NCT01832181

MiTy Kids (Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial)

Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial (MiTy Kids)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 287 (actual)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The prevalence of diabetes in pregnancy is rising in all maternal age groups. There is increasing evidence that in-utero exposure to maternal diabetes is associated with an increased risk of obesity and type 2 diabetes in children and adults. There is an urgent need to reduce these increasing rates of obesity and diabetes in subsequent generations. The MiTy Trial (Metformin in Women with Type 2 Diabetes in Pregnancy Trial) is a CIHR-funded multi-centre, randomized controlled trial of women with type 2 diabetes in pregnancy (sample size n=500). The MiTy Trial is looking to determine the effect of the addition of metformin to a standard regimen of insulin in women with diabetes, on perinatal morbidity and mortality. The MiTy Kids Trial is a follow-up to the MiTy Trial which will determine whether treatment with metformin during pregnancy in women with type 2 diabetes will lead to a reduction in adiposity and improvement in insulin resistance in the offspring of women with diabetes at 2 years of age.

Conditions

• Type 2 Diabetes

Timeline

• Start date: 2013-04-01
• Primary completion: 2021-04-01
• Completion: 2021-05-01
• First posted: 2013-04-15
• Last updated: 2021-11-30

Locations

1 site across 1 country: Canada