The Effect of In-utero Exposure to Metformin in 5-11 Year Old Offspring of Mothers in the MiTy Trial
MiTy Tykes
A Multi-centre Follow up Study of the Effect of In-utero Exposure to Metformin in 5-11 Year Old Offspring of Mothers in the MiTy Trial
1 other identifier
observational
220
2 countries
12
Brief Summary
The incidence of diabetes in pregnancy is rising, with rates of 1 in 7 pregnancies globally. Metformin is used for type 2 diabetes (T2DM) outside of pregnancy and is now increasingly prescribed during pregnancy. There are some concerns as metformin crosses the placenta and effects on offspring exposed during pregnancy are unknown. Animal and human evidence indicate that metformin may create an atypical in-utero environment similar to under-nutrition which has been associated with adult obesity. This is supported by studies in children of mothers treated with metformin in other populations where an increase in childhood obesity was found at 4-9 years of age. We now have evidence from the MiTy trial, that offspring of metformin-exposed women with T2DM have less large infants and are less adipose at birth, but are also more likely to be small for gestational age (SGA). These effects could lead to benefit or harm in the long-term. Offspring of MiTy mothers are currently being followed up to 2 years. Given that long-term effects may not be evident until 5 years of age, it is imperative to follow these children longer. Goals/Research Aims:To determine whether in-utero exposure to metformin, in offspring of women with T2DM, is beneficial or harmful in the long-term. Research Questions: 1. In offspring of women with T2DM, how does treatment with metformin during pregnancy affect a) adiposity b) growth over time c) metabolic syndrome d) cognitive and behavioral measures:2. What factors predict altered childhood adiposity and insulin resistance in these offspring? Primary Outcome: Body mass index (BMI) z-score. Secondary Outcomes: 1) other measures of adiposity (i.e. skinfolds, 2) growth over time 3) measures of insulin resistance 4) adipocytokines 5)neurodevelopment Expected Outcomes Given these increasing concerns, this study will inform the best treatment for pregnant mothers with diabetes by studying the long-term outcomes of children exposed to metformin during pregnancy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedStudy Start
First participant enrolled
May 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedJanuary 16, 2024
January 1, 2024
4 years
August 11, 2021
January 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Body Mass Index (BMI) z-score
Using WHO or other appropriate growth charts
5-11 years of age
Secondary Outcomes (14)
Skinfold measurements
5-11 years of age
Sum of skinfold measurements:
5-11 years of age
Triceps skinfolds z-scores
5-11 years of age
Ratio of the central to peripheral skinfold ratio
5-11 years of age
Overweight and obesity status
5-11 years of age
- +9 more secondary outcomes
Study Arms (2)
Metformin exposed in utero
Offspring of mothers who were exposed to metformin during pregnancy in the MiTy trial.
Placebo exposed in utero
Offspring of mothers who were not exposed to metformin during pregnancy in the MiTy trial.
Eligibility Criteria
Offspring of women with type 2 diabetes who participated in the MiTy trial will be recruited for participation.
You may qualify if:
- Liveborn offspring of women who participated in the MiTy trial.
You may not qualify if:
- Offspring with major congenital anomalies that would affect growth or development (these children have already been excluded from MiTy Kids).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mount Sinai Hospital, Canadalead
- Sunnybrook Research Institutecollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (12)
Campbelltown Hospital
Campbelltown, New South Wales, Australia
Mater Misericordiae
Brisbane, Queensland, Australia
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7, Canada
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
Children's Health Research Institute of Manitoba (CHRIM)
Winnipeg, Manitoba, R3E 3P4, Canada
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
St Joseph's Health Care
London, Ontario, N6A 4V2, Canada
The Scarborough Hospital
Scarborough Village, Ontario, M1P 2V5, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Hospital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Chuq-Chul
Québec, Quebec, G1V 4G2, Canada
Biospecimen
A blood sample will be taken to be analyzed for markers of metabolic syndrome.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denice Feig, MD
Mount Sinai Hospital, Toronto, ON, Canada
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2021
First Posted
August 27, 2021
Study Start
May 11, 2022
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
January 16, 2024
Record last verified: 2024-01