National Cholesterol Education Programme Adult Treatment Panel III. We evaluated the difference in epicardial fat thickness according to whether having metabolic syndrome or not, regardless of body mass index.
measure: Estimation of inflammation in the presence of metabolic syndrome in people with obesity
time frame: 1 week
description: C-reactive protein and neutrophil-to-lymphocyte ratio were used to determine inflammation. The patients were classified into two groups according to whether they had MetS or not. MetS was diagnosed according to the National Cholesterol Education Programme Adult Treatment Panel III. We evaluated the difference in inflammatory mediators according to whether having metabolic syndrome or not, regardless of body mass index.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Duygu Ersan Demirci, MD
role: Principal Investigator
affiliation: Antalya Research and Training Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Antalya Training and Research Hospital
investigator full name: Duygu Ersan Demirci
investigator title: Principal investigator
mesh term: Obesity
mesh term: Metabolic Syndrome
mesh term: Syndrome
mesh term: Inflammation