<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/NCT01729078</url>
  </required_header>
  <id_info>
    <org_study_id>12-003216</org_study_id>
    <nct_id>NCT01729078</nct_id>
  </id_info>
  <brief_title>Dietary Interventions in Prediabetes</brief_title>
  <official_title>The Effects of Dietary Supplementation on Hepatic Insulin Action and Glucose Tolerance in Pre-diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <brief_summary>
    <textblock>
      Assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre&#xD;
      diabetes subjects. Subjects will be randomized to either high fat (olive oil&#xD;
      supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets.&#xD;
      Glucose metabolism will be assessed by labeled oral glucose tolerance test and liver fat by&#xD;
      magnetic resonance spectroscopy pre randomization and at 8 and 12 week after starting dietary&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2014</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>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in liver fat content after 12 weeks of intervention</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in glucose metabolism after 12 weeks of intervention</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Impaired Fasting Glucose</condition>
  <condition>Pre Diabetes</condition>
  <condition>Liver Fat</condition>
  <arm_group>
    <arm_group_label>high fat ( MUFA) diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention using high fat diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high carb/high fiber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>diet using high carb-high fiber with dry beans</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high carb/low fat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Habitual diet</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Dietary intervention</intervention_name>
    <description>three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)</description>
    <arm_group_label>high carb/high fiber</arm_group_label>
    <arm_group_label>high carb/low fat</arm_group_label>
    <arm_group_label>high fat ( MUFA) diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Impaired fasting glucose(100-125 mg/dl)&#xD;
&#xD;
          -  HbA1c 5.7-6.4 %&#xD;
&#xD;
          -  BMI 26-40 kg/sq.m&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  MRS contraindication&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Liver disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mayo clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>July 27, 2015</last_update_submitted>
  <last_update_submitted_qc>July 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Rita Basu</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
    <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/NCT01729078
org study id: 12-003216
nct id: NCT01729078
lead sponsor: 
Assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre
      diabetes subjects. Subjects will be randomized to either high fat (olive oil
      supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets.
      Glucose metabolism will be assessed by labeled oral glucose tolerance test and liver fat by
      magnetic resonance spectroscopy pre randomization and at 8 and 12 week after starting dietary
      intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
measure: Changes in liver fat content after 12 weeks of intervention
time frame: 12 weeks
measure: Change in glucose metabolism after 12 weeks of intervention
time frame: 12 weeks
arm group label: high fat ( MUFA) diet
arm group type: Experimental
description: intervention using high fat diet.
arm group label: high carb/high fiber
arm group type: Experimental
description: diet using high carb-high fiber with dry beans
arm group label: high carb/low fat
arm group type: Experimental
description: Habitual diet
intervention type: Dietary Supplement
intervention name: Dietary intervention
description: three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)
arm group label: high carb/high fiber
arm group label: high carb/low fat
arm group label: high fat ( MUFA) diet
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Rita Basu
investigator title: PI
mesh term: Prediabetic State
mesh term: Glucose Intolerance