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

Status: Recruiting
Location: See all (12) locations...
Study Type: Observational
SUMMARY

Aims: o 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.

Eligibility
Participation Requirements
Sex: All
View:

• Liveborn offspring of women who participated in the MiTy trial.

Locations
Other Locations
Australia
Mater Misericordiae
RECRUITING
Brisbane
Campbelltown Hospital
RECRUITING
Campbelltown
Canada
Alberta Children's Hospital
RECRUITING
Calgary
Stollery Children's Hospital
RECRUITING
Edmonton
IWK Health Centre
COMPLETED
Halifax
St Joseph's Health Care
RECRUITING
London
Hospital Maisonneuve-Rosemont
RECRUITING
Montreal
Chuq-Chul
COMPLETED
Québec
The Scarborough Hospital
RECRUITING
Scarborough Village
Mount Sinai Hospital
RECRUITING
Toronto
British Columbia Children's Hospital
COMPLETED
Vancouver
Children's Health Research Institute of Manitoba (CHRIM)
COMPLETED
Winnipeg
Contact Information
Primary
Siobhan Tobin, HonBSc
mitytykes@sunnybrook.ca
416-480-5631
Backup
Gail Klein, MSc
gail.klein@sunnybrook.ca
416-480-5632
Time Frame
Start Date: 2022-05-11
Estimated Completion Date: 2026-05
Participants
Target number of participants: 220
Treatments
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.
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR), Sunnybrook Research Institute
Leads: Mount Sinai Hospital, Canada

This content was sourced from clinicaltrials.gov