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Trial registered on ANZCTR
Registration number
ACTRN12613000794707
Ethics application status
Approved
Date submitted
12/07/2013
Date registered
16/07/2013
Date last updated
23/01/2020
Date data sharing statement initially provided
29/01/2019
Date results information initially provided
23/01/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
Why are more children getting Type 1 Diabetes? Exploring the environmental triggers islet autoimmunity and type 1 diabetes
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Scientific title
In children with a first-degree relative with type 1 diabetes, do prenatal and postnatal environmental factors contribute to the development of islet autoimmunity and type 1 diabetes
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Secondary ID [1]
282812
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Nil known
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Universal Trial Number (UTN)
Nil
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Trial acronym
ENDIA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes
289587
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Condition category
Condition code
Metabolic and Endocrine
289923
289923
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0
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Diabetes
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Inflammatory and Immune System
289924
289924
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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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
This is a pregnancy/birth cohort study of children with a first-degree relative with type 1 diabetes. Pregnant mothers and their infants will be followed prospectively from early pregnancy through childhood to investigate relationships between the development of islet autoimmunity (and subsequently type 1 diabetes) and prenatal and postnatal environmental factors. Investigation will involve 3-monthly assessments of the mother during pregnancy, then 3-monthly assessments of the child until 24 months of age and 6-monthly thereafter.
The initial duration of the study is until the child reaches three years of age. We would like to continue to follow these children longer-term into adolescence to determine the relationship between genotype and early environment and the development of islet autoimmunity and type 1 diabetes. Participants will be asked to sign a separate consent form to follow their children from three to ten years of age.
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Intervention code [1]
287496
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Not applicable
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Comparator / control treatment
Not applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Development of antibodies against one or more of the following islet autoantigens detected in serum: glutamic acid decarboxylase 65 (GAD) tyrosine phosphatase-like insulinoma antigen (IA2), insulin, and beta cell-specific zinc transporter 8 (ZnT8).
Insulin autoantibodies will be measured by fluid phase radiobinding assay. ZnT8 autoantibodies will be measured by precipitation of 35S-methionine labelled recombinant human ZnT8 protein. GAD and IA2 autoantibodies will be measured by ELISA.
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Assessment method [1]
289981
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Timepoint [1]
289981
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Islet autoantibodies will be measured 3-monthly from birth until 24 months of age and 6-monthly thereafter up to 3 years of age in the first instance and 10 years of age in the second instance.
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Secondary outcome [1]
303702
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Development of type 1 diabetes as measured by blood glucose testing and HbA1c analysis.
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Assessment method [1]
303702
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Timepoint [1]
303702
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Assessed on a 3-6 monthly basis after the detection of islet autoantibodies up to 3 years of age in the first instance and 10 years of age in the second instance.
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Eligibility
Key inclusion criteria
An unborn child with a first-degree relative with type 1 diabetes, targeting the mother for recruitment during pregnancy from six weeks gestation onwards, or an infant less than six months of age with a first-degree relative with type 1 diabetes. A first-degree relative may be the child's mother, father or sibling.
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Minimum age
No limit
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Maximum age
6
Months
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Incapacity for the pregnant woman, or in the case of postnatal recruitment the child’s primary caregiver, to understand the requirements of her and/or her child’s participation in the study.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
1500 participants will be followed throughout Australia for a median of two years with a 9% rate of persistent islet autoimmunity. Maximum total dropout/lost to follow-up rate is estimated at 15% with the majority of dropouts occurring in the first six months of follow-up. 1200 of the 1500 total study population will be recruited in pregnancy.
For prenatal exposures from 1200 participants, using nQuery Advisor, with 600 participants above the median and 600 below, for a given exposure variable the power is 90% to detect a difference between a survival (i.e. no islet autoimmunity) of 93% in one group and a survival of 88% in the other – with 108 events (islet autoimmunity) or 9% of the total sample of 1200. For examining interactions between uncorrelated exposure variables with approximately 375 participants per combination of above/below the median, the power is 77% to detect a difference in survival (no islet autoimmunity) between 93% and 87% (70 events in 600 participants required).
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
15/02/2013
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Actual
15/02/2013
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Date of last participant enrolment
Anticipated
31/12/2019
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Actual
4/12/2019
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Date of last data collection
Anticipated
1/09/2030
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Actual
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Sample size
Target
1500
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Accrual to date
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Final
1510
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Recruitment hospital [1]
1266
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Womens and Childrens Hospital - North Adelaide
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Recruitment hospital [2]
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment hospital [3]
1270
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Mater Mother's Hospital - South Brisbane
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Recruitment hospital [4]
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The Children's Hospital at Westmead - Westmead
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Recruitment hospital [5]
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Royal Hospital for Women - Randwick
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Recruitment hospital [6]
1274
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St George Hospital - Kogarah
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Recruitment hospital [7]
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [8]
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Barwon Health - Geelong Hospital campus - Geelong
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Recruitment hospital [9]
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Perth Children's Hospital - Nedlands
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Recruitment postcode(s) [1]
7154
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5006 - North Adelaide
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Recruitment postcode(s) [2]
7156
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4101 - South Brisbane
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Recruitment postcode(s) [3]
7157
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2145 - Westmead
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Recruitment postcode(s) [4]
7158
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2031 - Randwick
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Recruitment postcode(s) [5]
7159
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2217 - Kogarah
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Recruitment postcode(s) [6]
21656
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3168 - Clayton
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Recruitment postcode(s) [7]
21657
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3220 - Geelong
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Recruitment postcode(s) [8]
27193
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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Level 1, 16 Marcus Clarke Street, Canberra, ACT 2601
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Country [1]
287594
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Australia
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Funding source category [2]
298784
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Charities/Societies/Foundations
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Name [2]
298784
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JDRF Australia
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Address [2]
298784
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Level 4, 80-84 Chandos St
St Leonards NSW 2065
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Country [2]
298784
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Australia
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Funding source category [3]
298785
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Charities/Societies/Foundations
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Name [3]
298785
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JDRF International
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Address [3]
298785
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26 Broadway, 14th floor
New York, NY 10004
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Country [3]
298785
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United States of America
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Funding source category [4]
298786
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Charities/Societies/Foundations
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Name [4]
298786
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The Leona M. and Harry B. Helmsley Charitable Trust
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Address [4]
298786
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230 Park Avenue, Suite 659
New York, NY 10169
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Country [4]
298786
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United States of America
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Primary sponsor type
University
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Name
University of Adelaide
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Address
Adelaide, SA 5005
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Country
Australia
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Secondary sponsor category [1]
286340
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University
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Name [1]
286340
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University of New South Wales
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Address [1]
286340
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High St, Kensington, NSW 2052
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Country [1]
286340
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Australia
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Secondary sponsor category [2]
286341
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Hospital
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Name [2]
286341
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Melbourne Health
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Address [2]
286341
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The Royal Melbourne Hospital, Parkville, Vic 3050
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Country [2]
286341
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Australia
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Secondary sponsor category [3]
286342
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University
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Name [3]
286342
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University of Western Australia
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Address [3]
286342
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35 Stirling Highway, Crawley, WA 6009
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Country [3]
286342
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Australia
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Secondary sponsor category [4]
286343
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Hospital
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Name [4]
286343
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Mater Health Service
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Address [4]
286343
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Raymond Terrace, South Brisbane, QLD 4101
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Country [4]
286343
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289565
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Women's and Children's Health Network HREC
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Ethics committee address [1]
289565
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Level 2, Samuel Way Building, Women's and Children's Hospital, 72 King William Road, North Adelaide, SA 5006
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Ethics committee country [1]
289565
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Australia
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Date submitted for ethics approval [1]
289565
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Approval date [1]
289565
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10/04/2012
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Ethics approval number [1]
289565
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REC2456 & HREC/16/WCHN/66
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Ethics committee name [2]
289566
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Princess Margaret Hospital for Children HREC
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Ethics committee address [2]
289566
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Roberts Road, Subiaco, WA 6008
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Ethics committee country [2]
289566
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Australia
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Date submitted for ethics approval [2]
289566
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Approval date [2]
289566
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02/07/2012
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Ethics approval number [2]
289566
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1989/EP
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Ethics committee name [3]
289567
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Sydney Children’s Hospital Network HREC
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Ethics committee address [3]
289567
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Locked Bag 4001, Westmead, NSW 2145
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Ethics committee country [3]
289567
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Australia
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Date submitted for ethics approval [3]
289567
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Approval date [3]
289567
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12/03/2013
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Ethics approval number [3]
289567
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12/SCHN/296
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Ethics committee name [4]
289568
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St John of God Health Care HREC
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Ethics committee address [4]
289568
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Level 3, St John of God House, 177-179 Cambridge Street, Wembley, WA 6014
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Ethics committee country [4]
289568
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Australia
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Date submitted for ethics approval [4]
289568
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Approval date [4]
289568
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13/02/2013
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Ethics approval number [4]
289568
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592
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Ethics committee name [5]
289569
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Mater Health Services HREC
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Ethics committee address [5]
289569
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Level 2 Aubigny Place, South Brisbane, Qld 4101
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Ethics committee country [5]
289569
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Australia
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Date submitted for ethics approval [5]
289569
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Approval date [5]
289569
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21/02/2013
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Ethics approval number [5]
289569
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1941C
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Ethics committee name [6]
289570
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Melbourne Health HREC
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Ethics committee address [6]
289570
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Office for Research, Level 6 East, Royal Melbourne Hospital, 300 Grattan Street, Parkville, Vic 3050
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Ethics committee country [6]
289570
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Australia
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Date submitted for ethics approval [6]
289570
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Approval date [6]
289570
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11/04/2013
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Ethics approval number [6]
289570
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2012.147
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Summary
Brief summary
The incidence of type 1 diabetes has increased worldwide, particularly in younger children and those with lower genetic susceptibility. These observations are consistent with environmental effects that promote pancreatic islet autoimmunity and destruction of insulin-producing beta cells. The Environmental Determinants of Islet Autoimmunity (ENDIA) Study is investigating candidate environmental exposures and gene-environment interactions that may contribute to the development of islet autoimmunity and type 1 diabetes.
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Trial website
http://www.endia.org.au
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Trial related presentations / publications
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Public notes
Study Facebook page can be followed at https://www.facebook.com/endiastudy
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Contacts
Principal investigator
Name
41350
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Prof Jennifer Couper
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Address
41350
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Endocrinology and Diabetes Department
Level 2, Clarence Rieger Building
Women's and Children's Hospital
72 King William Road
North Adelaide, 5006
South Australia
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Country
41350
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Australia
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Phone
41350
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+61 8 81616242
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Fax
41350
0
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Email
41350
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jennifer.couper@adelaide.edu.au
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Contact person for public queries
Name
41351
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Dr Megan Penno
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Address
41351
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University Department of Paediatrics
Level 2, Clarence Rieger Building
Women's and Children's Hospital
72 King William Road
North Adelaide, 5006
South Australia
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Country
41351
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Australia
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Phone
41351
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+61 8 81618747
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Fax
41351
0
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Email
41351
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megan.penno@adelaide.edu.au
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Contact person for scientific queries
Name
41352
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Prof Len Harrison
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Address
41352
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Diabetes Laboratory, Molecular Medicine Division
Walter and Eliza Hall Institute of Medical Research
1G Royal Parade
Parkville, 3052
Victoria
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Country
41352
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Australia
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Phone
41352
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+61 3 93452461
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Fax
41352
0
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Email
41352
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harrison@wehi.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Information pertaining to health, lifestyle and environment, and nutrition.
Biological samples including DNA, blood, stool, urine, swabs, placenta tissue, cord tissues, breastmilk, deciduous teeth. In any data sharing arrangement the privacy of the participants will be protected by de-identification and removal of potentially sensitive data elements as required by the HREC.
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When will data be available (start and end dates)?
Start date: 1/1/2018
End date: 1/6/2045 (expected date that the youngest participant will turn 25 years old)
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Available to whom?
Any individual, group or institution may submit a request to access de-identified data and/or biospecimens . In making its resources available to internal or external collaborators, the ENDIA Study Team is bound by its obligations to the Study participants, Human Research Ethics Committees, National Statement of Ethical Conduct in Human Research, institutions, government agencies, key stakeholders.
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Available for what types of analyses?
Analyses may or may not be directly associated with type 1 diabetes.
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How or where can data be obtained?
The defined mechanism for applying for access to ENDIA samples and/or data using the ENDIA Sample/Data Access Concept (ESDAC) system is outlined on the ENDIA website (www.endia.org.au). Biological samples will be provided directly from the central repository in Adelaide. Data will be provided electronically.
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What supporting documents are/will be available?
Study protocol
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How or where can supporting documents be obtained?
Type [1]
1156
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Study protocol
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Citation [1]
1156
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Link [1]
1156
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Email [1]
1156
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Other [1]
1156
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https://bmcpediatr.biomedcentral.com/articles/10.1186/1471-2431-13-124
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Attachment [1]
1156
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Summary results
Have study results been published in a peer-reviewed journal?
No
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Other publications
Have study results been made publicly available in another format?
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Results – basic reporting
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Results – plain English summary
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Download to PDF