<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/NCT01692327</url>
  </required_header>
  <id_info>
    <org_study_id>Biovasc-02</org_study_id>
    <secondary_id>Biovasc002</secondary_id>
    <nct_id>NCT01692327</nct_id>
  </id_info>
  <brief_title>Study About High Fat Meal and Postprandial Lipemia</brief_title>
  <official_title>Evaluating the Effect of Lipid Overload in Endothelial Function and Microvascular Reactivity in Young Obese Women</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The hypothesis of the proposed project is that after a fat overload, the postprandial&#xD;
      response is different in both groups, suggesting that the LPP will present the most&#xD;
      significant damage in endothelial vasomotion in obese individuals, especially those with GI&#xD;
      and T2DM. After the fat overload, we hypothesized that there will be a worsening of&#xD;
      endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but&#xD;
      also find lower concentrations of incretins in OB/DM2 group compared to other groups.&#xD;
&#xD;
      These hypotheses may be confirmed by techniques for evaluating microvascular function, the&#xD;
      use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic&#xD;
      and cardiovascular read by Multiplex kit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Will be recruited 60 women aged 19-40 years, with a diagnosis of obesity (BMI ≥ 30 kg/m2)&#xD;
      treated at the obesity clinic at the State University of Rio de Janeiro (UERJ)at Brazil.&#xD;
&#xD;
      Microcirculation parameters and blood tests will be assessed at baseline and after this, the&#xD;
      women will receive a high-fat meal containing croissant, salami, whole milk and cheddar&#xD;
      cheese. After 30, 60, 120 and 180 minutes this meal the microcirculation will be evaluated as&#xD;
      well as blood collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Microvascular function</measure>
    <time_frame>up to 180 minutes after high fat meal</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>incretins hormones</measure>
    <time_frame>basal, 30, 60, 120,180 minutes after high fat meal</time_frame>
    <description>We will assess incretins hormones by multiplex</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Obese Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Obese group with fat overload intake.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control Group + fat overload intake</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glucose Intolerance</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>glucose intolerance + fat overload intake</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High fat meal</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Glucose Intolerance</arm_group_label>
    <arm_group_label>Obese Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients should have obesity class I (BMI between 30 and 35kg/m2);&#xD;
&#xD;
          -  Submit diabetes mellitus without further treatment or be obese non-diabetic or glucose&#xD;
             intolerant;&#xD;
&#xD;
          -  Presenting the age between 19 to 40 years.&#xD;
&#xD;
          -  Waist circumference&gt; 80 cm (IDF)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Renal disease, coronary or peripheral vascular, hematologic or hepatic impairment;&#xD;
&#xD;
          -  Presence of dyslipidemia;&#xD;
&#xD;
          -  smokers;&#xD;
&#xD;
          -  Significant loss of body weight six months prior to the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rio de Janeiro State University</name>
      <address>
        <city>Rio de janeiro</city>
        <zip>20550900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>November 4, 2014</last_update_submitted>
  <last_update_submitted_qc>November 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 5, 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>Priscila Alves Maranhao</investigator_full_name>
    <investigator_title>Nutricionist</investigator_title>
  </responsible_party>
  <keyword>glucose intolerance (20)</keyword>
  <keyword>Control (20)</keyword>
  <!-- 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/NCT01692327
org study id: Biovasc-02
secondary id: Biovasc002
nct id: NCT01692327
lead sponsor: 
has dmc: Yes
The hypothesis of the proposed project is that after a fat overload, the postprandial
      response is different in both groups, suggesting that the LPP will present the most
      significant damage in endothelial vasomotion in obese individuals, especially those with GI
      and T2DM. After the fat overload, we hypothesized that there will be a worsening of
      endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but
      also find lower concentrations of incretins in OB/DM2 group compared to other groups.

      These hypotheses may be confirmed by techniques for evaluating microvascular function, the
      use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic
      and cardiovascular read by Multiplex kit.
Will be recruited 60 women aged 19-40 years, with a diagnosis of obesity (BMI ≥ 30 kg/m2)
      treated at the obesity clinic at the State University of Rio de Janeiro (UERJ)at Brazil.

      Microcirculation parameters and blood tests will be assessed at baseline and after this, the
      women will receive a high-fat meal containing croissant, salami, whole milk and cheddar
      cheese. After 30, 60, 120 and 180 minutes this meal the microcirculation will be evaluated as
      well as blood collection.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Microvascular function
time frame: up to 180 minutes after high fat meal
measure: incretins hormones
time frame: basal, 30, 60, 120,180 minutes after high fat meal
description: We will assess incretins hormones by multiplex
arm group label: Obese Group
arm group type: Other
description: Obese group with fat overload intake.
arm group label: Control Group
arm group type: Other
description: Control Group + fat overload intake
arm group label: Glucose Intolerance
arm group type: Other
description: glucose intolerance + fat overload intake
intervention type: Dietary Supplement
intervention name: High fat meal
arm group label: Control Group
arm group label: Glucose Intolerance
arm group label: Obese Group
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Rio de Janeiro State University
investigator full name: Priscila Alves Maranhao
investigator title: Nutricionist