Why are more children getting Type 1 Diabetes? Exploring the environmental triggers islet autoimmunity and type 1 diabetes

Not Applicable

Active, not recruiting

• Conditions: Type 1 diabetes; Metabolic and Endocrine - Diabetes; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12613000794707
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-16
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 1510

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.

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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).<br><br> 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.[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.]<br>

Secondary Outcome Measures

Name	Time	Method
Development of type 1 diabetes as measured by blood glucose testing and HbA1c analysis.[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.]