PREG - Offspring: Investigation of Children From Mothers With and Without Gestational Diabetes
ID: NCT04722900
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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.
intrauterine exposure to elevated glucose levels
Treatment Arms Description
- 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
- severe malformation that makes an examination impossible
- existent of coagulation disorder with increased risk of bleeding after blood sampling
Primary Outcome Measures
- 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)
View Secondary Outcome Measures (10)
- 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)
- 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 (%)
- 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)
- 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
- 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)
- HbA1C — Time Frame: Change of HbA1C from age 6 to age 10, 14 and 17
HbA1C is measured in blood sample in percent (%)
- 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
- 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
- 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
- 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
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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- Fritsche L, Hummel J, Wagner R, Loffler D, Hartkopf J, Machann J, Hilberath J, Kantartzis K, Jakubowski P, Pauluschke-Frohlich J, Brucker S, Horber S, Haring HU, Roden M, Schurmann A, Solimena M, de Angelis MH, Peter A, Birkenfeld AL, Preissl H, Fritsche A, Heni M. The German Gestational Diabetes Study (PREG), a prospective multicentre cohort study: rationale, methodology and design. BMJ Open. 2022 Feb 15;12(2):e058268. doi: 10.1136/bmjopen-2021-058268.PubMed ↗
View Official Medical/Scientific Title
PREG-Offspring: Untersuchung Von Kindern Von Teilnehmerinnen Der Deutschen Studie Gestationsdiabetes (PREG-Studie)