Clinical trial NCT04722900: PREG - Offspring: Investigation of Children From Mothers With and Without Gestational Diabetes
Official title: PREG-Offspring: Untersuchung Von Kindern Von Teilnehmerinnen Der Deutschen Studie Gestationsdiabetes (PREG-Studie)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Offspring Exposed to GDM and Control
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants are children from mothers that are enrolled in the PREG study.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body height
timeFrame: Change in body height from birth to age 6, 10, 14 and 17
Secondary outcomes:
measure: Body weight
timeFrame: Change in body weight from birth to age 6, 10, 14 and 17
measure: Body fat
timeFrame: Change of body fat from age 6 to age 10, 14 and 17
measure: Blood pressure
timeFrame: Change of blood pressure from age 6 to age 10, 14 and 17
measure: Pubertal development scale
timeFrame: Change of pubertal development scale from age 6 to age 10, 14 and 17
measure: Blood glucose
timeFrame: Change of blood glucose from age 6 to age 10, 14 and 17
measure: HbA1C
timeFrame: Change of HbA1C from age 6 to age 10, 14 and 17
measure: Cardiometabolic risk markers
timeFrame: Change of cardiometabolic risk markers from age 6 to 10, 14 and 17
measure: Continuous glucose monitoring
timeFrame: Change of blood glucose from age 6 to age 10, 14 and 17
measure: Activity level
timeFrame: Change of activity level from age 6 to 10, 14 and 17
measure: Magnetic resonance imaging
timeFrame: Change of magnetic resonance images from age 6 to 10, 14 and 17
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
Study officials:
affiliation: University Hospital Tübingen
name: Andreas Fritsche
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.