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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05025852
Registration number
NCT05025852
Ethics application status
Date submitted
11/08/2021
Date registered
27/08/2021
Date last updated
16/01/2024
Titles & IDs
Public title
The Effect of In-utero Exposure to Metformin in 5-11 Year Old Offspring of Mothers in the MiTy Trial
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Scientific title
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
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Secondary ID [1]
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CTO 3632
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Universal Trial Number (UTN)
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Trial acronym
MiTy Tykes
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2
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Pregnancy in Diabetic
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Child Obesity
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Child Development
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Diet and Nutrition
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Obesity
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Body Mass Index (BMI) z-score
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Assessment method [1]
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Using WHO or other appropriate growth charts
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Timepoint [1]
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5-11 years of age
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Secondary outcome [1]
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Skinfold measurements
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Assessment method [1]
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triceps, subscapular and suprailiac skinfold thicknesses
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Timepoint [1]
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5-11 years of age
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Secondary outcome [2]
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Sum of skinfold measurements:
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Assessment method [2]
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sum of triceps, subscapular and suprailiac skinfold thicknesses
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Timepoint [2]
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5-11 years of age
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Secondary outcome [3]
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Triceps skinfolds z-scores
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Assessment method [3]
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Using WHO or other appropriate growth charts
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Timepoint [3]
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5-11 years of age
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Secondary outcome [4]
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Ratio of the central to peripheral skinfold ratio
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Assessment method [4]
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ratio of the central (suprailiac) to peripheral (triceps) skinfold ratio;
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Timepoint [4]
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5-11 years of age
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Secondary outcome [5]
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Overweight and obesity status
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Assessment method [5]
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Defined using WHO or other appropriate growth charts
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Timepoint [5]
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5-11 years of age
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Secondary outcome [6]
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Waist circumference
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Assessment method [6]
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Waist circumference measurement
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Timepoint [6]
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5-11 years of age
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Secondary outcome [7]
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Waist to height ratio
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Assessment method [7]
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Waist and height measurements
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Timepoint [7]
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5-11 years of age
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Secondary outcome [8]
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Growth trajectory
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Assessment method [8]
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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.
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Timepoint [8]
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5-11 years of age
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Secondary outcome [9]
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Fat mass
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Assessment method [9]
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Using the Tanita SC-240 bioimpedance analyzer (BIA)
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Timepoint [9]
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5-11 years of age
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Secondary outcome [10]
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Percentage of body fat
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Assessment method [10]
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Using the Tanita SC-240 bioimpedance analyzer (BIA)
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Timepoint [10]
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5-11 years of age
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Secondary outcome [11]
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Measures of insulin resistance and metabolic syndrome
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Assessment method [11]
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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
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Timepoint [11]
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5-11 years of age
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Secondary outcome [12]
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Neurocognitive development
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Assessment method [12]
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Attention Deficit Hyperactivity Disorder (ADHD)-5 Rating scale
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Timepoint [12]
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5-11 years of age
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Secondary outcome [13]
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Neurocognitive development
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Assessment method [13]
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Children's Communication Checklist (CCC-2)
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Timepoint [13]
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5-11 years of age
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Secondary outcome [14]
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Neurocognitive development
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Assessment method [14]
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Social Responsiveness Scale (SRS-2)
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Timepoint [14]
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5-11 years of age
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Eligibility
Key inclusion criteria
* Liveborn offspring of women who participated in the MiTy trial.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Offspring with major congenital anomalies that would affect growth or development (these children have already been excluded from MiTy Kids).
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/05/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2026
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Actual
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Sample size
Target
220
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Campbelltown Hospital - Campbelltown
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Recruitment hospital [2]
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Mater Misericordiae - Brisbane
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Recruitment postcode(s) [1]
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- Campbelltown
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Recruitment postcode(s) [2]
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- Brisbane
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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British Columbia
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Country [3]
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Canada
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State/province [3]
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Manitoba
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Country [4]
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Canada
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State/province [4]
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Nova Scotia
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Country [5]
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Canada
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State/province [5]
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Ontario
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Country [6]
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Canada
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State/province [6]
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
Mount Sinai Hospital, Canada
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Sunnybrook Research Institute
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Address [1]
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Country [1]
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Other collaborator category [2]
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Government body
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Name [2]
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Canadian Institutes of Health Research (CIHR)
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05025852
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Denice Feig, MD
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Address
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Mount Sinai Hospital, Toronto, ON, Canada
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Siobhan Tobin, HonBSc
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Address
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Country
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Phone
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416-480-5631
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05025852
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