Study on Metformin Transfer into Breast Milk and Infant Plasma in Breastfeeding Women with Type 2 or Gestational Diabetes

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What is this study about?

This clinical trial is focused on studying the transfer of the medication metformin into human breast milk and the blood of breastfeeding children. Metformin is a common medication used to treat type 2 diabetes mellitus and gestational diabetes mellitus, which is a type of diabetes that can occur during pregnancy. The purpose of the study is to understand how much metformin is present in the blood of infants who are breastfed by mothers taking this medication.

During the study, breastfeeding women who are being treated with metformin for their diabetes will participate. The study will involve collecting samples of breast milk and blood from both the mothers and their breastfeeding children. These samples will help researchers measure the amount of metformin that passes into the breast milk and the child’s blood. The study will take place over a period of time, with specific points for collecting samples after the mother takes her dose of metformin.

The information gathered from this study will help provide a better understanding of the safety and effects of using metformin while breastfeeding. This knowledge is important for ensuring the well-being of both mothers and their children who may be exposed to the medication through breast milk. The study is designed to be low-risk and aims to collect valuable data to inform future healthcare decisions.

1 joining the study

Upon joining the study, you will be asked to provide consent for participation. This includes agreeing to the collection of breast milk and blood samples from both you and your breastfeeding child.

2 medication administration

You will continue taking your prescribed medication, metformin, as part of your treatment for type 2 diabetes or gestational diabetes. The medication is taken orally, but specific dosage and frequency will be as per your existing treatment plan.

3 sample collection

Breast milk samples will be collected at specific times: immediately before taking metformin (0 hours) and 3 hours after taking the medication.

Blood samples will be collected from your breastfeeding child 4 hours after you take your dose of metformin to measure the concentration of the medication in their plasma.

Your blood samples will also be collected at 0 hours, 2 hours, and 3 hours after taking metformin to measure the concentration of the medication in your plasma.

4 biobanking

The collected breast milk and blood samples will be stored for future research purposes. This process is known as biobanking.

5 end of participation

Your participation in the study will conclude once all required samples have been collected and analyzed. The estimated end date for the study is December 31, 2025.

Who Can Join the Study?

Women who are currently breastfeeding and are being treated with a medication called metformin for type 2 diabetes.
Women who are at least 18 years old.
The breastfeeding children of these women can also be part of the study.
The guardians of the child must agree for the child to participate in the study.

Who Cannot Join the Study?

Patients who are not women. This study is only for women.
Patients who are not breastfeeding. The study focuses on breastfeeding women.
Patients who do not have Type 2 Diabetes or Gestational Diabetes. These are specific types of diabetes.
Patients who are not within the age range specified for the study. The study has specific age requirements.
Patients who are considered part of a vulnerable population that the study does not include.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Region Oerebro Laen	Orebro	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.11.2023

Trial locations

Investigated drugs:

Metformin

Metformin is a medication commonly used to treat Type 2 Diabetes. It helps control blood sugar levels by improving the way the body handles insulin. In this clinical trial, researchers are studying how much of this medication passes into the breast milk of mothers who are taking it and how much of it is found in the blood of their breastfeeding infants. This information is important to ensure the safety of breastfeeding while using metformin.

Type 2 Diabetes Mellitus – Type 2 diabetes mellitus is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body’s cells do not respond properly to insulin, and a relative lack of insulin production. Over time, high blood sugar levels can lead to various complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The disease often develops gradually and may initially present with symptoms such as increased thirst, frequent urination, and fatigue. As the condition progresses, individuals may experience more severe symptoms and complications. Lifestyle factors, such as diet and physical activity, play a significant role in the development and progression of type 2 diabetes.

Gestational Diabetes Mellitus – Gestational diabetes mellitus is a form of diabetes that occurs during pregnancy. It is characterized by high blood sugar levels that develop during pregnancy and usually disappear after giving birth. The condition arises when the body cannot produce enough insulin to meet the increased needs during pregnancy. Gestational diabetes can lead to complications for both the mother and the baby if not managed properly. It typically develops in the second or third trimester and may not present noticeable symptoms. Monitoring and managing blood sugar levels are crucial to prevent potential complications.

Trial ID:

2022-501693-19-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Metformin Transfer into Breast Milk and Infant Plasma in Breastfeeding Women with Type 2 or Gestational Diabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?