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

November 26, 2021 updated by: Mount Sinai Hospital, Canada

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

287

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Dr. Denice Feig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Offspring of women with type 2 diabetes who participated in the MiTy trial during pregnancy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control
Metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adiposity in the offspring
Time Frame: 24 months
Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps).
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sum of skinfolds in the offspring
Time Frame: 6, 12 and 24 months
Triceps, subscapular, suprailiac and biceps.
6, 12 and 24 months
Central to peripheral adiposity in the offspring
Time Frame: 6, 12 and 24 months
Suprailiac to triceps skinfold ratio.
6, 12 and 24 months
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.
3, 6, 12, 18 and 24 months
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.
3, 6, 12, 18 and 24 months
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).
24 months
adipocytokine profile in the offspring
Time Frame: 24 months
Adiponectin and leptin.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Sinai Hospital, Canada

Collaborators

Canadian Institutes of Health Research (CIHR)
Sunnybrook Research Institute

Investigators

  • Principal Investigator: Denice Feig, MD, Mount Sinai Hospital, Toronto, Ontario, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

April 1, 2021

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (ESTIMATE)

April 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 26, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-0129-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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