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PREG - Offspring: Investigation of Children From Mothers With and Without Gestational Diabetes

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ClinicalTrials.gov Identifier: NCT04722900
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Study Description
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Brief Summary:
Gestational diabetes is the most common complication during pregrancy. With a screening between week 24 and 28 of gestation women with gestational diabetes can be identified and treated. Treatment comprises modification of diet and in some cases taking medication. This treatment lowers undesirable events like macrosomia or premature birth. However, unitl gestational diabetes is diagnosed the fetus is exposed to increased intrauterine glucose levels. The long-term effects of a well-managed gestational diabetes on the development of the offspring is still not well understood. Therefore, the PREG - Offspring study investigates several aspects of development in children from healthy and gestational diabetes mothers until adulthood.

Condition or disease Intervention/treatment
Offspring Exposed to GDM and Control Other: intrauterine exposure to elevated glucose levels

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PREG-Offspring: Untersuchung Von Kindern Von Teilnehmerinnen Der Deutschen Studie Gestationsdiabetes (PREG-Studie)
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : January 15, 2036
Estimated Study Completion Date : September 15, 2036

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
non-GDM
GDM Other: intrauterine exposure to elevated glucose levels
intrauterine exposure to elevated glucose levels


Outcome Measures
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Primary Outcome Measures :
  1. Body height [ Time Frame: Change in body height from birth to age 6, 10, 14 and 17 ]
    Body height is measured with a tape measure in centimeter (cm)


Secondary Outcome Measures :
  1. Body weight [ Time Frame: Change in body weight from birth to age 6, 10, 14 and 17 ]
    Body weight is measured with a scale in kilogram (kg)

  2. Body fat [ Time Frame: Change of body fat from age 6 to age 10, 14 and 17 ]
    Body fat content is measured with bioimpedance anaylsis in percent (%)

  3. Blood pressure [ Time Frame: Change of blood pressure from age 6 to age 10, 14 and 17 ]
    Blood pressure is measured with a blood pressure monitor as systolic and diastolic pressure in millimeter mercury column (mm Hg)

  4. Pubertal development scale [ Time Frame: Change of pubertal development scale from age 6 to age 10, 14 and 17 ]
    Pubertal development scale is assessed according to Tanner stages

  5. Blood glucose [ Time Frame: Change of blood glucose from age 6 to age 10, 14 and 17 ]
    Blood glucose is measured in blood sample in miligram per deciliter (mg/dl)

  6. HbA1C [ Time Frame: Change of HbA1C from age 6 to age 10, 14 and 17 ]
    HbA1C is measured in blood sample in percent (%)

  7. Cardiometabolic risk markers [ Time Frame: Change of cardiometabolic risk markers from age 6 to 10, 14 and 17 ]
    Cholesterol, Low-density Lipoprotein, High-density Lipoprotein, Triglycerides, Lipoprotein(a) are measured in blood sample in mg/dl

  8. Continuous glucose monitoring [ Time Frame: Change of blood glucose from age 6 to age 10, 14 and 17 ]
    24h glucose profiles and postprandial glycemic excursions (AUC) will be measured by flash glucose monitoring

  9. Activity level [ Time Frame: Change of activity level from age 6 to 10, 14 and 17 ]
    Activity level is assessed with the MOMO activity questionnaire

  10. Magnetic resonance imaging [ Time Frame: Change of magnetic resonance images from age 6 to 10, 14 and 17 ]
    Distribution of whole body fat and visceral and subcutaneous fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3T Whole Body Imager


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study participants are children from mothers that are enrolled in the PREG study.
Criteria

Inclusion Criteria:

  • signed informed consent provided by child and parent
  • documented oral glucose tolerance test of the mother during pregnancy
  • adequate management of gestational diabetes until birth

Exclusion Criteria:

  • severe malformation that makes an examination impossible
  • existent of coagulation disorder with increased risk of bleeding after blood sampling
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04722900


Contacts
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Contact: Louise Fritsche, Dr. rer. nat. 07071-2980687 louise.fritsche@med.uni-tuebingen.de

Locations
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Germany
University Hospital Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Louise Fritsche         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Andreas Fritsche University Hospital Tübingen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04722900    
Other Study ID Numbers: 617/2020BO1
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No