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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Offspring of women with type 2 diabetes who participated (or are participating) in the MiTy trial. Exclusion Criteria: Offspring with major congenital anomalies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Metformin<br> | |
| Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adiposity in the offspring | Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps). | 24 months | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, MiTy, Metformin in Women, Type 2 Diabetes Pregnancy