MiTy Kids (Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial)
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.
Type 2 Diabetes
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial (MiTy Kids)|
- Adiposity in the offspring [ Time Frame: 24 months ] [ Designated as safety issue: No ]Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps).
- Sum of skinfolds in the offspring [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]Triceps, subscapular, suprailiac and biceps.
- Central to peripheral adiposity in the offspring [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]Suprailiac to triceps skinfold ratio.
- Weight gain, BMI and weight-for-length percentile change over time in critical early periods and overall in the offspring. [ Time Frame: 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]Weight and length.
- Overweight and obesity in the offspring [ Time Frame: 3, 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]BMI >85th percentile (overweight) and BMI >97th percentile (obesity) for age and gender from World Health Organization (WHO) growth charts.
- Insulin resistance in the offspring [ Time Frame: 24 months ] [ Designated as safety issue: No ]Fasting insulin, fasting insulin-to-glucose ratio, and the Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR).
- adipocytokine profile in the offspring [ Time Frame: 24 months ] [ Designated as safety issue: No ]Adiponectin and leptin.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01832181
|Contact: Adriana Rodriguez-Valentini||416-480-5630||MiTyKids@sunnybrook.ca|
|Contact: Jessica Stortz||416-480-6100 ext 87546||MiTyKids@sunnybrook.ca|
|Dr. Denice Feig||Recruiting|
|Toronto, Ontario, Canada|
|Principal Investigator:||Denice Feig, MD||Mount Sinai Hospital, Toronto, Ontario, Canada|