RecruitingOBSERVATIONAL

Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA

This important study aims to understand how a mother's metabolism during pregnancy, particularly if she has gestational diabetes, might influence her baby's developing genes. Researchers believe that certain ‘marks’ on our genes, called epigenetic changes, can be passed from parents to children and affect their health. By studying blood samples from both parents, and looking at the baby's DNA found in the mother’s blood, scientists hope to uncover these links. The goal is to identify early signs of gestational diabetes and better understand how it might affect the baby down the line. This research could lead to new ways of predicting or managing gestational diabetes, making pregnancy safer for mothers and babies.

At a glance

Status

Recruiting

Sponsor

University of Ulm

Enrolment target

Start

30 Mar 2026

Estimated completion

01 Jul 2028

Gestational Diabetes Mellitus (GDM)

What is this study about?

This research project is looking into how a mother's health during pregnancy, especially her metabolism—how her body uses food for energy—can affect her baby. We already know from some studies that the way genes work can be influenced by changes around them, not just in the genes themselves. These changes, called 'epigenetic marks,' can be passed from parents to children and might make them more likely to develop certain health conditions, including gestational diabetes.

The study aims to understand this connection more deeply. Researchers will collect blood samples from both parents. For mothers, they will also do a simple sugar test (oral glucose tolerance test) to check how their body handles sugar. From these samples, they will look at these special 'epigenetic marks' on the DNA. What's clever is that they can find tiny bits of the baby's DNA in the mother's blood, which allows them to study the baby's epigenetic marks without needing to take a sample directly from the baby, making it very safe.

The main goals are to find out if there's a two-way street between the mother's metabolism during pregnancy and her baby's epigenetic marks, and to discover if certain epigenetic marks can act as early warning signs for gestational diabetes. Ultimately, this research could help us better understand why some women develop gestational diabetes and how it might affect their babies, potentially leading to better care in the future.

Key takeaways

Looks at how parents' health before and during pregnancy might affect their baby.
Focuses on gestational diabetes and ‘epigenetic marks’ on DNA.
Uses blood samples from both parents, including baby's DNA from mother's blood.
Aims to find early signs of gestational diabetes and improve future care.
Participation involves blood tests and a sugar tolerance test for the mother.

Who may be eligible?

To join this study, pregnant women need to be between 20 and 28 weeks along (roughly 5 to 7 months pregnant). It’s also important that the baby's father is known and willing to take part as well.

Neither parent should have any serious ongoing health conditions. This includes not having diabetes before pregnancy (Type 1 or Type 2), not taking medicines that affect blood sugar, and not having certain hormone imbalances like an overactive thyroid or PCOS.

Also, the baby shouldn't have shown any known problems in earlier scans or tests. Both parents must be over 18 and understand and sign a consent form to agree to be part of the study.

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.

Are you pregnant and between 20 and 28 weeks?
Is the baby's father known and willing to participate?
Are both you and your partner generally healthy with no major ongoing medical conditions?
Have you not had Type 1 or Type 2 diabetes before this pregnancy?
Are you both over 18 years old?
Are you not regularly taking medications that affect blood sugar levels?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you and your partner will be asked to visit the clinic. During this visit, we will ask you some questions about your health. Blood samples will be taken from both the mother and the father. The mother will also have a standard oral glucose tolerance test, where you drink a sugary drink and have your blood sugar checked over a couple of hours. Researchers will then study the DNA from these blood samples to look at those special 'epigenetic marks'. There are no medications involved in this study, and you won't need follow-up visits specifically for the research after the initial assessment. The total duration of your active participation will involve these assessments on a single day.

Potential risks and benefits

Taking part in this study may offer some potential benefits by helping researchers learn more about gestational diabetes, which could improve care for future mothers and babies. For you personally, there is no direct medical benefit. As with any blood test, there's a small risk of minor discomfort, bruising, or a mild infection at the site where blood is taken. The oral glucose tolerance test can sometimes cause mild nausea. You are free to withdraw from the study at any time for any reason, without it affecting your medical care.

Locations (1)

Ulm University Hospital
Verified postcode
Ulm, Germany· Recruiting

Common questions

What is gestational diabetes?

Gestational diabetes is a type of diabetes that develops during pregnancy and usually goes away after the baby is born. It means your blood sugar levels are too high.

What are 'epigenetic marks'?

Think of epigenetic marks as tiny switches or dimmers on your genes. They don't change the gene itself, but they can turn genes on or off, or make them work harder or softer, which can affect your health.

Will this study tell me if I have a health problem?

The study aims to understand general patterns, not to diagnose individuals. However, if the researchers find anything unusual that doctors think you should know about, they will let you know.

Is it safe for my baby?

Yes, it is very safe. Researchers collect the baby's DNA from the mother's blood, so no samples are taken directly from the baby.

How long will my involvement in the study last?

Your direct involvement, including all tests and samples, will take place on a single day.

How to find out more

Martin Heni, Prof, MD

martin.heni@uniklinik-ulm.de +49 731 500 44505 Official trial record

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