<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/NCT01678742</url>
  </required_header>
  <id_info>
    <org_study_id>2012-06-007-002</org_study_id>
    <secondary_id>C0038345</secondary_id>
    <nct_id>NCT01678742</nct_id>
  </id_info>
  <brief_title>Effects of Jeju Red Horsehead Fish-based, High Protein Diet on Satiety and Incretin Hormones in Diabetes Patients</brief_title>
  <official_title>Effects of Jeju Red Horsehead Fish-based, High Protein Diet on Satiety and Incretin Hormones in Diabetes Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jeju National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jeju National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study is to investigate the effects of high-protein diet on satiety and&#xD;
      incretin hormones in patients with diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in the incremental area under the curve (iAUC) for peptide YY (PYY) after food ingestion between high-protein and standard diet groups</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in the iAUC for cholecystokinin (CCK) after food ingestion between high-protein and standard diet groups</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the iAUC for ghrelin after food ingestion between high-protein and standard diet groups</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the iAUC for glucagon-like peptide 1 (GLP-1) after food ingestion between high-protein and standard diet groups</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the iAUC for glucose-dependent insulinotropic polypeptide (GIP) after food ingestion between high-protein and standard diet groups</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Difference in the iAUC for glucose after food ingestion between high-protein and standard diet groups</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.</description>
  </other_outcome>
  <other_outcome>
    <measure>Difference in the iAUC for insulin after food ingestion between high-protein and standard diet groups</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.</description>
  </other_outcome>
  <other_outcome>
    <measure>Difference in the iAUC for C-peptide after food ingestion between high-protein and standard diet groups</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.</description>
  </other_outcome>
  <other_outcome>
    <measure>Difference in the iAUC for glucagon after food ingestion between high-protein and standard diet groups</measure>
    <time_frame>3 hours</time_frame>
    <description>Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>High-protein diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>High-protein diet</intervention_name>
    <description>The high-protein diet is made up of 50% carbohydrate, 40% of protein and 10% of fat, providing 480 kcal.&#xD;
A protein part of the high-protein diet is mostly composed of a grilled Jeju red horsehead fish, a special product of Jeju island in Korea.</description>
    <arm_group_label>High-protein diet</arm_group_label>
    <other_name>A Jeju red horsehead fish-based meal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Standard diet</intervention_name>
    <description>The standard diet is made up of 60% carbohydrate, 20% of protein and 20% of fat, providing 480 kcal.</description>
    <arm_group_label>Standard diet</arm_group_label>
    <other_name>A mixed meal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Subjects signed a written informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Liver cirrhosis&#xD;
&#xD;
          -  Chronic renal disease (serum creatinine &gt; 2mg/dL)&#xD;
&#xD;
          -  Severe congestive heart failure&#xD;
&#xD;
          -  Significant infectious or inflammatory diseases&#xD;
&#xD;
          -  intractable malignant neoplasm&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gwanpyo Koh, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jeju National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jeju National University Hospital</name>
      <address>
        <city>Jeju</city>
        <zip>690-767</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 25, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>March 31, 2015</last_update_submitted>
  <last_update_submitted_qc>March 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jeju National University Hospital</investigator_affiliation>
    <investigator_full_name>Gwanpyo Koh</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Diet</keyword>
  <keyword>Incretins</keyword>
  <keyword>Gastrointestinal Hormones</keyword>
  <keyword>Fish Proteins</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT01678742
org study id: 2012-06-007-002
secondary id: C0038345
nct id: NCT01678742
lead sponsor: 
has dmc: No
The aim of our study is to investigate the effects of high-protein diet on satiety and
      incretin hormones in patients with diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difference in the incremental area under the curve (iAUC) for peptide YY (PYY) after food ingestion between high-protein and standard diet groups
time frame: 3 hours
description: Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
measure: Difference in the iAUC for cholecystokinin (CCK) after food ingestion between high-protein and standard diet groups
time frame: 3 hours
description: Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
measure: Difference in the iAUC for ghrelin after food ingestion between high-protein and standard diet groups
time frame: 3 hours
description: Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
measure: Difference in the iAUC for glucagon-like peptide 1 (GLP-1) after food ingestion between high-protein and standard diet groups
time frame: 3 hours
description: Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
measure: Difference in the iAUC for glucose-dependent insulinotropic polypeptide (GIP) after food ingestion between high-protein and standard diet groups
time frame: 3 hours
description: Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
measure: Difference in the iAUC for glucose after food ingestion between high-protein and standard diet groups
time frame: 3 hours
description: Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
measure: Difference in the iAUC for insulin after food ingestion between high-protein and standard diet groups
time frame: 3 hours
description: Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
measure: Difference in the iAUC for C-peptide after food ingestion between high-protein and standard diet groups
time frame: 3 hours
description: Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
measure: Difference in the iAUC for glucagon after food ingestion between high-protein and standard diet groups
time frame: 3 hours
description: Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
arm group label: High-protein diet
arm group type: Experimental
arm group label: Standard diet
arm group type: Active Comparator
intervention type: Dietary Supplement
intervention name: High-protein diet
description: The high-protein diet is made up of 50% carbohydrate, 40% of protein and 10% of fat, providing 480 kcal.
A protein part of the high-protein diet is mostly composed of a grilled Jeju red horsehead fish, a special product of Jeju island in Korea.
arm group label: High-protein diet
other name: A Jeju red horsehead fish-based meal
intervention type: Dietary Supplement
intervention name: Standard diet
description: The standard diet is made up of 60% carbohydrate, 20% of protein and 20% of fat, providing 480 kcal.
arm group label: Standard diet
other name: A mixed meal
criteria: 
gender: All
minimum age: 20 Years
maximum age: 79 Years
healthy volunteers: No
last name: Gwanpyo Koh, Professor
role: Principal Investigator
affiliation: Jeju National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Jeju National University Hospital
investigator full name: Gwanpyo Koh
investigator title: Associate professor
mesh term: Diabetes Mellitus