<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/NCT03261362</url>
  </required_header>
  <id_info>
    <org_study_id>2014092783</org_study_id>
    <nct_id>NCT03261362</nct_id>
  </id_info>
  <brief_title>Impact of Branched-chain Amino Acids in the Development of Insulin Resistance</brief_title>
  <acronym>BRAAWO</acronym>
  <official_title>Branched-Chain Amino Acid Dietary Reduction Under Weight Maintainance in Overweight Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>German Diabetes Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>German Diabetes Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to clarify the role of the branched-chain amino acids in the&#xD;
      development of Insulin resistance in patients with diabetes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed project aims to elucidate the role of the BCAA in the development of insulin&#xD;
      resistance and type 2 diabetes. The project tests the hypothesis that a diet induced decrease&#xD;
      of BCAAs concentrations alter the metabolic mechanisms involved in the control insulin&#xD;
      resistance and diabetes progression.&#xD;
&#xD;
      The specific aims are to elucidate the effect of the diet induced decrease of BCAAs&#xD;
      concentrations on (I) peripheral and hepatic insulin sensitivity (II) ectopic fat&#xD;
      distribution (III) energy metabolism (IV) metabolic and inflammatory status&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clamp test</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Insulin sensitivity test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mixed Meal Test</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>B cell function test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Amino acid powder with all amino acids</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>amino acid powder 80 g oral Administration 1 week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amino acid powder without BCAAs-reduced intake</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Branched-chain amino acids reduced intake - amino acid powder lacking BCAAs 80 g oral Administration 1 week -</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Branched-chain amino acids reduced intake</intervention_name>
    <arm_group_label>Amino acid powder with all amino acids</arm_group_label>
    <arm_group_label>Amino acid powder without BCAAs-reduced intake</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetes type 2&#xD;
&#xD;
          -  Non smokers&#xD;
&#xD;
          -  Untrained&#xD;
&#xD;
          -  Willingness to adhere to a diet intervention&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic disease&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Cancer&#xD;
&#xD;
          -  Antibiotic therapy&#xD;
&#xD;
          -  Drug/alcohol abuse&#xD;
&#xD;
          -  Competitive athletes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Roden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Deutsches Diabetes Zentrum</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>German Diabetes Centre</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <pending_results>
    <submitted>June 12, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03261362
org study id: 2014092783
nct id: NCT03261362
lead sponsor: 
The purpose of this study is to clarify the role of the branched-chain amino acids in the
      development of Insulin resistance in patients with diabetes
The proposed project aims to elucidate the role of the BCAA in the development of insulin
      resistance and type 2 diabetes. The project tests the hypothesis that a diet induced decrease
      of BCAAs concentrations alter the metabolic mechanisms involved in the control insulin
      resistance and diabetes progression.

      The specific aims are to elucidate the effect of the diet induced decrease of BCAAs
      concentrations on (I) peripheral and hepatic insulin sensitivity (II) ectopic fat
      distribution (III) energy metabolism (IV) metabolic and inflammatory status
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Clamp test
time frame: up to 24 weeks
description: Insulin sensitivity test
measure: Mixed Meal Test
time frame: up to 24 weeks
description: B cell function test
arm group label: Amino acid powder with all amino acids
arm group type: Placebo Comparator
description: amino acid powder 80 g oral Administration 1 week
arm group label: Amino acid powder without BCAAs-reduced intake
arm group type: Active Comparator
description: Branched-chain amino acids reduced intake - amino acid powder lacking BCAAs 80 g oral Administration 1 week -
intervention type: Dietary Supplement
intervention name: Branched-chain amino acids reduced intake
arm group label: Amino acid powder with all amino acids
arm group label: Amino acid powder without BCAAs-reduced intake
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: No
last name: Michael Roden, MD
role: Principal Investigator
affiliation: Deutsches Diabetes Zentrum
facility: 
country: Germany
responsible party type: Sponsor
submitted: June 12, 2023