<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/NCT02226536</url>
  </required_header>
  <id_info>
    <org_study_id>DMG-PDCEAV</org_study_id>
    <nct_id>NCT02226536</nct_id>
  </id_info>
  <brief_title>Vestibular Dysfunction and Glucose Metabolism</brief_title>
  <official_title>Fractionated and Restrictive Glucose Diet in Patients With Vestibular Dysfunction: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: the global sugar consumption has increased in the past 50 years and their&#xD;
      abusive intake is responsible for the insulin resistance and causes the metabolic syndrome -&#xD;
      obesity, diabetes mellitus, hypertension and coronary heart disease. Objective: To evaluate&#xD;
      the effect of scheduled diet without glucose as treatment of labyrinthine disorders&#xD;
      associated with glucose-insulin index. Study Design: A prospective randomized controlled&#xD;
      trial. Patients and Methods: A study conducted at the University of São Paulo with 51&#xD;
      patients divided into two groups: Diet Group (DG) that comprises subjects treated with&#xD;
      fractionated diet with glucose restriction and control group (CG) where individuals were not&#xD;
      counseled regarding diet. Patients underwent computerized dynamic posturography - sensory&#xD;
      organization test (CDP - SOT) and Visual Analog Scale (VAS) in the first and thirtieth days&#xD;
      of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      51 patientes with dizziness and glucose intolerance diagnosed by the glucose tolerance test&#xD;
      were selected.&#xD;
&#xD;
      The subjects were submited to CDP SOT conditions and a visual analogue scale to measure his&#xD;
      self perception about dizziness.&#xD;
&#xD;
      Then, they were randomized in two groups: with and without fractioned diet without glucose&#xD;
      during 30 days.&#xD;
&#xD;
      The CDP was repeated in order to verify a statistical difference of SOT condition 5 that&#xD;
      reflects the individual hability to maintain the own posture with the vestibule solely and CS&#xD;
      - that represents the final balance situation.&#xD;
&#xD;
      The VAS was repeated too in order to verify the self perception of the dizziness after diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2005</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2010</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self perception of dizziness mesured by the visual analogue scale</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Dysfunction of Vestibular System</condition>
  <condition>Glucose Intolerance</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Usual diet without any orientation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fractioned diet without glucose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fractioned diet without glucose</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>fractioned diet without glucose</intervention_name>
    <description>Patients were divided into two groups: Diet Group was treated with placebo pills and glucose restrictive and fractionated diet. Control Group received only placebo pills. All individuals had their vestibular function evaluated by Computerized Dynamic Posturography and done visual analogue scale (VAS) in the first day and 30 days after diet intervention</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>fractioned diet without glucose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  dizziness related to fasting or glucose intake&#xD;
&#xD;
          -  alterations of glucose tolerance test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dizziness not related to vestibular problems&#xD;
&#xD;
          -  ortopedical or neurological diseases&#xD;
&#xD;
          -  diabetes mellitus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roseli SM Bittar, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo, Brazil</affiliation>
  </overall_official>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>June 9, 2022</last_update_submitted>
  <last_update_submitted_qc>June 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Roseli Saraiva Moreira Bittar</investigator_full_name>
    <investigator_title>Assistente Doutor da Faculdade de Medicina da Universidade de São Paulo</investigator_title>
  </responsible_party>
  <keyword>Posture</keyword>
  <keyword>Vertigo</keyword>
  <keyword>glucose metabolism</keyword>
  <keyword>diet</keyword>
  <keyword>scales</keyword>
  <keyword>dinamic posturography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucose Intolerance</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/NCT02226536
org study id: DMG-PDCEAV
nct id: NCT02226536
lead sponsor: 
has dmc: Yes
Introduction: the global sugar consumption has increased in the past 50 years and their
      abusive intake is responsible for the insulin resistance and causes the metabolic syndrome -
      obesity, diabetes mellitus, hypertension and coronary heart disease. Objective: To evaluate
      the effect of scheduled diet without glucose as treatment of labyrinthine disorders
      associated with glucose-insulin index. Study Design: A prospective randomized controlled
      trial. Patients and Methods: A study conducted at the University of São Paulo with 51
      patients divided into two groups: Diet Group (DG) that comprises subjects treated with
      fractionated diet with glucose restriction and control group (CG) where individuals were not
      counseled regarding diet. Patients underwent computerized dynamic posturography - sensory
      organization test (CDP - SOT) and Visual Analog Scale (VAS) in the first and thirtieth days
      of the study.
51 patientes with dizziness and glucose intolerance diagnosed by the glucose tolerance test
      were selected.

      The subjects were submited to CDP SOT conditions and a visual analogue scale to measure his
      self perception about dizziness.

      Then, they were randomized in two groups: with and without fractioned diet without glucose
      during 30 days.

      The CDP was repeated in order to verify a statistical difference of SOT condition 5 that
      reflects the individual hability to maintain the own posture with the vestibule solely and CS
      - that represents the final balance situation.

      The VAS was repeated too in order to verify the self perception of the dizziness after diet.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients
time frame: 30 days
measure: Self perception of dizziness mesured by the visual analogue scale
time frame: 30 days
arm group label: control
arm group type: Placebo Comparator
description: Usual diet without any orientation
arm group label: fractioned diet without glucose
arm group type: Active Comparator
description: Fractioned diet without glucose
intervention type: Behavioral
intervention name: fractioned diet without glucose
description: Patients were divided into two groups: Diet Group was treated with placebo pills and glucose restrictive and fractionated diet. Control Group received only placebo pills. All individuals had their vestibular function evaluated by Computerized Dynamic Posturography and done visual analogue scale (VAS) in the first day and 30 days after diet intervention
arm group label: control
arm group label: fractioned diet without glucose
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roseli SM Bittar, MD, PhD
role: Principal Investigator
affiliation: University of São Paulo, Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Roseli Saraiva Moreira Bittar
investigator title: Assistente Doutor da Faculdade de Medicina da Universidade de São Paulo
mesh term: Glucose Intolerance