<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/NCT03307486</url>
  </required_header>
  <id_info>
    <org_study_id>48868915.9.0000.0068</org_study_id>
    <nct_id>NCT03307486</nct_id>
  </id_info>
  <brief_title>Gestational Diabetes: a Cohort Study</brief_title>
  <official_title>Fetal and Maternal Repercussions of Gestational Diabetes After the Adoption of the Diagnostic Criteria Proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG): a Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gestational diabetes (GDM) is the most common hormonal complication during pregnancy. Its&#xD;
      occurrence implies an increased risk of maternal and fetal complications and, therefore, its&#xD;
      diagnosis and treatment are extremely important. Since the adoption of the new diagnostic&#xD;
      criteria proposed by the International Association of Diabetes and Pregnancy Study Groups&#xD;
      (IADPSG) in 2010, an increasing number of cases of mild hyperglycemia have demanded follow-up&#xD;
      and treatment. The need and benefit of treatment in these cases of mild hyperglycemia has&#xD;
      been discussed worldwide. Women who have been diagnosed with GDM are at increased risk for&#xD;
      type 2 DM in the years following gestation. Other factors (such as lipid profile, obesity,&#xD;
      adipokine dosage) may also be related to the repercussions of GDM on the maternal-fetal&#xD;
      binomial, since gestations with satisfactory glycemic control can also present complications&#xD;
      related to the disease and increased risk of type 2 DM in the long term. The present study&#xD;
      aims to investigate factors associated with the need for insulin use, the occurrence of&#xD;
      perinatal complications, nutritional status, physical activity and weight retention one year&#xD;
      after delivery and the postpartum diagnosis of type 2 DM 10 years after delivery in women&#xD;
      diagnosed with GDM according to the current criteria suggested by the IADPSG.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">September 17, 2015</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">June 2030</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of type 2 DM after GDM</measure>
    <time_frame>10 years</time_frame>
    <description>To evaluate clinical, nutritional and laboratory factors as tools to predict the diagnosis of type 2 DM, carbohydrate intolerance or postpartum metabolic syndrome in women who had GDM</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Need of insulin</measure>
    <time_frame>during pregnancy</time_frame>
    <description>To evaluate clinical and laboratory factors as tools to predict the need of insulin during pregnancy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight at birth</measure>
    <time_frame>during pregnancy and delivery</time_frame>
    <description>To evaluate clinical, ultrasonographic and laboratory factors as tools to predict weight at birth (grams)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Route of delivery</measure>
    <time_frame>during pregnancy and delivery</time_frame>
    <description>To evaluate clinical, ultrasonographic and laboratory factors as tools to predict the route of delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal Hypoglycemia</measure>
    <time_frame>during pregnancy and delivery</time_frame>
    <description>To evaluate clinical, ultrasonographic and laboratory factors as tools to predict neonatal hypoglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obesity in the offspring</measure>
    <time_frame>10 years</time_frame>
    <description>To evaluate clinical, ultrasonographic and laboratory factors as tools to predict obesity in the offspring of women with GDM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertension in the offspring</measure>
    <time_frame>10 years</time_frame>
    <description>To evaluate clinical, ultrasonographic and laboratory factors as tools to predict hypertension in the offspring of women with GDM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>during pregnancy, 6 months postpartum and one year after delivery</time_frame>
    <description>To assess the body composition of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>during pregnancy , 6 months postpartum and 1 year after delivery</time_frame>
    <description>identify the level of daily physical activity of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eating habits</measure>
    <time_frame>during pregnancy, 6 months postpartum and 1 year after delivery</time_frame>
    <description>to verify the eating habits of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight retention</measure>
    <time_frame>during pregnancy, 6 months postpartum and 1 year after delivery</time_frame>
    <description>To study association between levels of physical activity and dietary intake and the weight retention in women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Route of delivery vs physical activity</measure>
    <time_frame>during pregnancy and delivery</time_frame>
    <description>to study association between the level of physical activity in women with gestational diabetes during pregnancy and the route of delivery (cesarian or vaginal birth)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Route of delivery vs eating habits</measure>
    <time_frame>during pregnancy and delivery</time_frame>
    <description>to study association between the eating habits in women with gestational diabetes during pregnancy and the route of delivery (cesarian or vaginal birth)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal weight at birth vs physical activity</measure>
    <time_frame>during pregnancy and delivery</time_frame>
    <description>to study association between physical activity in women with gestational diabetes during pregnancy and the fetal weight at delivery (grams)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal weight at birth vs eating habits</measure>
    <time_frame>during pregnancy and delivery</time_frame>
    <description>to study association between eating habits in women with gestational diabetes during pregnancy and the fetal weight at delivery (grams)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1400</enrollment>
  <condition>Gestational Diabetes</condition>
  <condition>Diabetes, Gestational</condition>
  <condition>Diabetes Mellitus in Pregnancy</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Gestational diabetes</arm_group_label>
    <description>Women diagnosed with GDM according to the IADPSG criteria, either by abnormal fasting plasma glucose or by abnormal oral glucose tolerance test.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who were diagnosed with gestational diabetes after the adoption of the diagnostic&#xD;
        criteria proposed by the IADPSG (June 2011) will be evaluated retrospectively and&#xD;
        prospectively in the high-risk prenatal outpatient clinic of the Obstetric Clinic of the&#xD;
        Hospital das Clínicas of the Medical School of the University of São Paulo (HCFMUSP), a&#xD;
        tertiary teaching hospital in Sao Paulo, Brazil.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  single pregnancies&#xD;
&#xD;
          -  absence of glucose intolerance prior to gestation (defined by prior diagnosis of&#xD;
             polycystic ovarian syndrome or fasting glycemia ≥100mg / dl or 2hr post-overload with&#xD;
             75g glucose ≥ 140mg / dL or glycated hemoglobin ≥ 5.7% previously to pregnancy)&#xD;
&#xD;
          -  absence of chronic use of glucocorticoids or antiretroviral drugs for HIV virus, given&#xD;
             its diabetogenic effect and potential confounding&#xD;
&#xD;
          -  diagnosis of GDM according to diagnostic criteria proposed by the IADPSG, namely:&#xD;
             initial fasting blood glucose ≥ 92mg / dL OR oral glucose tolerance test of 75g with&#xD;
             fasting ≥ 92mg / dL or after1h ≥ 180mg / dL or after 2h ≥ 153mg / dL&#xD;
&#xD;
          -  Agreement with the informed consent term for patients who will be followed&#xD;
             prospectively&#xD;
&#xD;
          -  Agreement with the free and informed consent term for recall and reassessment of the&#xD;
             patients identified in the retrospective analysis of the data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  loss to follow up during pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05403000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gestational diabetes</keyword>
  <keyword>Type 2 DM after GDM</keyword>
  <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>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT03307486
org study id: 48868915.9.0000.0068
nct id: NCT03307486
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gestational diabetes (GDM) is the most common hormonal complication during pregnancy. Its
      occurrence implies an increased risk of maternal and fetal complications and, therefore, its
      diagnosis and treatment are extremely important. Since the adoption of the new diagnostic
      criteria proposed by the International Association of Diabetes and Pregnancy Study Groups
      (IADPSG) in 2010, an increasing number of cases of mild hyperglycemia have demanded follow-up
      and treatment. The need and benefit of treatment in these cases of mild hyperglycemia has
      been discussed worldwide. Women who have been diagnosed with GDM are at increased risk for
      type 2 DM in the years following gestation. Other factors (such as lipid profile, obesity,
      adipokine dosage) may also be related to the repercussions of GDM on the maternal-fetal
      binomial, since gestations with satisfactory glycemic control can also present complications
      related to the disease and increased risk of type 2 DM in the long term. The present study
      aims to investigate factors associated with the need for insulin use, the occurrence of
      perinatal complications, nutritional status, physical activity and weight retention one year
      after delivery and the postpartum diagnosis of type 2 DM 10 years after delivery in women
      diagnosed with GDM according to the current criteria suggested by the IADPSG.
observational model: Cohort
time perspective: Prospective
measure: Occurrence of type 2 DM after GDM
time frame: 10 years
description: To evaluate clinical, nutritional and laboratory factors as tools to predict the diagnosis of type 2 DM, carbohydrate intolerance or postpartum metabolic syndrome in women who had GDM
measure: Need of insulin
time frame: during pregnancy
description: To evaluate clinical and laboratory factors as tools to predict the need of insulin during pregnancy
measure: Weight at birth
time frame: during pregnancy and delivery
description: To evaluate clinical, ultrasonographic and laboratory factors as tools to predict weight at birth (grams)
measure: Route of delivery
time frame: during pregnancy and delivery
description: To evaluate clinical, ultrasonographic and laboratory factors as tools to predict the route of delivery
measure: Neonatal Hypoglycemia
time frame: during pregnancy and delivery
description: To evaluate clinical, ultrasonographic and laboratory factors as tools to predict neonatal hypoglycemia
measure: Obesity in the offspring
time frame: 10 years
description: To evaluate clinical, ultrasonographic and laboratory factors as tools to predict obesity in the offspring of women with GDM
measure: Hypertension in the offspring
time frame: 10 years
description: To evaluate clinical, ultrasonographic and laboratory factors as tools to predict hypertension in the offspring of women with GDM
measure: Body composition
time frame: during pregnancy, 6 months postpartum and one year after delivery
description: To assess the body composition of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum
measure: Physical activity
time frame: during pregnancy , 6 months postpartum and 1 year after delivery
description: identify the level of daily physical activity of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum
measure: Eating habits
time frame: during pregnancy, 6 months postpartum and 1 year after delivery
description: to verify the eating habits of women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum
measure: Weight retention
time frame: during pregnancy, 6 months postpartum and 1 year after delivery
description: To study association between levels of physical activity and dietary intake and the weight retention in women with gestational diabetes during pregnancy, 6 months postpartum and one year postpartum
measure: Route of delivery vs physical activity
time frame: during pregnancy and delivery
description: to study association between the level of physical activity in women with gestational diabetes during pregnancy and the route of delivery (cesarian or vaginal birth)
measure: Route of delivery vs eating habits
time frame: during pregnancy and delivery
description: to study association between the eating habits in women with gestational diabetes during pregnancy and the route of delivery (cesarian or vaginal birth)
measure: Fetal weight at birth vs physical activity
time frame: during pregnancy and delivery
description: to study association between physical activity in women with gestational diabetes during pregnancy and the fetal weight at delivery (grams)
measure: Fetal weight at birth vs eating habits
time frame: during pregnancy and delivery
description: to study association between eating habits in women with gestational diabetes during pregnancy and the fetal weight at delivery (grams)
arm group label: Gestational diabetes
description: Women diagnosed with GDM according to the IADPSG criteria, either by abnormal fasting plasma glucose or by abnormal oral glucose tolerance test.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2