MiTy Kids (Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01832181|
Recruitment Status : Recruiting
First Posted : April 15, 2013
Last Update Posted : October 16, 2018
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.
|Condition or disease|
|Type 2 Diabetes|
|Study Type :||Observational|
|Estimated Enrollment :||450 participants|
|Official Title:||Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial (MiTy Kids)|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
- Adiposity in the offspring [ Time Frame: 24 months ]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 ]Triceps, subscapular, suprailiac and biceps.
- Central to peripheral adiposity in the offspring [ Time Frame: 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. [ Time Frame: 3, 6, 12, 18 and 24 months ]Weight and length.
- Overweight and obesity in the offspring [ Time Frame: 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.
- Insulin resistance in the offspring [ Time Frame: 24 months ]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 ]Adiponectin and leptin.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832181
|Contact: Siobhan Tobin||416-480-5631||MiTyKids@sunnybrook.ca|
|Contact: Kathryn Mangoff||416-480-5629||MiTyKids@sunnybrook.ca|
|Dr. Denice Feig||Recruiting|
|Toronto, Ontario, Canada|
|Principal Investigator:||Denice Feig, MD||Mount Sinai Hospital, Toronto, Ontario, Canada|