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

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT01832181
• Lead Sponsor: Mount Sinai Hospital, Canada

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-15
• Primary Completion: 2021-04
• Study Completion: 2021-05
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-26
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 287

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Dr. Denice Feig; 🇨🇦 Toronto, Ontario, Canada