<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/NCT04417452</url>
  </required_header>
  <id_info>
    <org_study_id>2019-1403</org_study_id>
    <nct_id>NCT04417452</nct_id>
  </id_info>
  <brief_title>Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy</brief_title>
  <acronym>MuKiLOG</acronym>
  <official_title>Effects of Fetal Programming on the Metabolic, Cardiovascular, Neurocognitive and Reproductive Health of Offsprings and Their Mothers After Pregnancies With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jena University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jena University 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>
      The primary objectives of the proposed project are to assess the long-term effects of&#xD;
      prenatal exposure to gestational diabetes or diabetes on the maturation and health of the&#xD;
      offspring. In addition, the long-term changes on the health of the affected mothers will be&#xD;
      investigated, taking into account the metabolic adjustment during index pregnancy. The&#xD;
      expected results will help to establish possible prevention strategies to fight the epidemic&#xD;
      of non-communicable diseases for the offspring and the mothers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigation of the long-term outcome of mother-child pairs after diabetic pregnancies and a&#xD;
      comparison group regarding metabolic, cardiovascular, neurocognitive and reproductive&#xD;
      long-term changes as a function of the course of pregnancy and metabolic control&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">October 25, 2022</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>Metabolic health</measure>
    <time_frame>1 day examination at the study centre</time_frame>
    <description>effects on metabolic health such as glucose tolerance disorders and diabetes mellitus, obesity and metabolic syndrome (mothers and children)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurocognitive development</measure>
    <time_frame>1 day examination at the study centre</time_frame>
    <description>effects on neurocognitive development, mental health and adrenal and autonomic stress reactivity (mothers and children)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiovascular and vascular health</measure>
    <time_frame>1 day examination at the study centre</time_frame>
    <description>effects on cardiovascular and vascular health of blood pressure regulation and endothelial function (mothers and children)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maturation of the gonadal regulation</measure>
    <time_frame>1 day examination at the study centre</time_frame>
    <description>maturation of gonadal regulation, pubertal development and reproductive health (children)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Diabetes, Gestational</condition>
  <condition>Pregnancy Diabetic</condition>
  <arm_group>
    <arm_group_label>Mothers / children after diabetes in pregnancy</arm_group_label>
    <description>The study collective is composed of mother-child pairs after gestational diabetes, which were supervised in the Competence Center for Diabetes and Pregnancy at the University Hospital of Jena. The patients can decide to fill in an online questionnaire. For all other parts of the study, only patients who have been informed individually or on behalf of their legal guardian about the nature of the study after a detailed and understandable explanatory discussion with an investigator and who have given written consent will be included in the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>The control collective is composed of mother-child pairs who were cared for at the same time as the study collective at the University Hospital Jena. This collective is status post singleton pregnancy and term birth. The patients can decide to fill in an online questionnaire. For all other parts of the study, only patients who have been informed individually or on behalf of their legal guardian about the nature of the study after a detailed and understandable explanatory discussion with an investigator and who have given written consent will be included in the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Basic data collection (online survey or written form)</intervention_name>
    <description>Basic data collection is carried out by means of a questionnaire that participants can fill in outside the study centre. It contains questions about the current life situation, sleep and activity behaviour.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Mothers / children after diabetes in pregnancy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical examination</intervention_name>
    <description>The physical examination takes place at the study centre and includes the measurement of height, current weight and body fat, as well as the recording of heart and circulation parameters (e.g. blood pressure measurement or determination of vascular health by means of ultrasound). General metabolic and hormonal parameters are analysed by means of a blood sample. In addition, a sugar test for diabetes diagnosis will be carried out.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Mothers / children after diabetes in pregnancy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychometric examination</intervention_name>
    <description>Psychometric examination is carried out at the study centre with the help of a RIAS (Reynolds Intellectual Assessment Scales and Screening) test.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Mothers / children after diabetes in pregnancy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Recording of the adrenergic stress reaction (saliva test)</intervention_name>
    <description>The adrenergic stress reaction is recorded by a saliva test.</description>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_label>Mothers / children after diabetes in pregnancy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study collective is composed of mother-child pairs after gestational diabetes, which&#xD;
        were supervised in the Competence Center for Diabetes and Pregnancy at the University&#xD;
        Hospital of Jena. The patients can decide to fill in an online questionnaire. For all other&#xD;
        parts of the study, only patients who have been informed independently or on behalf of&#xD;
        their legal guardian about the nature of the study after a detailed and understandable&#xD;
        explanatory discussion with an investigator and who have given written consent will be&#xD;
        included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For the pilot project: Initial participation in the preliminary study&#xD;
&#xD;
          -  Written Informed Consent&#xD;
&#xD;
          -  Singleton pregnancies&#xD;
&#xD;
          -  Delivery at the University Hospital Jena&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Severe physical and mental illness&#xD;
&#xD;
          -  Patients who refuse to participate in the study or drop out&#xD;
&#xD;
          -  Premature birth, i.e. birth of the child &lt;37/0 weeks of gestation&#xD;
&#xD;
          -  Serious pregnancy complications&#xD;
&#xD;
          -  Prenatally known serious malformations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Friederike Weschenfelder, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik für Geburtsmedizin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <state>Thüringen</state>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>April 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adrenergic Agents</mesh_term>
  </intervention_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/NCT04417452
org study id: 2019-1403
nct id: NCT04417452
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objectives of the proposed project are to assess the long-term effects of
      prenatal exposure to gestational diabetes or diabetes on the maturation and health of the
      offspring. In addition, the long-term changes on the health of the affected mothers will be
      investigated, taking into account the metabolic adjustment during index pregnancy. The
      expected results will help to establish possible prevention strategies to fight the epidemic
      of non-communicable diseases for the offspring and the mothers.
Investigation of the long-term outcome of mother-child pairs after diabetic pregnancies and a
      comparison group regarding metabolic, cardiovascular, neurocognitive and reproductive
      long-term changes as a function of the course of pregnancy and metabolic control
observational model: Cohort
time perspective: Prospective
measure: Metabolic health
time frame: 1 day examination at the study centre
description: effects on metabolic health such as glucose tolerance disorders and diabetes mellitus, obesity and metabolic syndrome (mothers and children)
measure: Neurocognitive development
time frame: 1 day examination at the study centre
description: effects on neurocognitive development, mental health and adrenal and autonomic stress reactivity (mothers and children)
measure: Cardiovascular and vascular health
time frame: 1 day examination at the study centre
description: effects on cardiovascular and vascular health of blood pressure regulation and endothelial function (mothers and children)
measure: Maturation of the gonadal regulation
time frame: 1 day examination at the study centre
description: maturation of gonadal regulation, pubertal development and reproductive health (children)
arm group label: Mothers / children after diabetes in pregnancy
description: The study collective is composed of mother-child pairs after gestational diabetes, which were supervised in the Competence Center for Diabetes and Pregnancy at the University Hospital of Jena. The patients can decide to fill in an online questionnaire. For all other parts of the study, only patients who have been informed individually or on behalf of their legal guardian about the nature of the study after a detailed and understandable explanatory discussion with an investigator and who have given written consent will be included in the study.
arm group label: Controls
description: The control collective is composed of mother-child pairs who were cared for at the same time as the study collective at the University Hospital Jena. This collective is status post singleton pregnancy and term birth. The patients can decide to fill in an online questionnaire. For all other parts of the study, only patients who have been informed individually or on behalf of their legal guardian about the nature of the study after a detailed and understandable explanatory discussion with an investigator and who have given written consent will be included in the study.
intervention type: Other
intervention name: Basic data collection (online survey or written form)
description: Basic data collection is carried out by means of a questionnaire that participants can fill in outside the study centre. It contains questions about the current life situation, sleep and activity behaviour.
arm group label: Controls
arm group label: Mothers / children after diabetes in pregnancy
intervention type: Other
intervention name: Physical examination
description: The physical examination takes place at the study centre and includes the measurement of height, current weight and body fat, as well as the recording of heart and circulation parameters (e.g. blood pressure measurement or determination of vascular health by means of ultrasound). General metabolic and hormonal parameters are analysed by means of a blood sample. In addition, a sugar test for diabetes diagnosis will be carried out.
arm group label: Controls
arm group label: Mothers / children after diabetes in pregnancy
intervention type: Behavioral
intervention name: Psychometric examination
description: Psychometric examination is carried out at the study centre with the help of a RIAS (Reynolds Intellectual Assessment Scales and Screening) test.
arm group label: Controls
arm group label: Mothers / children after diabetes in pregnancy
intervention type: Diagnostic Test
intervention name: Recording of the adrenergic stress reaction (saliva test)
description: The adrenergic stress reaction is recorded by a saliva test.
arm group label: Controls
arm group label: Mothers / children after diabetes in pregnancy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Friederike Weschenfelder, Dr. med.
role: Principal Investigator
affiliation: Klinik für Geburtsmedizin
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus
mesh term: Adrenergic Agents
sharing ipd: No