An observational study in Type 2 Diabetes, sponsored by Mount Sinai Hospital, Canada. Completed at 1 site in Canada. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by Mount Sinai Hospital, Canada · Observational
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.
149 studies on the registry are indexed under Pregnancy in Diabetics; 33 are open to participants now.
This study's enrollment of 287 is above the median of 129 across 60 observational studies indexed under Pregnancy in Diabetics.
Browse Pregnancy in Diabetics studies →Mount Sinai Hospital, Canada is the lead sponsor of 157 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Offspring of women with type 2 diabetes who participated in the MiTy trial during pregnancy.
Exclusion Criteria:
Adiposity in the offspring
Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps).
Time frame: 24 months
Sum of skinfolds in the offspring
Triceps, subscapular, suprailiac and biceps.
Time frame: 6, 12 and 24 months
Central to peripheral adiposity in the offspring
Suprailiac to triceps skinfold ratio.
Time frame: 6, 12 and 24 months
Weight gain, BMI and weight-for-length percentile change over time in critical early periods and overall in the offspring.
Weight and length.
Time frame: 3, 6, 12, 18 and 24 months
Overweight and obesity in the offspring
BMI \>85th percentile (overweight) and BMI \>97th percentile (obesity) for age and gender from World Health Organization (WHO) growth charts.
Time frame: 3, 6, 12, 18 and 24 months
Insulin resistance in the offspring
Fasting insulin, fasting insulin-to-glucose ratio, and the Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR).
Time frame: 24 months
adipocytokine profile in the offspring
Adiponectin and leptin.
Time frame: 24 months
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Mount Sinai Hospital, Canada