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

Sponsor

Mount Sinai Hospital, Canada (Other)

Overall Status

Completed

CT.gov ID

NCT01832181

Collaborator

Sunnybrook Research Institute (Other), Canadian Institutes of Health Research (CIHR) (Other)

287

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes

Study Design

Study Type:

Observational

Actual Enrollment :

287 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Apr 1, 2021

Actual Study Completion Date :

May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Metformin
Control

Outcome Measures

Primary Outcome Measures

Adiposity in the offspring [24 months]
Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps).

Secondary Outcome Measures

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.
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.
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.