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

NCT01832181 | Completed

• 1 other identifier: 10-0129-A
• Study Type: observational
• Target: 287
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Diabetes; MiTy; Metformin in Women; Type 2 Diabetes Pregnancy

Outcome Measures

Primary Outcomes (1)

• Adiposity in the offspring

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

  24 months

Secondary Outcomes (6)

• Sum of skinfolds in the offspring

  6, 12 and 24 months

• Central to peripheral adiposity in the offspring

  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.

  3, 6, 12, 18 and 24 months

• Overweight and obesity in the offspring

  3, 6, 12, 18 and 24 months

• Insulin resistance in the offspring

  24 months

Study Arms (2)

Metformin

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Offspring of women with type 2 diabetes who participated (or are participating) in the MiTy trial.

You may not qualify if:

• Offspring with major congenital anomalies.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Sunnybrook Research Institute: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Dr. Denice Feig

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 36746160 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Denice Feig, MD

  Mount Sinai Hospital, Toronto, Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 15, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Locations

CA (1)