<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/NCT02206126</url>
  </required_header>
  <id_info>
    <org_study_id>CLINEX05</org_study_id>
    <nct_id>NCT02206126</nct_id>
  </id_info>
  <brief_title>Weight Loss and Obstructive Sleep Apnea</brief_title>
  <official_title>Effects of Energy Restriction on Sleep Apnea, Sympathetic Activity, Oxidative Stress, Inflammatory Biomarkers, Endothelial Function, Body Adiposity, Metabolic Profile and Blood Pressure in Obese Patients With Obstructive Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rio de Janeiro State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rio de Janeiro State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effects of moderate energy restriction on the&#xD;
      body adiposity, severity of OSA, blood pressure, sympathetic activity, oxidative stress,&#xD;
      inflammatory biomarkers, metabolic profile and endothelial function in obese patients with&#xD;
      OSA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Nutritional intervention for weight loss is one of the treatment options for&#xD;
      obstructive sleep apnea (OSA) in patients with excess body adiposity. However, the effects of&#xD;
      moderate energy restriction, recommended by current guidelines for the treatment of obesity,&#xD;
      on OSA are not yet known. Objective: To evaluate the effects of moderate energy restriction&#xD;
      on the body adiposity; severity of OSA; blood pressure; sympathetic activity; oxidative&#xD;
      stress; inflammatory biomarkers; metabolic profile and endothelial function in obese patients&#xD;
      with OSA. Methods: A 16-week randomized clinical trial, involving 21 subjects with obesity&#xD;
      (grade I or II), aged 20-55 years and presenting an apnea/hipopnea index (AHI) &gt; 5 events/h.&#xD;
      Participants were randomized into 2 groups: 11 in the energy restriction group (ERG) and 10&#xD;
      in the control group (CG). The ERG was instructed to follow an energy-restricted diet (-800&#xD;
      kcal/day) and the CG was advised not to change their food intake. At the beginning and at the&#xD;
      end of the study, participants underwent evaluation of: OSA with the equipment Watch- PAT200®&#xD;
      including the determination of the following parameters of OSA severity: AHI, minimum O2&#xD;
      saturation, number of O2 desaturations &gt;4%; body adiposity (weight, %body fat and&#xD;
      circumferences of waist, hip and neck); blood pressure (BP); sympathetic nervous system&#xD;
      activity (plasma levels of catecholamines); inflammatory biomarkers (c-reactive protein and&#xD;
      adiponectin); oxidative stress (malondialdehyde); metabolism of glucose (glucose, insulin and&#xD;
      HOMA-IR) and lipids (total cholesterol and fractions and triglycerides); and endothelial&#xD;
      function (index of reactive hyperemia evaluated by Endo - PAT 2000® and cellular adhesion&#xD;
      molecules). The statistical analysis was performed with the software STATA v. 10. The level&#xD;
      of statistical significance was p &lt; 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea/hipopnea index</measure>
    <time_frame>16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sympathetic activity</measure>
    <time_frame>16 weeks</time_frame>
    <description>Plasma levels of catecholamines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress</measure>
    <time_frame>16 weeks</time_frame>
    <description>Serum levels of malondialdehyde</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory biomarkers</measure>
    <time_frame>16 weeks</time_frame>
    <description>Circulating levels of high-sensitivity C reactive protein and adiponectin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic profile</measure>
    <time_frame>16 weeks</time_frame>
    <description>Fasting plasma glucose, insulin, total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial function</measure>
    <time_frame>16 weeks</time_frame>
    <description>Circulating levels of cellular adhesion molecules (intercellular adhesion molecule 1 and P-selectin).&#xD;
Endothelial function was also evaluated by the PAT method, using Endo-PAT 2000®.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Energy restriction group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group was advised not to change their food intake.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Energy Restriction</intervention_name>
    <description>The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day).</description>
    <arm_group_label>Energy restriction group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 20-55 years&#xD;
&#xD;
          -  body mass index (BMI) ≥ 30 kg/m2 and &lt; 40 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  Use of dietary supplements&#xD;
&#xD;
          -  Use of medications that could interfere in body weight, metabolic profile and blood&#xD;
             pressure&#xD;
&#xD;
          -  Use of permanent pacemaker; use of α-adrenergic blocking agents&#xD;
&#xD;
          -  Recent changes (within previous 6 months) in body weight (&gt; 3 kg), in dietary intake&#xD;
             and in intensity or frequency of physical exercise&#xD;
&#xD;
          -  Diagnosis of diabetes mellitus, hypertension, dyslipidemia (with drug treatment) and&#xD;
             kidney disease&#xD;
&#xD;
          -  Clinical history of thyroid dysfunction, angina pectoris, peripheral vascular disease,&#xD;
             peripheral neuropathy, heart failure, liver failure, chronic pulmonary disease,&#xD;
             gastroesophageal reflux disease, myocardial infarction and stroke; finger deformity&#xD;
             that prevents the proper use of the sensors that are necessary to evaluate OSA and&#xD;
             endothelial function; and previous bilateral cervical-thoracic sympathectomy&#xD;
&#xD;
          -  Pregnant or lactating women were not allowed into the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Felipe Sanjuliani, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rio de Janeiro State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Discipline of Clinical and Experimental Pathophysiology, CLINEX</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20.551-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 30, 2014</last_update_submitted>
  <last_update_submitted_qc>July 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rio de Janeiro State University</investigator_affiliation>
    <investigator_full_name>Antonio Felipe Sanjuliani</investigator_full_name>
    <investigator_title>Antonio Felipe Sanjuliani</investigator_title>
  </responsible_party>
  <keyword>Obstructive sleep apnea</keyword>
  <keyword>Weight loss</keyword>
  <keyword>Obesity</keyword>
  <keyword>Sympathetic activity</keyword>
  <keyword>Metabolic profile</keyword>
  <keyword>Endothelial function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</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/NCT02206126
org study id: CLINEX05
nct id: NCT02206126
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effects of moderate energy restriction on the
      body adiposity, severity of OSA, blood pressure, sympathetic activity, oxidative stress,
      inflammatory biomarkers, metabolic profile and endothelial function in obese patients with
      OSA.
Introduction: Nutritional intervention for weight loss is one of the treatment options for
      obstructive sleep apnea (OSA) in patients with excess body adiposity. However, the effects of
      moderate energy restriction, recommended by current guidelines for the treatment of obesity,
      on OSA are not yet known. Objective: To evaluate the effects of moderate energy restriction
      on the body adiposity; severity of OSA; blood pressure; sympathetic activity; oxidative
      stress; inflammatory biomarkers; metabolic profile and endothelial function in obese patients
      with OSA. Methods: A 16-week randomized clinical trial, involving 21 subjects with obesity
      (grade I or II), aged 20-55 years and presenting an apnea/hipopnea index (AHI) > 5 events/h.
      Participants were randomized into 2 groups: 11 in the energy restriction group (ERG) and 10
      in the control group (CG). The ERG was instructed to follow an energy-restricted diet (-800
      kcal/day) and the CG was advised not to change their food intake. At the beginning and at the
      end of the study, participants underwent evaluation of: OSA with the equipment Watch- PAT200®
      including the determination of the following parameters of OSA severity: AHI, minimum O2
      saturation, number of O2 desaturations >4%; body adiposity (weight, %body fat and
      circumferences of waist, hip and neck); blood pressure (BP); sympathetic nervous system
      activity (plasma levels of catecholamines); inflammatory biomarkers (c-reactive protein and
      adiponectin); oxidative stress (malondialdehyde); metabolism of glucose (glucose, insulin and
      HOMA-IR) and lipids (total cholesterol and fractions and triglycerides); and endothelial
      function (index of reactive hyperemia evaluated by Endo - PAT 2000® and cellular adhesion
      molecules). The statistical analysis was performed with the software STATA v. 10. The level
      of statistical significance was p < 0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Apnea/hipopnea index
time frame: 16 weeks
measure: Blood pressure
time frame: 16 weeks
measure: Sympathetic activity
time frame: 16 weeks
description: Plasma levels of catecholamines
measure: Oxidative stress
time frame: 16 weeks
description: Serum levels of malondialdehyde
measure: Inflammatory biomarkers
time frame: 16 weeks
description: Circulating levels of high-sensitivity C reactive protein and adiponectin
measure: Metabolic profile
time frame: 16 weeks
description: Fasting plasma glucose, insulin, total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides
measure: Endothelial function
time frame: 16 weeks
description: Circulating levels of cellular adhesion molecules (intercellular adhesion molecule 1 and P-selectin).
Endothelial function was also evaluated by the PAT method, using Endo-PAT 2000®.
arm group label: Energy restriction group
arm group type: Experimental
description: The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day).
arm group label: Control group
arm group type: No Intervention
description: The control group was advised not to change their food intake.
intervention type: Behavioral
intervention name: Energy Restriction
description: The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day).
arm group label: Energy restriction group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Antonio Felipe Sanjuliani, Dr.
role: Principal Investigator
affiliation: Rio de Janeiro State University
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Rio de Janeiro State University
investigator full name: Antonio Felipe Sanjuliani
investigator title: Antonio Felipe Sanjuliani
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive