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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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Trial website
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
mitytykes@sunnybrook.ca
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.