<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/NCT01675310</url>
  </required_header>
  <id_info>
    <org_study_id>Conacyt 151819</org_study_id>
    <secondary_id>INPer (Mexico)</secondary_id>
    <nct_id>NCT01675310</nct_id>
  </id_info>
  <brief_title>Medical Nutrition Therapy Plus Transgestational Metformin For Preventing Gestational Diabetes In High Risk Mexican Women</brief_title>
  <official_title>EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Council of Science and Technology, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that&#xD;
      affect between 1 to 14% of population around the world.&#xD;
&#xD;
      There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican&#xD;
      population.&#xD;
&#xD;
      Metformin has been used during pregnancy in women with gestational diabetes and women with&#xD;
      polycystic ovary syndrome, with acceptable security for mother and fetus.&#xD;
&#xD;
      Metformin decrease the insulin resistance and weight gain, we believe that metformin may be&#xD;
      decrease the risk of gestational diabetes mellitus in high risk women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gestational diabetes mellitus</measure>
    <time_frame>27-28 weeks of gestation</time_frame>
    <description>oral glucose tolerance test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>insulin resistance</measure>
    <time_frame>At birth</time_frame>
    <description>measure of insulin resistance by HOMA-IR, sample of umbilical cord</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Pregestational Obesity (BMI &gt; 27kg/m2)</condition>
  <condition>History of Polycystic Ovary Syndrome</condition>
  <arm_group>
    <arm_group_label>medical nutrition therapy + metformin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>medical nutrition therapy plus trans-gestational metformin (850mg 2 times day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>medical nutrition therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>medical nutrition therapy without trans-gestational metformin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>medical nutrition therapy + metformin</intervention_name>
    <arm_group_label>medical nutrition therapy + metformin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Medical nutrition therapy</intervention_name>
    <description>medical nutrition therapy</description>
    <arm_group_label>medical nutrition therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mexican women with pregnancy &lt; 16 weeks of gestation, normal oral glucose tolerance&#xD;
             75g-2h test and 3 or more criteria:&#xD;
&#xD;
               1. Body mass index &gt; 27 kg/m2&#xD;
&#xD;
               2. Maternal age &gt;25&#xD;
&#xD;
               3. History of infertility with polycystic ovary syndrome&#xD;
&#xD;
               4. History of macrosomic newborn (Weight &gt;4000g)&#xD;
&#xD;
               5. History of diabetes mellitus in first or second degree.&#xD;
&#xD;
               6. History of gestational diabetes in previous pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any form of pregestational diabetes&#xD;
&#xD;
          -  Fasting glucose &gt; 126 mg/dL at first prenatal visit.&#xD;
&#xD;
          -  seric creatinine &gt; 1.5 mg/dL&#xD;
&#xD;
          -  Hyperthyroidism&#xD;
&#xD;
          -  Heart disease&#xD;
&#xD;
          -  Hepatic disease&#xD;
&#xD;
          -  Renal diseases&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Lupus&#xD;
&#xD;
          -  Chronic hypertension.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Enrique Reyes-Muñoz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Perinatology, Mexico City</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institute of Perinatology</name>
      <address>
        <city>Mexico</city>
        <zip>11000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <link>
    <url>http://journals.lww.com/greenjournal/Abstract/2014/05001/Medical_Nutrition_Therapy_Plus_Metformin_for.346.aspx</url>
    <description>Medical Nutrition Therapy Plus Metformin for Preventing Gestational Diabetes Among High-Risk Women.</description>
  </link>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>March 23, 2015</last_update_submitted>
  <last_update_submitted_qc>March 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 25, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes</investigator_affiliation>
    <investigator_full_name>ENRIQUE REYES-Munoz MD</investigator_full_name>
    <investigator_title>Clinical Reseach</investigator_title>
  </responsible_party>
  <keyword>obesity, polycystic ovary syndrome, gestational diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Diabetes, Gestational</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</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/NCT01675310
org study id: Conacyt 151819
secondary id: INPer (Mexico)
nct id: NCT01675310
lead sponsor: 
collaborator: 
has dmc: Yes
Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that
      affect between 1 to 14% of population around the world.

      There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican
      population.

      Metformin has been used during pregnancy in women with gestational diabetes and women with
      polycystic ovary syndrome, with acceptable security for mother and fetus.

      Metformin decrease the insulin resistance and weight gain, we believe that metformin may be
      decrease the risk of gestational diabetes mellitus in high risk women.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Gestational diabetes mellitus
time frame: 27-28 weeks of gestation
description: oral glucose tolerance test
measure: insulin resistance
time frame: At birth
description: measure of insulin resistance by HOMA-IR, sample of umbilical cord
arm group label: medical nutrition therapy + metformin
arm group type: Experimental
description: medical nutrition therapy plus trans-gestational metformin (850mg 2 times day)
arm group label: medical nutrition therapy
arm group type: Active Comparator
description: medical nutrition therapy without trans-gestational metformin
intervention type: Drug
intervention name: medical nutrition therapy + metformin
arm group label: medical nutrition therapy + metformin
intervention type: Behavioral
intervention name: Medical nutrition therapy
description: medical nutrition therapy
arm group label: medical nutrition therapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Enrique Reyes-Muñoz, PhD
role: Principal Investigator
affiliation: National Institute of Perinatology, Mexico City
facility: 
country: Mexico
url: http://journals.lww.com/greenjournal/Abstract/2014/05001/Medical_Nutrition_Therapy_Plus_Metformin_for.346.aspx
description: Medical Nutrition Therapy Plus Metformin for Preventing Gestational Diabetes Among High-Risk Women.
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
investigator full name: ENRIQUE REYES-Munoz MD
investigator title: Clinical Reseach
mesh term: Polycystic Ovary Syndrome
mesh term: Diabetes, Gestational
mesh term: Metformin