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

Study Overview
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Brief Summary
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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.

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

Conditions
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Offspring Exposed to GDM and Control

Intervention / Treatment
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* Other: intrauterine exposure to elevated glucose levels


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-GDM<br> | |
| GDM<br> | Other: intrauterine exposure to elevated glucose levels<br>* intrauterine exposure to elevated glucose levels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body height | Body height is measured with a tape measure in centimeter (cm) | Change in body height from birth to age 6, 10, 14 and 17 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight | Body weight is measured with a scale in kilogram (kg) | Change in body weight from birth to age 6, 10, 14 and 17 | 
| Body fat | Body fat content is measured with bioimpedance anaylsis in percent (%) | Change of body fat from age 6 to age 10, 14 and 17 | 
| Blood pressure | Blood pressure is measured with a blood pressure monitor as systolic and diastolic pressure in millimeter mercury column (mm Hg) | Change of blood pressure from age 6 to age 10, 14 and 17 | 
| Pubertal development scale | Pubertal development scale is assessed according to Tanner stages | Change of pubertal development scale from age 6 to age 10, 14 and 17 | 
| Blood glucose | Blood glucose is measured in blood sample in miligram per deciliter (mg/dl) | Change of blood glucose from age 6 to age 10, 14 and 17 | 
| HbA1C | HbA1C is measured in blood sample in percent (%) | Change of HbA1C from age 6 to age 10, 14 and 17 | 
| Cardiometabolic risk markers | Cholesterol, Low-density Lipoprotein, High-density Lipoprotein, Triglycerides, Lipoprotein(a) are measured in blood sample in mg/dl | Change of cardiometabolic risk markers from age 6 to 10, 14 and 17 | 
| Continuous glucose monitoring | 24h glucose profiles and postprandial glycemic excursions (AUC) will be measured by flash glucose monitoring | Change of blood glucose from age 6 to age 10, 14 and 17 | 
| Activity level | Activity level is assessed with the MOMO activity questionnaire | Change of activity level from age 6 to 10, 14 and 17 | 
| Magnetic resonance imaging | Distribution of whole body fat and visceral and subcutaneous fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3T Whole Body Imager | Change of magnetic resonance images from age 6 to 10, 14 and 17 |