<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/NCT02978937</url>
  </required_header>
  <id_info>
    <org_study_id>2015E0155</org_study_id>
    <nct_id>NCT02978937</nct_id>
  </id_info>
  <brief_title>Obstructive Sleep Apnea and Metabolic Health</brief_title>
  <official_title>Obstrutive Sleep Apnea: is it a Biomarker of Metabolically Healthy vs. Unhealthy Obese</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational study involving chart review of patients seen in the bariatric&#xD;
      clinic since 2012 at The Ohio State University (OSU). Obese patients will be divided into two&#xD;
      groups according to their metabolic profile (healthy vs unhealthy). The assignment to each&#xD;
      group will be determined by the presence of diagnosis of hypertension, diabetes mellitus&#xD;
      and/or dyslipidemia. The presence of at least 2 diagnoses will be defined as metabolically&#xD;
      unhealthy. Then, each group will be divided based on the presence of Obstructive Sleep Apnea&#xD;
      diagnosis. All data will be collected through a review of the patient's electronic medical&#xD;
      record from the bariatric clinic database (the investigators will collect variables as age,&#xD;
      gender, race, BMI, smoking status, the presence of diagnosis as Obstructive sleep apnea,&#xD;
      hypertension, diabetes, hyperlipidemia). The investigators will analyze that data and&#xD;
      establish if there is any correlation between sleep apnea and the subjects' metabolic&#xD;
      profile.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obesity is associated with numerous metabolic complications including Type 2 diabetes&#xD;
      mellitus, hypertension, dyslipidemia, cardiovascular disease (CVD) and several forms of&#xD;
      cancer. However, the presence of these obesity-related metabolic abnormalities varies among&#xD;
      obese individuals. The phenotype of a metabolically healthy obese (MHO) individual was&#xD;
      initially described in 1980 and includes a subset of obese patients (as defined by BMI) who&#xD;
      do not manifest the typical metabolic abnormalities associated with obesity. Although results&#xD;
      are conflicting and highly dependent on patient population and diagnostic criteria for&#xD;
      metabolic health, these individuals tend to have a preserved level of insulin sensitivity,&#xD;
      absence of hypertension, and a more favorable lipid, inflammatory, hormonal, hepatic, and&#xD;
      immunologic profile compared to the majority of metabolically abnormal obese (MAO) patients.&#xD;
      This seeming paradox underscores that excess body the weight is not the sole determinant of&#xD;
      obesity-related complications and allows for novel pathogenic investigation.&#xD;
&#xD;
      The postulated mechanism(s) underlying the differential metabolic profile in these&#xD;
      individuals is not well known and the physiologic and molecular basis for 'healthy' obesity&#xD;
      remains relatively undiscovered. In addition, a recent meta-analysis demonstrated that&#xD;
      although MHO patients have a comparable metabolic profile to normal the weight individuals,&#xD;
      their risk of adverse, long-term CV and mortality outcomes remains higher, calling into&#xD;
      question the clinical importance of the healthy obese categorization. Despite these knowledge&#xD;
      gaps, a limited number of studies have recently attempted to elucidate the processes that&#xD;
      lead to the MHO profile, including characterization of lifestyle factors, adipocyte size,&#xD;
      amount and location of ectopic fat, inflammatory mediators, and immune cells, and differences&#xD;
      in gene expression.&#xD;
&#xD;
      The prevalence of obstructive sleep apnea (OSA) increases with increasing BMI and has also&#xD;
      been linked to various cardiometabolic abnormalities. Patients with OSA experience repetitive&#xD;
      episodes of hypoxia and reoxygenation during transient cessation of breathing that may&#xD;
      provoke adverse systemic effects. These effects are reflected in increased levels of&#xD;
      biomarkers linked to endocrine-metabolic and cardiovascular disease. OSA may exert negative&#xD;
      effects on the cardiovascular system through multiple mechanisms including hypoxemia, sleep&#xD;
      disruption, activation of the sympathetic nervous system, and inflammatory activation. In&#xD;
      spite of this connection, the contribution of these deleterious effects in determining the&#xD;
      phenotype of an obese patient (MHO vs. MAO) is unknown. Furthermore, the prevalence of OSA in&#xD;
      these two subsets is not the well established.&#xD;
&#xD;
      In this study, the investigators hypothesize the prevalence of OSA is higher in MAO compared&#xD;
      to BMI-matched MAO patients&#xD;
&#xD;
      Aim 1:&#xD;
&#xD;
      Define the prevalence of OSA in metabolically-healthy obese and metabolically abnormal obese&#xD;
      (MHO and MAO) patients.&#xD;
&#xD;
      Aim 2:&#xD;
&#xD;
      Elucidate the association of OSA disease severity parameters with markers of clinically&#xD;
      available abnormal metabolic profile (elevated cholesterol, blood pressure, fasting&#xD;
      glucose/hemoglobin A1c, inflammatory markers, and insulin resistance if available).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">January 15, 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Define the prevalence of OSA in metabolically-healthy obese and metabolically abnormal obese (MHO and MAO) patients.</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Elucidate the association of OSA disease severity parameters with markers of clinically available abnormal metabolic profile</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">850</enrollment>
  <condition>Sleep; Apnea</condition>
  <condition>Metabolism Disorder</condition>
  <arm_group>
    <arm_group_label>Metabolically healthy and abnormal obese</arm_group_label>
    <description>Obese patients divided into two groups according to their metabolic profile (healthy vs unhealthy)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include a representative sample of the patient population at OSU,&#xD;
        which is 59% Caucasian, 39% African American, and the remainder of mixed, Asian, or Native&#xD;
        American descent. The investigators will review outpatient data from subjects seen at OSU&#xD;
        Wexner Medical Center for Minimally Invasive surgery. The individual cohorts will then be&#xD;
        divided based on the presence of OSA and metabolic abnormalities.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 - 88 year old&#xD;
&#xD;
          -  BMI ≥ 30 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        ◦ Lack of pertinent clinical data to include in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>88 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Bradley</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>June 6, 2017</last_update_submitted>
  <last_update_submitted_qc>June 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>David Bradley MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Publications</ipd_description>
  </patient_data>
  <!-- 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/NCT02978937
org study id: 2015E0155
nct id: NCT02978937
lead sponsor: 
has dmc: No
This is an observational study involving chart review of patients seen in the bariatric
      clinic since 2012 at The Ohio State University (OSU). Obese patients will be divided into two
      groups according to their metabolic profile (healthy vs unhealthy). The assignment to each
      group will be determined by the presence of diagnosis of hypertension, diabetes mellitus
      and/or dyslipidemia. The presence of at least 2 diagnoses will be defined as metabolically
      unhealthy. Then, each group will be divided based on the presence of Obstructive Sleep Apnea
      diagnosis. All data will be collected through a review of the patient's electronic medical
      record from the bariatric clinic database (the investigators will collect variables as age,
      gender, race, BMI, smoking status, the presence of diagnosis as Obstructive sleep apnea,
      hypertension, diabetes, hyperlipidemia). The investigators will analyze that data and
      establish if there is any correlation between sleep apnea and the subjects' metabolic
      profile.
Obesity is associated with numerous metabolic complications including Type 2 diabetes
      mellitus, hypertension, dyslipidemia, cardiovascular disease (CVD) and several forms of
      cancer. However, the presence of these obesity-related metabolic abnormalities varies among
      obese individuals. The phenotype of a metabolically healthy obese (MHO) individual was
      initially described in 1980 and includes a subset of obese patients (as defined by BMI) who
      do not manifest the typical metabolic abnormalities associated with obesity. Although results
      are conflicting and highly dependent on patient population and diagnostic criteria for
      metabolic health, these individuals tend to have a preserved level of insulin sensitivity,
      absence of hypertension, and a more favorable lipid, inflammatory, hormonal, hepatic, and
      immunologic profile compared to the majority of metabolically abnormal obese (MAO) patients.
      This seeming paradox underscores that excess body the weight is not the sole determinant of
      obesity-related complications and allows for novel pathogenic investigation.

      The postulated mechanism(s) underlying the differential metabolic profile in these
      individuals is not well known and the physiologic and molecular basis for 'healthy' obesity
      remains relatively undiscovered. In addition, a recent meta-analysis demonstrated that
      although MHO patients have a comparable metabolic profile to normal the weight individuals,
      their risk of adverse, long-term CV and mortality outcomes remains higher, calling into
      question the clinical importance of the healthy obese categorization. Despite these knowledge
      gaps, a limited number of studies have recently attempted to elucidate the processes that
      lead to the MHO profile, including characterization of lifestyle factors, adipocyte size,
      amount and location of ectopic fat, inflammatory mediators, and immune cells, and differences
      in gene expression.

      The prevalence of obstructive sleep apnea (OSA) increases with increasing BMI and has also
      been linked to various cardiometabolic abnormalities. Patients with OSA experience repetitive
      episodes of hypoxia and reoxygenation during transient cessation of breathing that may
      provoke adverse systemic effects. These effects are reflected in increased levels of
      biomarkers linked to endocrine-metabolic and cardiovascular disease. OSA may exert negative
      effects on the cardiovascular system through multiple mechanisms including hypoxemia, sleep
      disruption, activation of the sympathetic nervous system, and inflammatory activation. In
      spite of this connection, the contribution of these deleterious effects in determining the
      phenotype of an obese patient (MHO vs. MAO) is unknown. Furthermore, the prevalence of OSA in
      these two subsets is not the well established.

      In this study, the investigators hypothesize the prevalence of OSA is higher in MAO compared
      to BMI-matched MAO patients

      Aim 1:

      Define the prevalence of OSA in metabolically-healthy obese and metabolically abnormal obese
      (MHO and MAO) patients.

      Aim 2:

      Elucidate the association of OSA disease severity parameters with markers of clinically
      available abnormal metabolic profile (elevated cholesterol, blood pressure, fasting
      glucose/hemoglobin A1c, inflammatory markers, and insulin resistance if available).
observational model: Cohort
time perspective: Retrospective
measure: Define the prevalence of OSA in metabolically-healthy obese and metabolically abnormal obese (MHO and MAO) patients.
time frame: 2 years
measure: Elucidate the association of OSA disease severity parameters with markers of clinically available abnormal metabolic profile
time frame: 2 years
arm group label: Metabolically healthy and abnormal obese
description: Obese patients divided into two groups according to their metabolic profile (healthy vs unhealthy)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 88 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Bradley
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: David Bradley MD
investigator title: MD
mesh term: Apnea
mesh term: Metabolic Diseases
sharing ipd: No
ipd description: Publications