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NCT Number: NCT04722900

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

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.

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Key information

Conditions

Offspring Exposed to GDM and Control

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Tübingen

Tübingen, 72076, Germany

Location status: Recruiting

Location contact

Louise Fritsche

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intrauterine exposure to elevated glucose levels

Other

intrauterine exposure to elevated glucose levels

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Louise Fritsche, Dr. rer. nat.

CONTACT

[email protected]

07071-2980687

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

PREG-Offspring: Untersuchung Von Kindern Von Teilnehmerinnen Der Deutschen Studie Gestationsdiabetes (PREG-Studie)

Important dates

Study start
2021
Primary completion
2036
Study completion
2036
First posted
Jan 25, 2021
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.