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Recruiting NCT04722900

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

— Observational Offspring Exposed to GDM and Control

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intrauterine exposure to elevated glucose levels.
Who it may be relevant to
Registry conditions: Offspring Exposed to GDM and Control. Basic parameters: 6 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other intrauterine exposure to elevated glucose levels
    intrauterine exposure to elevated glucose levels

Primary outcome measures

  • Body height [Time frame: Change in body height from birth to age 6, 10, 14 and 17]
Secondary outcome measures (10)
  • Body weight [Time frame: Change in body weight from birth to age 6, 10, 14 and 17]
  • Body fat [Time frame: Change of body fat from age 6 to age 10, 14 and 17]
  • Blood pressure [Time frame: Change of blood pressure from age 6 to age 10, 14 and 17]
  • Pubertal development scale [Time frame: Change of pubertal development scale from age 6 to age 10, 14 and 17]
  • Blood glucose [Time frame: Change of blood glucose from age 6 to age 10, 14 and 17]
  • HbA1C [Time frame: Change of HbA1C from age 6 to age 10, 14 and 17]
  • Cardiometabolic risk markers [Time frame: Change of cardiometabolic risk markers from age 6 to 10, 14 and 17]
  • Continuous glucose monitoring [Time frame: Change of blood glucose from age 6 to age 10, 14 and 17]
  • Activity level [Time frame: Change of activity level from age 6 to 10, 14 and 17]
  • Magnetic resonance imaging [Time frame: Change of magnetic resonance images from age 6 to 10, 14 and 17]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • University Hospital Tübingen — Tübingen

Publications

  • 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. 202 PMID 35168986

Identifiers

NCT: NCT04722900 · 617/2020BO1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗