<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/NCT04429958</url>
  </required_header>
  <id_info>
    <org_study_id>S64070</org_study_id>
    <nct_id>NCT04429958</nct_id>
  </id_info>
  <brief_title>The Belgian Diabetes in Pregnancy Follow-up Study</brief_title>
  <acronym>BEDIP-FUS</acronym>
  <official_title>The Belgian Diabetes in Pregnancy Follow-up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Onze Lieve Vrouw Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Imelda Bonheiden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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 a form of diabetes that develops during pregnancy. GDM is&#xD;
      associated with increased risks for pregnancy complications such as macrosomia s and preterm&#xD;
      delivery. Women with a history of GDM have a high risk to develop a type 2 diabetes (T2DM)&#xD;
      within the next ten years after delivery. The children are also at increased risk of&#xD;
      developing obesity and T2DM later in life. Studies are needed to find more accurate&#xD;
      predictors for the metabolic risk later in life. This will help to individualize the&#xD;
      follow-up and to develop tailored prevention strategies in women and offspring with a history&#xD;
      of GDM. In this research project we will therefore investigate how the long-term metabolic&#xD;
      risk can more accurately be predicted in a follow-up cohort of the 'Belgian Diabetes in&#xD;
      Pregnancy study' (BEDIP-N). We will study the relationship between maternal weight, degree of&#xD;
      body fat and degree of hyperglycaemia in pregnancy on the long-term metabolic risk of 375&#xD;
      women and offspring pairs 3-7 years after the delivery across different gestational glucose&#xD;
      tolerance groups based on the 2013 WHO criteria in pregnancy. In addition, we will study&#xD;
      whether a promising new biomarker, glycated CD59, is a good predictor for the long-term&#xD;
      metabolic risk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 25, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</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>A disorder of glucose metabolism in mothers</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>T2DM defined by the 75g OGTT and/or HbA1c, or prediabetes defined by the American Diabetes Association (ADA) criteria</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI in offspring</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>BMI z score as a continuous variable</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI in mothers</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>BMI as continuous variable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metabolic syndrome in mothers</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>The metabolic syndrome based on the WHO criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity mothers Matsuda</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>Insulin sensitivity measured by the insulin sensitivity index of Matsuda</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity mothers HOMA</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>Insulin sensitivity measured by the reciprocal of the homeostasis model assessment of insulin resistance (1/HOMA-IR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beta-cell function mothers HOMA-B</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>Beta-cell function by the HOMA-B index and the insulinogenic index divided by HOMA-IR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beta-cell function mothers ISSI-2</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>Beta-cell function measured by the insulin-secretion sensitivity-2 index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beta-cell function mothers Stumvoll</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>Beta-cell function measured by the Stumvoll index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adiposity mothers BIA</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adiposity mothers skin folds</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>Adiposity (as a continuous variable) measured by skin folds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overweight offspring</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>overweight defined by BMI z score according to the WHO guidelines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>obesity offspring</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>obesity defined by BMI z score according to the WHO guidelines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A disorder of glucose metabolism in offspring</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>T2DM and prediabetes based on the fasting plasma glucoseand/or HbA1c defined by the ADA criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>metabolic syndrome in offsping</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>metabolic syndrome based on the WHO criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>insulin sensitivity offspring</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>insulin sensitivity measured by HOMA-IR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beta-cell function offsping</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>Beta-cell function by the HOMA-B index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adiposity offsping BIA</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adiposity offsping skin folds</measure>
    <time_frame>3-7 years after delivery</time_frame>
    <description>Adiposity (as a continuous variable) measured by skin folds</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">750</enrollment>
  <condition>Gestational Diabetes</condition>
  <condition>Type2 Diabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>GDM</arm_group_label>
    <description>125 mothers with a history of GDM in pregnancy at the time of the BEDIP study and their offspring born during the BEDIP study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>abnormal GCT group</arm_group_label>
    <description>125 mothers with an abnormal glucose challange test (GCT of 130mg/dl or more) in pregnancy at the time of the BEDIP study and their offspring born during the BEDIP study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal group</arm_group_label>
    <description>125 mothers with both a normal GCT and OGT in pregnancy at the time of the BEDIP study and their offspring born during the BEDIP study</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GDM</intervention_name>
    <description>different degrees of hyperglycaemia during pregnancy</description>
    <arm_group_label>GDM</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We plan to recruit 375 women-offspring pairs with the five largest centers who participated&#xD;
        in the initial BEDIP study. Women and offspring will be recruited according to 3 different&#xD;
        subgroups based on the antenatal result of the GCT and OGTT in the index pregnancy (a&#xD;
        sample of 125 in each group): GDM group; normal glucose tolerance (NGT) on the OGTT with an&#xD;
        abnormal preceding GCT (abnormal GCT NGT group); NGT on the OGTT with a normal preceding&#xD;
        GCT (normal GCT NGT group). Abnormal GCT is defined as glucose≥130mg/dl, in line with our&#xD;
        previous research.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mothers who participated in the completed BEDIP-N study and received both the GCT as&#xD;
             the OGTT during pregnancy&#xD;
&#xD;
          -  Offspring born at the time of participation in the BEDIP-N study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mothers:&#xD;
&#xD;
               -  Current pregnancy&#xD;
&#xD;
               -  Treatment that influences glycaemic status such as high dose corticoids.&#xD;
&#xD;
               -  History of bariatric surgery&#xD;
&#xD;
               -  gastro-intestinal surgery changing the absorption of glucose (Billroth II)&#xD;
&#xD;
               -  A normal study visit will not be possible (incompliance, psychiatric problems…)&#xD;
&#xD;
               -  Diagnosed with type 1 diabetes or the presence of auto-immune antibodies for type&#xD;
                  1 diabetes&#xD;
&#xD;
        Offspring:&#xD;
&#xD;
          -  Treatment that influences glycaemic status such as high dose corticoids.&#xD;
&#xD;
          -  A normal study visit will not be possible (incompliance, psychiatric problems…)&#xD;
&#xD;
          -  Diagnosed with type 1 diabetes or the presence of auto-immune antibodies for type 1&#xD;
             diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katrien Benhalima</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katrien Benhalima</last_name>
    <phone>+3216340614</phone>
    <email>katrien.benhalima@uzleuven.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>OLV-Alast</name>
      <address>
        <city>Aalst</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Inge Van Pottelbergh</last_name>
      <email>Inge.Van.Pottelbergh@olvz-aalst.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UZA</name>
      <address>
        <city>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eveline Dirinck</last_name>
      <email>Eveline.Dirinck@uza.be</email>
    </contact>
    <contact_backup>
      <last_name>Kim Van Hoorenbeeck</last_name>
      <email>Kim.VanHoorenbeeck@uza.be</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>OLV-Asse</name>
      <address>
        <city>Asse</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Inge Van Pottelbergh</last_name>
      <email>Inge.Van.Pottelbergh@olvz-aalst.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Imelda Bonheiden</name>
      <address>
        <city>Bonheiden</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Toon Maes</last_name>
      <email>Toon.Maes@imelda.be</email>
    </contact>
    <contact_backup>
      <last_name>Chris Vercammen</last_name>
      <email>Chris.Vercammen@imelda.be</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katrien Benhalima, MD PhD</last_name>
      <email>katrien.benhalima@uzleuven.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>October 10, 2022</last_update_submitted>
  <last_update_submitted_qc>October 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04429958
org study id: S64070
nct id: NCT04429958
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gestational diabetes (GDM) is a form of diabetes that develops during pregnancy. GDM is
      associated with increased risks for pregnancy complications such as macrosomia s and preterm
      delivery. Women with a history of GDM have a high risk to develop a type 2 diabetes (T2DM)
      within the next ten years after delivery. The children are also at increased risk of
      developing obesity and T2DM later in life. Studies are needed to find more accurate
      predictors for the metabolic risk later in life. This will help to individualize the
      follow-up and to develop tailored prevention strategies in women and offspring with a history
      of GDM. In this research project we will therefore investigate how the long-term metabolic
      risk can more accurately be predicted in a follow-up cohort of the 'Belgian Diabetes in
      Pregnancy study' (BEDIP-N). We will study the relationship between maternal weight, degree of
      body fat and degree of hyperglycaemia in pregnancy on the long-term metabolic risk of 375
      women and offspring pairs 3-7 years after the delivery across different gestational glucose
      tolerance groups based on the 2013 WHO criteria in pregnancy. In addition, we will study
      whether a promising new biomarker, glycated CD59, is a good predictor for the long-term
      metabolic risk.
observational model: Cohort
time perspective: Prospective
measure: A disorder of glucose metabolism in mothers
time frame: 3-7 years after delivery
description: T2DM defined by the 75g OGTT and/or HbA1c, or prediabetes defined by the American Diabetes Association (ADA) criteria
measure: BMI in offspring
time frame: 3-7 years after delivery
description: BMI z score as a continuous variable
measure: BMI in mothers
time frame: 3-7 years after delivery
description: BMI as continuous variable
measure: metabolic syndrome in mothers
time frame: 3-7 years after delivery
description: The metabolic syndrome based on the WHO criteria
measure: Insulin sensitivity mothers Matsuda
time frame: 3-7 years after delivery
description: Insulin sensitivity measured by the insulin sensitivity index of Matsuda
measure: Insulin sensitivity mothers HOMA
time frame: 3-7 years after delivery
description: Insulin sensitivity measured by the reciprocal of the homeostasis model assessment of insulin resistance (1/HOMA-IR)
measure: Beta-cell function mothers HOMA-B
time frame: 3-7 years after delivery
description: Beta-cell function by the HOMA-B index and the insulinogenic index divided by HOMA-IR
measure: Beta-cell function mothers ISSI-2
time frame: 3-7 years after delivery
description: Beta-cell function measured by the insulin-secretion sensitivity-2 index
measure: Beta-cell function mothers Stumvoll
time frame: 3-7 years after delivery
description: Beta-cell function measured by the Stumvoll index
measure: Adiposity mothers BIA
time frame: 3-7 years after delivery
description: Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis
measure: Adiposity mothers skin folds
time frame: 3-7 years after delivery
description: Adiposity (as a continuous variable) measured by skin folds
measure: overweight offspring
time frame: 3-7 years after delivery
description: overweight defined by BMI z score according to the WHO guidelines
measure: obesity offspring
time frame: 3-7 years after delivery
description: obesity defined by BMI z score according to the WHO guidelines
measure: A disorder of glucose metabolism in offspring
time frame: 3-7 years after delivery
description: T2DM and prediabetes based on the fasting plasma glucoseand/or HbA1c defined by the ADA criteria
measure: metabolic syndrome in offsping
time frame: 3-7 years after delivery
description: metabolic syndrome based on the WHO criteria
measure: insulin sensitivity offspring
time frame: 3-7 years after delivery
description: insulin sensitivity measured by HOMA-IR
measure: Beta-cell function offsping
time frame: 3-7 years after delivery
description: Beta-cell function by the HOMA-B index
measure: Adiposity offsping BIA
time frame: 3-7 years after delivery
description: Adiposity (as a continuous variable) measured by the bioelectrical impedance analysis
measure: Adiposity offsping skin folds
time frame: 3-7 years after delivery
description: Adiposity (as a continuous variable) measured by skin folds
arm group label: GDM
description: 125 mothers with a history of GDM in pregnancy at the time of the BEDIP study and their offspring born during the BEDIP study
arm group label: abnormal GCT group
description: 125 mothers with an abnormal glucose challange test (GCT of 130mg/dl or more) in pregnancy at the time of the BEDIP study and their offspring born during the BEDIP study
arm group label: normal group
description: 125 mothers with both a normal GCT and OGT in pregnancy at the time of the BEDIP study and their offspring born during the BEDIP study
intervention type: Other
intervention name: GDM
description: different degrees of hyperglycaemia during pregnancy
arm group label: GDM
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: N/A
healthy volunteers: No
last name: Katrien Benhalima
role: Principal Investigator
affiliation: UZ Leuven
last name: Katrien Benhalima
phone: +3216340614
email: katrien.benhalima@uzleuven.be
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus
sharing ipd: No