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Completed

NCT Number: NCT01832181

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Dr. Denice Feig

Toronto, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Adiposity in the offspring

    Time frame: 24 months

    Anthropometric measures: BMI and sum of skinfolds (triceps, subscapular, suprailiac and biceps).

Secondary outcomes

  1. Sum of skinfolds in the offspring

    Time frame: 6, 12 and 24 months

    Triceps, subscapular, suprailiac and biceps.

  2. Central to peripheral adiposity in the offspring

    Time frame: 6, 12 and 24 months

    Suprailiac to triceps skinfold ratio.

  3. 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.

  4. 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.

  5. 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).

  6. adipocytokine profile in the offspring

    Time frame: 24 months

    Adiponectin and leptin.

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Sunnybrook Research Institute

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Apr 15, 2013
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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