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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05025852
Other study ID # CTO 3632
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 11, 2022
Est. completion date May 2026

Study information

Verified date January 2024
Source Mount Sinai Hospital, Canada
Contact Siobhan Tobin, HonBSc
Phone 416-480-5631
Email mitytykes@sunnybrook.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date May 2026
Est. primary completion date May 2026
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Liveborn offspring of women who participated in the MiTy trial. Exclusion Criteria: - Offspring with major congenital anomalies that would affect growth or development (these children have already been excluded from MiTy Kids).

Study Design


Locations

Country Name City State
Australia Mater Misericordiae Brisbane Queensland
Australia Campbelltown Hospital Campbelltown New South Wales
Canada Alberta Children's Hospital Calgary Alberta
Canada Stollery Children's Hospital Edmonton Alberta
Canada IWK Health Centre Halifax Nova Scotia
Canada St Joseph's Health Care London Ontario
Canada Hospital Maisonneuve-Rosemont Montréal Quebec
Canada Chuq-Chul Quebec City Quebec
Canada The Scarborough Hospital Scarborough Ontario
Canada Mount Sinai Hospital Toronto Ontario
Canada British Columbia Children's Hospital Vancouver British Columbia
Canada Children's Health Research Institute of Manitoba (CHRIM) Winnipeg Manitoba

Sponsors (3)

Lead Sponsor Collaborator
Mount Sinai Hospital, Canada Canadian Institutes of Health Research (CIHR), Sunnybrook Research Institute

Countries where clinical trial is conducted

Australia,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Mass Index (BMI) z-score Using WHO or other appropriate growth charts 5-11 years of age
Secondary Skinfold measurements triceps, subscapular and suprailiac skinfold thicknesses 5-11 years of age
Secondary Sum of skinfold measurements: sum of triceps, subscapular and suprailiac skinfold thicknesses 5-11 years of age
Secondary Triceps skinfolds z-scores Using WHO or other appropriate growth charts 5-11 years of age
Secondary Ratio of the central to peripheral skinfold ratio ratio of the central (suprailiac) to peripheral (triceps) skinfold ratio; 5-11 years of age
Secondary Overweight and obesity status Defined using WHO or other appropriate growth charts 5-11 years of age
Secondary Waist circumference Waist circumference measurement 5-11 years of age
Secondary Waist to height ratio Waist and height measurements 5-11 years of age
Secondary Growth trajectory Longitudinal growth outcomes will be assessed using adiposity measurements from the MiTy trial (newborns) and at 3, 6, 12, 18 and 24 months from the MiTy Kids trial, to ages 5-11 years in the MiTy Tykes trial. 5-11 years of age
Secondary Fat mass Using the Tanita SC-240 bioimpedance analyzer (BIA) 5-11 years of age
Secondary Percentage of body fat Using the Tanita SC-240 bioimpedance analyzer (BIA) 5-11 years of age
Secondary Measures of insulin resistance and metabolic syndrome The following measurements combined will contribute to the assessment of insulin resistance and metabolic syndrome: fasting glucose, fasting insulin, fasting insulin-to-glucose ratio, and the HOMA-IR, serum levels of leptin, adiponectin and lipids 5-11 years of age
Secondary Neurocognitive development Attention Deficit Hyperactivity Disorder (ADHD)-5 Rating scale 5-11 years of age
Secondary Neurocognitive development Children's Communication Checklist (CCC-2) 5-11 years of age
Secondary Neurocognitive development Social Responsiveness Scale (SRS-2) 5-11 years of age
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