<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/NCT02225951</url>
  </required_header>
  <id_info>
    <org_study_id>GDM.1.C/A</org_study_id>
    <nct_id>NCT02225951</nct_id>
  </id_info>
  <brief_title>Meal Tolerance Trial in Pregnant Women Diagnosed With Gestational Diabetes Mellitus.</brief_title>
  <acronym>GDM-MTT</acronym>
  <official_title>A Randomised, Controlled, Open-label Trial to Investigate the Effect of a New Nutritional Supplement on Postprandial Glucose Response in Women Diagnosed With Gestational Diabetes Mellitus.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danone Asia Pacific Holdings Pte, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nutricia Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Danone Asia Pacific Holdings Pte, Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is initiated to investigate the effect of a nutritional product on the 3-hr&#xD;
      postprandial glucose response compared to a control standard breakfast at baseline and after&#xD;
      4 weeks of intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the study is to investigate the effect of study product on the&#xD;
      3-hour postprandial glucose response compared to a controlled standard breakfast at baseline&#xD;
      and after 4 weeks of intervention. Secondary objectives include investigation on the effect&#xD;
      of the product compared to a control standard breakfast to the 3-hr postprandial insulin&#xD;
      response, postprandial peak and delta peak concentration of glucose and insulin, fasting&#xD;
      concentration of glucose and insulin, and insulin resistance as calculated by the HOMA index.&#xD;
      The study also aims to measure compliance, study product intake and appreciation, safety and&#xD;
      tolerance to study product, as well as satiety, daily energy and nutrient intake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Current protocol is not optimal/feasible&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3-hr postprandial glucose response</measure>
    <time_frame>28 days</time_frame>
    <description>To investigate the effect of a nutritional product on the 3-hr postprandial glucose response compared to a control standard breakfast at baseline and after 4 weeks of intervention</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Gestational Diabetes Mellitus in Pregnancy</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nutritional product as breakfast.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard breakfast according to ADA recommendations for pregnant women diagnosed with Gestational Diabetes Mellitus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Nutritional product</intervention_name>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard breakfast according to ADA recommendations</intervention_name>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant women, aged 18-40 years&#xD;
&#xD;
          2. 18.5 kg/m2 &lt; pre-pregnancy BMI &lt; 27.5 kg/m2 [representing low to moderate risk&#xD;
             category, adapted from WHO expert panel recommendation on BMI categories for&#xD;
             determining public health and clinical action (REF: Lancet, 2004)]&#xD;
&#xD;
          3. Singleton pregnancy&#xD;
&#xD;
          4. Newly GDM diagnosed women between 24 to (the latest) 32 weeks of gestation;&#xD;
&#xD;
          5. Diagnosed GDM according to either:&#xD;
&#xD;
               -  World Health Organization (WHO) criteria if one or more glucose values equal to&#xD;
                  or exceed these threshold values [75g Oral Glucose Tolerance Test: fasting 126&#xD;
                  mg/dl; 2-h 140 mg/dl] or&#xD;
&#xD;
               -  American Diabetic Association (ADA) criteria if two or more glucose values equal&#xD;
                  to or exceed these threshold values [100g Oral Glucose Tolerance Test: fasting 95&#xD;
                  mg/dl; 1-h 180 mg/dl; 2-h 155 mg/dl, 3-h 140/dl]&#xD;
&#xD;
          6. Willing and able to comply with the protocol&#xD;
&#xD;
          7. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any gastrointestinal disease that interferes with bowel function and nutritional&#xD;
             intake (i.e. constipation or diarrhea secondary to neuropathy, diarrhea due to chronic&#xD;
             inflammatory bowel disease, gastroparesis, gastrectomy, galactosaemia, hyperemesis)&#xD;
&#xD;
          2. Currently on anti-diabetic therapy, for example on insulin or oral anti-diabetic&#xD;
             medication&#xD;
&#xD;
          3. Already using a diabetes nutritional/dietary supplement (e.g. Glucerna®, Nutrient&#xD;
             Diabetes®) within 4 weeks prior to signing informed consent&#xD;
&#xD;
          4. Known allergy or intolerance for any of the following ingredients; fish, milk,&#xD;
             protein, lactose, fiber or soy&#xD;
&#xD;
          5. Any significant medical condition, other than GDM, that might interfere with the study&#xD;
             or known to affect intra-uterine growth (e.g. Type 1 Diabetes, Type 2 Diabetes&#xD;
             Mellitus, Crohn's disease, HIV/AIDS, liver disease, kidney disease etc.)&#xD;
&#xD;
          6. Currently or previously on special low/no carbohydrate diet (e.g. Atkin's diet) within&#xD;
             8 weeks prior to signing informed consent&#xD;
&#xD;
          7. Incapability to comply with study protocol or Investigator's uncertainty about the&#xD;
             willingness or ability of the subject to comply with the protocol requirements&#xD;
&#xD;
          8. Participation in other studies involving investigational or marketed products&#xD;
             concomitantly or within 4 weeks prior signing informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kok Hian Tan, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>KKH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KK Women's and Children's Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>229899</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>September 4, 2017</last_update_submitted>
  <last_update_submitted_qc>September 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Pregnancy in Diabetics</mesh_term>
    <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/NCT02225951
org study id: GDM.1.C/A
nct id: NCT02225951
lead sponsor: 
collaborator: 
has dmc: No
This study is initiated to investigate the effect of a nutritional product on the 3-hr
      postprandial glucose response compared to a control standard breakfast at baseline and after
      4 weeks of intervention.
The primary objective of the study is to investigate the effect of study product on the
      3-hour postprandial glucose response compared to a controlled standard breakfast at baseline
      and after 4 weeks of intervention. Secondary objectives include investigation on the effect
      of the product compared to a control standard breakfast to the 3-hr postprandial insulin
      response, postprandial peak and delta peak concentration of glucose and insulin, fasting
      concentration of glucose and insulin, and insulin resistance as calculated by the HOMA index.
      The study also aims to measure compliance, study product intake and appreciation, safety and
      tolerance to study product, as well as satiety, daily energy and nutrient intake.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: 3-hr postprandial glucose response
time frame: 28 days
description: To investigate the effect of a nutritional product on the 3-hr postprandial glucose response compared to a control standard breakfast at baseline and after 4 weeks of intervention
arm group label: Test group
arm group type: Active Comparator
description: Nutritional product as breakfast.
arm group label: Control Group
arm group type: Other
description: Standard breakfast according to ADA recommendations for pregnant women diagnosed with Gestational Diabetes Mellitus.
intervention type: Dietary Supplement
intervention name: Nutritional product
arm group label: Test group
intervention type: Other
intervention name: Standard breakfast according to ADA recommendations
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Kok Hian Tan, MBBS
role: Principal Investigator
affiliation: KKH
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus