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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01832181
• Other study ID #: 10-0129-A
• Status: Completed
• Start date: April 2013
• Est. completion date: May 2021

Study information

• Verified date: November 2021
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: May 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Pregnancy in Diabetics
• Type 2 Diabetes

Locations

Country	Name	City	State
Canada	Dr. Denice Feig	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Canadian Institutes of Health Research (CIHR), Sunnybrook Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adiposity in the offspring	Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps).	24 months
Secondary	Sum of skinfolds in the offspring	Triceps, subscapular, suprailiac and biceps.	6, 12 and 24 months
Secondary	Central to peripheral adiposity in the offspring	Suprailiac to triceps skinfold ratio.	6, 12 and 24 months
Secondary	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
Secondary	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
Secondary	Insulin resistance in the offspring	Fasting insulin, fasting insulin-to-glucose ratio, and the Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR).	24 months
Secondary	adipocytokine profile in the offspring	Adiponectin and leptin.	24 months