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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

287 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2021-05-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes

Keywords

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Diabetes MiTy Metformin in Women Type 2 Diabetes Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Metformin

No interventions assigned to this group

Control

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denice Feig, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, Toronto, Ontario, Canada

Locations

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Dr. Denice Feig

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Feig DS, Sanchez JJ, Murphy KE, Asztalos E, Zinman B, Simmons D, Haqq AM, Fantus IG, Lipscombe L, Armson A, Barrett J, Donovan L, Karanicolas P, Tobin S, Mangoff K, Klein G, Jiang Y, Tomlinson G, Hamilton J; MiTy Kids Collaborative Group. Outcomes in children of women with type 2 diabetes exposed to metformin versus placebo during pregnancy (MiTy Kids): a 24-month follow-up of the MiTy randomised controlled trial. Lancet Diabetes Endocrinol. 2023 Mar;11(3):191-202. doi: 10.1016/S2213-8587(23)00004-9. Epub 2023 Feb 3.

Reference Type DERIVED

PMID: 36746160 (View on PubMed)

Other Identifiers

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10-0129-A

Identifier Type: -

Identifier Source: org_study_id