<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/NCT02235194</url>
  </required_header>
  <id_info>
    <org_study_id>SWZRP-14-01</org_study_id>
    <nct_id>NCT02235194</nct_id>
  </id_info>
  <brief_title>Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism</brief_title>
  <official_title>Influence of an Amino Acid and Chromium Containing Table Water on Glucose Response to a Test Meal in Type 2 Diabetes Patients in a Double Blind Cross - Over Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stoffwechselzentrum Rhein - Pfalz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stoffwechselzentrum Rhein - Pfalz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has previously been shown in healthy overweight subjects, that table water including a&#xD;
      defined amount of amino acids and chromium can decrease the postprandial glucose and insulin&#xD;
      response. In this study, the effect of this table water on glucose excursions after a test&#xD;
      meal containing a defined amount of available carbohydrates, protein and fat will be studied&#xD;
      in patients with early type 2 diabetes or prediabetes according to guidelines that are&#xD;
      treated with dietary measures or metformin only. The study will be conducted in a cross -over&#xD;
      design, double blinded and placebo controlled including 20 participants. The primary endpoint&#xD;
      of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180&#xD;
      minutes after ingestion of the meal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the curve for Glucose</measure>
    <time_frame>0', 15', 30', 60', 90', 120', 150', 180' post test meal</time_frame>
    <description>Area under the curve for glucose will be measured within 180 minutes after a test meal. Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180').</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC for insulin</measure>
    <time_frame>0', 15', 30', 60', 90', 120', 150', 180' post test meal</time_frame>
    <description>Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180').</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of inflammation</measure>
    <time_frame>at 0', 15', 30', 60', 90', 120', 150', 180' post test meal</time_frame>
    <description>Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180'). At these timepoints markers of inflammation will be measured (i.e. hsCRP and others)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>markers of lipid metabolism</measure>
    <time_frame>0', 15', 30', 60', 90', 120', 150', 180' post test meal</time_frame>
    <description>Triglycerides, VLDL and other parameters of lipid metabolism are planned to be measured within 180 minutes after a test meal at 0', 15', 30', 60', 90', 120', 150', 180'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gut peptide hormones</measure>
    <time_frame>0', 15', 30', 60', 90', 120', 150', 180' post test meal</time_frame>
    <description>Area under the curve for GLP-1, ghrelin, glucagone and GIP are measured within 180 minutes after the test meal.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Prediabetes</condition>
  <arm_group>
    <arm_group_label>Amino Acids, Chromium - Picolinate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Verum drink containing the dietary supplements is taken with a test meal. INsulin and glucose response is documented for 180 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Drink</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Drink containing aroma only is taken with a test meal. INsulin and glucose response is documented for 180 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Amino Acid and chromium-picolinate containing drink</intervention_name>
    <description>Amino Acid and chromium - picolinate containg water ist taken with a test meal to study efects on glucose and insulin response.</description>
    <arm_group_label>Amino Acids, Chromium - Picolinate</arm_group_label>
    <arm_group_label>Placebo Drink</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo Drink</intervention_name>
    <description>Placebo drink ist taken with a test meal to study efects on glucose and insulin response.</description>
    <arm_group_label>Amino Acids, Chromium - Picolinate</arm_group_label>
    <arm_group_label>Placebo Drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Early Type 2 Diabetes (i.e. on Metformin or diet only)&#xD;
&#xD;
          -  Prediabetes (i.e. FPG 100-125 mg/dl or IGT 2h PG in OGTT 140-199 mg/dl)&#xD;
&#xD;
          -  HbA1c &lt; 7%&#xD;
&#xD;
          -  BMI 28,0-39,9 kg/m²&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Any antidiabetic medication other than metformin&#xD;
&#xD;
          -  Psychiatric Disease&#xD;
&#xD;
          -  Acute Infections&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
&#xD;
          -  Malignant tumors or hematologic disorders&#xD;
&#xD;
          -  Heart failure NYHA III-IV&#xD;
&#xD;
          -  Acute coronary syndrome&#xD;
&#xD;
          -  Any macrovascular event within previous 3 months&#xD;
&#xD;
          -  Chronic kidney disease &gt; Stage 3&#xD;
&#xD;
          -  Pregnancy or Lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Stoffwechselzentrum Rhein Pfalz</name>
      <address>
        <city>Mannheim</city>
        <zip>68163</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>September 20, 2019</last_update_submitted>
  <last_update_submitted_qc>September 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stoffwechselzentrum Rhein - Pfalz</investigator_affiliation>
    <investigator_full_name>Dr. Per Humpert</investigator_full_name>
    <investigator_title>Privatdozent Dr. Per M. Humpert</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chromium</mesh_term>
    <mesh_term>Picolinic acid</mesh_term>
  </intervention_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/NCT02235194
org study id: SWZRP-14-01
nct id: NCT02235194
lead sponsor: 
has dmc: No
It has previously been shown in healthy overweight subjects, that table water including a
      defined amount of amino acids and chromium can decrease the postprandial glucose and insulin
      response. In this study, the effect of this table water on glucose excursions after a test
      meal containing a defined amount of available carbohydrates, protein and fat will be studied
      in patients with early type 2 diabetes or prediabetes according to guidelines that are
      treated with dietary measures or metformin only. The study will be conducted in a cross -over
      design, double blinded and placebo controlled including 20 participants. The primary endpoint
      of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180
      minutes after ingestion of the meal.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Area under the curve for Glucose
time frame: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
description: Area under the curve for glucose will be measured within 180 minutes after a test meal. Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180').
measure: AUC for insulin
time frame: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
description: Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180').
measure: Markers of inflammation
time frame: at 0', 15', 30', 60', 90', 120', 150', 180' post test meal
description: Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180'). At these timepoints markers of inflammation will be measured (i.e. hsCRP and others)
measure: markers of lipid metabolism
time frame: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
description: Triglycerides, VLDL and other parameters of lipid metabolism are planned to be measured within 180 minutes after a test meal at 0', 15', 30', 60', 90', 120', 150', 180'.
measure: Gut peptide hormones
time frame: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
description: Area under the curve for GLP-1, ghrelin, glucagone and GIP are measured within 180 minutes after the test meal.
arm group label: Amino Acids, Chromium - Picolinate
arm group type: Active Comparator
description: Verum drink containing the dietary supplements is taken with a test meal. INsulin and glucose response is documented for 180 minutes.
arm group label: Placebo Drink
arm group type: Placebo Comparator
description: Placebo Drink containing aroma only is taken with a test meal. INsulin and glucose response is documented for 180 minutes.
intervention type: Dietary Supplement
intervention name: Amino Acid and chromium-picolinate containing drink
description: Amino Acid and chromium - picolinate containg water ist taken with a test meal to study efects on glucose and insulin response.
arm group label: Amino Acids, Chromium - Picolinate
arm group label: Placebo Drink
intervention type: Dietary Supplement
intervention name: Placebo Drink
description: Placebo drink ist taken with a test meal to study efects on glucose and insulin response.
arm group label: Amino Acids, Chromium - Picolinate
arm group label: Placebo Drink
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Stoffwechselzentrum Rhein - Pfalz
investigator full name: Dr. Per Humpert
investigator title: Privatdozent Dr. Per M. Humpert
mesh term: Diabetes Mellitus, Type 2
mesh term: Chromium
mesh term: Picolinic acid