Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Transfer of metformin into human breast milk and the plasma of breastfeeding children - A low intervention trial with biobanking of breast milk and plasma in Västra Götalandsregionen and Region Örebro

This study is investigating a medication called metformin, which is used to manage type 2 diabetes and diabetes that can happen during pregnancy (gestational diabetes). The main goal is to understand how much of this medicine gets into a mother's breast milk and then, importantly, how much of it might reach her breastfeeding baby's blood. Researchers will measure the level of metformin in the baby's blood four hours after the mother takes her dose. They will also look at the amount of metformin in the mother's breast milk at different times. This research aims to provide clearer information for mothers and healthcare providers about using metformin safely while breastfeeding.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Uppsala Universitet

Enrolment target

Start

23 Jan 2024

type 2 diabetes mellitus and gestational diabetes mellitus

What is this study about?

This study is about a medicine called metformin, which is used by people with type 2 diabetes or gestational diabetes (diabetes that happens during pregnancy). If you're a mother who takes metformin and also breastfeeds, you might wonder if the medicine could affect your baby. This study aims to answer just that question.

The main thing the researchers want to find out is how much metformin from the mother's medicine dose ends up in her baby's blood. They will specifically check the baby's blood four hours after the mother takes her metformin. They will also measure the amount of metformin in the mother's breast milk at different times to see how the levels change.

Understanding how much metformin passes into breast milk and then, potentially, into a baby's system is really important. It helps doctors and mothers make informed decisions about managing diabetes while breastfeeding, ensuring both the mother's health and the baby's safety. This type of research helps build our knowledge about medicines and breastfeeding, which can be reassuring for many families.

Key takeaways

This study investigates metformin levels in breast milk and babies' blood.
It helps us understand how safe metformin is for breastfeeding mothers.
Only mothers taking metformin for diabetes (type 2 or gestational) can join.
Participation involves providing breast milk and a small baby blood sample.
This research aims to provide clearer guidance for mothers and doctors.

Who may be eligible?

This study is looking for women who are at least 18 years old.

You must be currently breastfeeding and taking metformin for either type 2 diabetes or gestational diabetes. Your doctor will need to confirm these details for you.

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 18 years old or older?
Are you currently breastfeeding?
Are you taking metformin medication?
Is your metformin for type 2 diabetes or gestational diabetes?

Answer every question to see your result.

What does participation involve?

If you choose to take part, you will be asked to provide some breast milk samples at specific times, for example, before you take your metformin dose and a few hours afterwards. Your baby will also need to have a small blood sample taken, usually about four hours after you’ve taken your medication. This is to check the level of metformin in their blood. The research team will explain exactly when and how these samples will be collected. It's a 'low intervention' study, meaning tests are kept to a minimum and there won't be any new medicines given. The total duration of your active participation will likely be just for one day, with follow-up if needed.

Potential risks and benefits

Potential benefits of taking part include contributing to important medical knowledge that can help other breastfeeding mothers with diabetes in the future. You will also receive careful monitoring related to the study. Potential risks are generally low, mainly involving the minor discomfort of blood sampling for both mother and baby. Any specific risks will be fully explained by the research team. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is metformin?

Metformin is a common medication used to help people with type 2 diabetes or gestational diabetes manage their blood sugar levels.

Why is this study being done?

This study aims to understand how much metformin passes from a breastfeeding mother into her baby, to help ensure safe use of the medication while breastfeeding.

Will my baby or I be given new medication as part of the study?

No, this is a 'low intervention' study, meaning you will continue taking your metformin as prescribed by your doctor, and no new medications will be given for the study.

What kind of samples will be needed?

The study will require samples of your breast milk and a small blood sample from your baby.

How long will I need to be involved in the study?

Your active participation, which involves providing samples, will likely take place over one day.