2022-501693-19-00CompletedPhase 4
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Nov 2024
Brief summary (registry, in English)
The primary trial objective is to determine the concentration of metformin in plasma of breast fed infants of lactating women treated for Type 2 Diabetes.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 19 Oct 2023
- Start date
- 6 Mar 2024
- Lead sponsor
- Uppsala Universitet
- Diseases
- Type 2 diabetes
- EU CT number
- 2022-501693-19-00
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 30
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous participation in the study. Women not able to read and communicate in Swedish, Arabic, Persian or Somali. Premature children. Women with multiple births.
Who the study is looking for
- Breastfeeding women treated with metformin for suspected or diagnosed type 2 diabetes mellitus (T2DM). Only women of 18 years of age and older will be asked for participation. Breastfeeding children of women that have consented to participate in the study. The guardians of the child are asked for participation.
Age in the registry: - to 64 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sahlgrenska University Hospital-Vastra Gotalandsregionen | Gothenburg | Sweden | Completed |
| Region Oerebro Laen | Orebro | Sweden | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.