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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
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
Secondary ID [1] 0 0
CTO 3632
Universal Trial Number (UTN)
Trial acronym
MiTy Tykes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Pregnancy in Diabetic 0 0
Child Obesity 0 0
Child Development 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Body Mass Index (BMI) z-score
Timepoint [1] 0 0
5-11 years of age
Secondary outcome [1] 0 0
Skinfold measurements
Timepoint [1] 0 0
5-11 years of age
Secondary outcome [2] 0 0
Sum of skinfold measurements:
Timepoint [2] 0 0
5-11 years of age
Secondary outcome [3] 0 0
Triceps skinfolds z-scores
Timepoint [3] 0 0
5-11 years of age
Secondary outcome [4] 0 0
Ratio of the central to peripheral skinfold ratio
Timepoint [4] 0 0
5-11 years of age
Secondary outcome [5] 0 0
Overweight and obesity status
Timepoint [5] 0 0
5-11 years of age
Secondary outcome [6] 0 0
Waist circumference
Timepoint [6] 0 0
5-11 years of age
Secondary outcome [7] 0 0
Waist to height ratio
Timepoint [7] 0 0
5-11 years of age
Secondary outcome [8] 0 0
Growth trajectory
Timepoint [8] 0 0
5-11 years of age
Secondary outcome [9] 0 0
Fat mass
Timepoint [9] 0 0
5-11 years of age
Secondary outcome [10] 0 0
Percentage of body fat
Timepoint [10] 0 0
5-11 years of age
Secondary outcome [11] 0 0
Measures of insulin resistance and metabolic syndrome
Timepoint [11] 0 0
5-11 years of age
Secondary outcome [12] 0 0
Neurocognitive development
Timepoint [12] 0 0
5-11 years of age
Secondary outcome [13] 0 0
Neurocognitive development
Timepoint [13] 0 0
5-11 years of age
Secondary outcome [14] 0 0
Neurocognitive development
Timepoint [14] 0 0
5-11 years of age

Eligibility
Key inclusion criteria
* Liveborn offspring of women who participated in the MiTy trial.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Offspring with major congenital anomalies that would affect growth or development (these children have already been excluded from MiTy Kids).

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
Mater Misericordiae - Brisbane
Recruitment postcode(s) [1] 0 0
- Campbelltown
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Manitoba
Country [4] 0 0
Canada
State/province [4] 0 0
Nova Scotia
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Mount Sinai Hospital, Canada
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sunnybrook Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Canadian Institutes of Health Research (CIHR)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05025852
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Denice Feig, MD
Address 0 0
Mount Sinai Hospital, Toronto, ON, Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Siobhan Tobin, HonBSc
Address 0 0
Country 0 0
Phone 0 0
416-480-5631
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05025852