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

Recruiting

• Conditions: Offspring Exposed to GDM and Control
• Interventions: Other: intrauterine exposure to elevated glucose levels

• Registration Number: NCT04722900
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-14
• Study Start: 2021-01-15
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-25
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-26
• Last Update Posted: 2021-09-02
• Primary Completion: 2036-01-15
• Study Completion: 2036-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GDM	intrauterine exposure to elevated glucose levels	-

Primary Outcome Measures

Name	Time	Method
Body height	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

Name	Time	Method
Pubertal development scale	Change of pubertal development scale from age 6 to age 10, 14 and 17	Pubertal development scale is assessed according to Tanner stages
Blood pressure	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)
Activity level	Change of activity level from age 6 to 10, 14 and 17	Activity level is assessed with the MOMO activity questionnaire
Body weight	Change in body weight from birth to age 6, 10, 14 and 17	Body weight is measured with a scale in kilogram (kg)
Body fat	Change of body fat from age 6 to age 10, 14 and 17	Body fat content is measured with bioimpedance anaylsis in percent (%)
Continuous glucose monitoring	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
Blood glucose	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)
HbA1C	Change of HbA1C from age 6 to age 10, 14 and 17	HbA1C is measured in blood sample in percent (%)
Cardiometabolic risk markers	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
Magnetic resonance imaging	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

Trial Locations

Locations (1)

University Hospital Tübingen; 🇩🇪 Tübingen, Germany