Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000311651
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
6/09/2005
Date last updated
6/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Metformin in gestational diabetes: the offspring follow up
Scientific title
Metformin in gestational diabetes: follow up of offspring of mothers treated with insulin compared with metformin
Universal Trial Number (UTN)
Trial acronym
MiG:TOFU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes 399 0
Condition category
Condition code
Metabolic and Endocrine 471 471 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Offspring of women who have been randomised to metformin or insulin in the MiG study are being followed through childhood to assess growth and development.
Intervention code [1] 309 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 533 0
Markers of adiposity in the offspring.
Timepoint [1] 533 0
Measured at 2 years of age currently and will be remeasured through childhood.
Primary outcome [2] 534 0
Markers of insulin sensitivity in the offspring.
Timepoint [2] 534 0
Measured at 2 years of age currently and will be remeasured through childhood.
Secondary outcome [1] 1140 0
Neurodeveopmental
Timepoint [1] 1140 0
Assessment at age 2 years and at intervals through childhood.

Eligibility
Key inclusion criteria
Offspring of women who were randomsied in the metformin in geststional diabetes study
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment outside Australia
Country [1] 153 0
New Zealand
State/province [1] 153 0

Funding & Sponsors
Funding source category [1] 529 0
Government body
Name [1] 529 0
Human Research Council
Country [1] 529 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
HRC
Address
Country
Secondary sponsor category [1] 430 0
None
Name [1] 430 0
None
Address [1] 430 0
Country [1] 430 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1530 0
Auckland
Ethics committee address [1] 1530 0
Ethics committee country [1] 1530 0
New Zealand
Date submitted for ethics approval [1] 1530 0
Approval date [1] 1530 0
Ethics approval number [1] 1530 0

Summary
Brief summary
When women with gestational diabetes were randomsied to insulin or metformin treatment in the MiG study, they were asked to consent to follow up of the offpsring. We are now doing the first follow up at 2 ears including detailed body composition measurements, physcial examination and neurodevelopmental assessment. We plan to continue longterm follow up to see if metformin exposure in utero modifies later risks of obesity and type 2 diabetes
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36190 0
Address 36190 0
Country 36190 0
Phone 36190 0
Fax 36190 0
Email 36190 0
Contact person for public queries
Name 9498 0
Dr Janet Rowan
Address 9498 0
National Women's Health
Private Bag 92024
Auckland 1003
Country 9498 0
New Zealand
Phone 9498 0
+64 9 6389909
Fax 9498 0
+ 64 9 3074918
Email 9498 0
jrowan@internet.co.nz
Contact person for scientific queries
Name 426 0
Dr Janet Rowan
Address 426 0
National Women's Health
Private bag 92024
Auckland 1003
Country 426 0
New Zealand
Phone 426 0
+ 64 9 6389909
Fax 426 0
+64 9 307 4918
Email 426 0
jrowan@internet.co.nz

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseNeurodevelopmental outcome at 2 years in offspring of women randomised to metformin or insulin treatment for gestational diabetes.2016https://dx.doi.org/10.1136/archdischild-2015-309602
EmbaseInsulin for the treatment of women with gestational diabetes.2017https://dx.doi.org/10.1002/14651858.CD012037.pub2
EmbaseMetformin in gestational diabetes: The offspring follow-up (MiG TOFU): Body composition and metabolic outcomes at 7-9 years of age.2018https://dx.doi.org/10.1136/bmjdrc-2017-000456
EmbaseThe use of dextrose/insulin infusions during labour and delivery in women with gestational diabetes mellitus: Is there any point?.2017https://dx.doi.org/10.1111/ajo.12518
EmbaseBlood pressure measurement at two years in offspring of women randomized to a trial of metformin for GDM: Follow up data from the MiG trial.2015https://dx.doi.org/10.1186/s12887-015-0372-1
N.B. These documents automatically identified may not have been verified by the study sponsor.