Type 2 Diabetes
Conditions
Keywords
Diabetes, MiTy, Metformin in Women, Type 2 Diabetes Pregnancy
Brief 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.
Interventions
None listed
Sponsors
Sunnybrook Research Institute
Canadian Institutes of Health Research (CIHR)
Mount Sinai Hospital, Canada
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adiposity in the offspring | 24 months | Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overweight and obesity in the offspring | 3, 6, 12, 18 and 24 months | BMI \>85th percentile (overweight) and BMI \>97th percentile (obesity) for age and gender from World Health Organization (WHO) growth charts. |
| Sum of skinfolds in the offspring | 6, 12 and 24 months | Triceps, subscapular, suprailiac and biceps. |
| Central to peripheral adiposity in the offspring | 6, 12 and 24 months | 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. | 3, 6, 12, 18 and 24 months | Weight and length. |
| Insulin resistance in the offspring | 24 months | Fasting insulin, fasting insulin-to-glucose ratio, and the Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR). |
| adipocytokine profile in the offspring | 24 months | Adiponectin and leptin. |
Countries
Canada
Outcome results
None listed