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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04722900
Enrollment
100
Registered
2021-01-25
Start date
2021-01-15
Completion date
2036-09-15
Last updated
2021-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Offspring Exposed to GDM and Control

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

OTHERintrauterine exposure to elevated glucose levels

intrauterine exposure to elevated glucose levels

Sponsors

University Hospital Tuebingen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Body heightChange in body height from birth to age 6, 10, 14 and 17Body height is measured with a tape measure in centimeter (cm)

Secondary

MeasureTime frameDescription
Body fatChange of body fat from age 6 to age 10, 14 and 17Body fat content is measured with bioimpedance anaylsis in percent (%)
Blood pressureChange of blood pressure from age 6 to age 10, 14 and 17Blood pressure is measured with a blood pressure monitor as systolic and diastolic pressure in millimeter mercury column (mm Hg)
Pubertal development scaleChange of pubertal development scale from age 6 to age 10, 14 and 17Pubertal development scale is assessed according to Tanner stages
Blood glucoseChange of blood glucose from age 6 to age 10, 14 and 17Blood glucose is measured in blood sample in miligram per deciliter (mg/dl)
Body weightChange in body weight from birth to age 6, 10, 14 and 17Body weight is measured with a scale in kilogram (kg)
Cardiometabolic risk markersChange of cardiometabolic risk markers from age 6 to 10, 14 and 17Cholesterol, Low-density Lipoprotein, High-density Lipoprotein, Triglycerides, Lipoprotein(a) are measured in blood sample in mg/dl
Continuous glucose monitoringChange of blood glucose from age 6 to age 10, 14 and 1724h glucose profiles and postprandial glycemic excursions (AUC) will be measured by flash glucose monitoring
Activity levelChange of activity level from age 6 to 10, 14 and 17Activity level is assessed with the MOMO activity questionnaire
Magnetic resonance imagingChange of magnetic resonance images from age 6 to 10, 14 and 17Distribution of whole body fat and visceral and subcutaneous fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3T Whole Body Imager
HbA1CChange of HbA1C from age 6 to age 10, 14 and 17HbA1C is measured in blood sample in percent (%)

Countries

Germany

Contacts

Primary ContactLouise Fritsche, Dr. rer. nat.
louise.fritsche@med.uni-tuebingen.de07071-2980687

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026