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| Name | Class |
|---|---|
| Sunnybrook Research Institute | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | |||
| Control |
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| Measure | Description | Time Frame |
|---|---|---|
| Adiposity in the offspring | Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of skinfolds in the offspring | Triceps, subscapular, suprailiac and biceps. | 6, 12 and 24 months |
| Central to peripheral adiposity in the offspring | Suprailiac to triceps skinfold ratio. |
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Inclusion Criteria:
Exclusion Criteria:
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Offspring of women with type 2 diabetes who participated in the MiTy trial during pregnancy.
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| Name | Affiliation | Role |
|---|---|---|
| Denice Feig, MD | Mount Sinai Hospital, Toronto, Ontario, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Denice Feig | Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36746160 | Derived | Feig DS, Sanchez JJ, Murphy KE, Asztalos E, Zinman B, Simmons D, Haqq AM, Fantus IG, Lipscombe L, Armson A, Barrett J, Donovan L, Karanicolas P, Tobin S, Mangoff K, Klein G, Jiang Y, Tomlinson G, Hamilton J; MiTy Kids Collaborative Group. Outcomes in children of women with type 2 diabetes exposed to metformin versus placebo during pregnancy (MiTy Kids): a 24-month follow-up of the MiTy randomised controlled trial. Lancet Diabetes Endocrinol. 2023 Mar;11(3):191-202. doi: 10.1016/S2213-8587(23)00004-9. Epub 2023 Feb 3. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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. | 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. | 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). | 24 months |
| adipocytokine profile in the offspring | Adiponectin and leptin. | 24 months |