Examining the effects of metformin exposure during pregnancy on children aged 5-11
A Multi-centre Follow up Study of the Effect of In-utero Exposure to Metformin in 5-11 Year Old Offspring of Mothers in the MiTy Trial
This study is trying to see how being exposed to the diabetes drug metformin during pregnancy affects the growth and health of children aged 5 to 11.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Sex | All |
| Sponsor | Mount Sinai Hospital, Canada Academic / other |
| Locations | 12 sites (Campbelltown, New South Wales and 11 other locations) |
| Trial ID | NCT05025852 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the long-term effects of in-utero exposure to metformin on children aged 5 to 11 years whose mothers participated in the MiTy trial. It aims to understand how metformin, commonly used for managing type 2 diabetes during pregnancy, may influence child development, obesity rates, and overall health outcomes. The study will follow up on these children to assess their growth patterns and health status, particularly focusing on any potential risks or benefits associated with metformin exposure in utero.
Who should consider this trial
Good fit: Ideal candidates for this study are liveborn children aged 5-11 years whose mothers participated in the MiTy trial and were treated with metformin during pregnancy.
Not a fit: Children with major congenital anomalies that affect growth or development will not benefit from this study as they have already been excluded from the MiTy Kids follow-up.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term health implications of metformin exposure during pregnancy, potentially guiding treatment decisions for diabetic mothers.
How similar studies have performed: Previous studies have indicated potential links between metformin exposure during pregnancy and increased childhood obesity, suggesting that this area of research is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Liveborn offspring of women who participated in the MiTy trial. Exclusion Criteria: * Offspring with major congenital anomalies that would affect growth or development (these children have already been excluded from MiTy Kids).
Where this trial is running
Campbelltown, New South Wales and 11 other locations
- Campbelltown Hospital — Campbelltown, New South Wales, Australia (Recruiting)
- Mater Misericordiae — Brisbane, Queensland, Australia (Recruiting)
- Alberta Children's Hospital — Calgary, Alberta, Canada (Recruiting)
- Stollery Children's Hospital — Edmonton, Alberta, Canada (Recruiting)
- British Columbia Children's Hospital — Vancouver, British Columbia, Canada (Completed)
- Children's Health Research Institute of Manitoba (CHRIM) — Winnipeg, Manitoba, Canada (Completed)
- IWK Health Centre — Halifax, Nova Scotia, Canada (Completed)
- St Joseph's Health Care — London, Ontario, Canada (Recruiting)
- The Scarborough Hospital — Scarborough Village, Ontario, Canada (Recruiting)
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
- Hospital Maisonneuve-Rosemont — Montreal, Quebec, Canada (Recruiting)
- Chuq-Chul — Québec, Quebec, Canada (Completed)
Study contacts
- Principal investigator: Denice Feig, MD — Mount Sinai Hospital, Toronto, ON, Canada
- Study coordinator: Siobhan Tobin, HonBSc
- Email: mitytykes@sunnybrook.ca
- Phone: 416-480-5631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.