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

This study, called PREG-Offspring, is investigating the long-term health and development of children whose mothers either had gestational diabetes during pregnancy or did not. Gestational diabetes is a common type of diabetes that can develop during pregnancy, usually detected between 24 and 28 weeks. It's treated with diet changes and sometimes medication to prevent problems like babies being too large or born too early. However, before it's diagnosed and treated, the baby is exposed to higher sugar levels in the womb. This study wants to understand if these early exposures, even with well-managed gestational diabetes, have any effects on children as they grow from age 6 up to adulthood. Researchers will compare children from both groups to learn more about their health and development.

At a glance

Status
Recruiting
Sponsor
University Hospital Tuebingen
Enrolment target
100
Start
15 Jan 2021
Estimated completion
15 Sep 2036

What is this study about?

When a woman is pregnant, she can sometimes develop a type of diabetes called gestational diabetes. This is very common. Doctors usually find this condition between 24 and 28 weeks of pregnancy through a special test. Once found, mothers work with their healthcare team to manage it, often by changing what they eat and, if needed, taking medication. This treatment helps reduce the chances of problems like the baby being born very big or too early.

However, before gestational diabetes is diagnosed and treatment starts, the baby in the womb might be exposed to slightly higher sugar levels than usual. We know that managing gestational diabetes helps prevent immediate problems, but what we don't fully understand are the long-term effects on the child as they grow older.

That's where the PREG-Offspring study comes in. This study aims to carefully look at different parts of development in children whose mothers had gestational diabetes and compare them to children whose mothers did not. By following these children from age 6 all the way into adulthood, researchers hope to learn more about how a mother having gestational diabetes, even when well-controlled, might affect her child's health and development over many years.

Key takeaways

  • This study looks at how gestational diabetes in pregnancy might affect children's long-term health.
  • It compares children whose mothers had gestational diabetes with those whose mothers didn't.
  • The study follows children aged 6 to 17 years old.
  • It aims to understand development and health aspects.
  • Both boys and girls can take part.

Who may be eligible?

To join this study, both the child and their parent (or guardian) need to agree to take part by signing a consent form.

For mothers, it's important that there's clear proof from their pregnancy records that they had a specific test for diabetes (called an oral glucose tolerance test). If they *did* have gestational diabetes, it needs to be clear that it was well-managed throughout the pregnancy until the baby was born.

Children won't be able to join if they have a severe health problem that would make it impossible to do the study tests, or if they have a blood clotting issue that would make it risky to take blood samples.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Is your child between 6 and 17 years old?
  2. Was the mother's pregnancy history regarding diabetes (or lack thereof) recorded?
  3. If the mother had gestational diabetes, was it managed well during pregnancy?
  4. Does your child have any severe health problems that would prevent them from being examined?
  5. Does your child have a bleeding disorder that would make taking a blood sample risky?
Answer every question to see your result.

What does participation involve?

The detailed description of what taking part involves is not provided in the information given. Typically, studies like this might ask children and parents to come for a few visits over several years for check-ups, questionnaires, and perhaps some simple physical tests or blood samples. There is no mention of new medications being given. The study aims to follow children until adulthood, so it's likely to be a long-term study with a number of follow-up points over several years. The exact number of visits, tests, and total duration would be explained in full detail by the study team.

Potential risks and benefits

Potential benefits of taking part include contributing to important research that could improve understanding and care for children born to mothers with gestational diabetes in the future. There are no direct personal benefits mentioned for the participants. Potential risks could include the discomfort of blood samples (if taken) and the time commitment for study visits. You are always free to withdraw from the study at any time, for any reason, without it affecting your or your child's medical care.

Locations (1)

  • University Hospital Tübingen
    Verified postcode
    Tübingen, Germany· Recruiting

Common questions

What is 'gestational diabetes'?

Gestational diabetes is a type of diabetes that can develop during pregnancy, usually disappearing after the baby is born. Your body can't make enough insulin to handle the extra sugar in your blood.

Why are you studying children who are already 6 to 17 years old?

We want to see the long-term effects of gestational diabetes, so we're looking at older children to understand how it might affect their health and development years later.

Will my child have to take any new medicines?

No, this study is about observing and understanding, not testing new medicines. Your child will not be given any experimental medications.

What kind of tests will my child have?

The information provided doesn't give a detailed list of tests. It might include things like physical check-ups, answering questions, or possibly blood samples. The study team will explain everything fully.

Who can join the study?

Children aged 6 to 17 whose mothers either had gestational diabetes or did not, and whose parents agree to them joining. Both boys and girls can take part.

How to find out more

Louise Fritsche, Dr. rer. nat.

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "PREG - Offspring: Investigation of Children From Mothers Wit…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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