Offspring Exposed to GDM and Control
Conditions
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.
Interventions
intrauterine exposure to elevated glucose levels
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
| 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) |
| 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 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) |
| 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) |
| 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 |
| 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 |
| Activity level | Change of activity level from age 6 to 10, 14 and 17 | Activity level is assessed with the MOMO activity questionnaire |
| 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 |
| HbA1C | Change of HbA1C from age 6 to age 10, 14 and 17 | HbA1C is measured in blood sample in percent (%) |
Countries
Germany