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Type 1 Diabetes Prediction and Prevention (DIPP) Study

Recruiting
Conditions
Type 1 Diabetes Mellitus
Interventions
Other: No intervention. DIPP is an observational study.
Registration Number
NCT03269084
Lead Sponsor
Riitta Veijola
Brief Summary

The Type 1 Diabetes Prediction and Prevention (DIPP) Study in Finland is a population-based long-term clinical follow-up study established since 1994 in three university hospitals in Finland to understand the pathogenesis of type 1 diabetes (T1D), predict the disease, and find preventive treatment.

Detailed Description

Briefly, cord blood samples are collected and HLA-DR-DQ genotypes are determined from newborn babies. Families with a newborn baby carrying a DR-DQ genotype associated with increased risk for T1D are invited to participate in regular follow-up at the age of 3, 6, 9, 12, 18 and 24 months, and thereafter once a year until the age of 15 years or until T1D is diagnosed. Clinical details including maternal diet during pregnancy and lactation and child's diet starting from the age of 3 months are recorded, blood samples are collected, and serum autoantibodies associated with development of T1D are measured. Children who develop beta-cell specific autoimmunity are followed more intensively with measurements of glucose metabolism parameters such as glycated haemoglobin A1c (HbA1c), oral glucose tolerance tests (OGTT) and intravenous glucose tolerance tests (IVGTT). In the DIPP Study more than 1000 children have developed multiple islet autoantibodies and more than 450 of these have progressed to clinical T1D. It has been estimated that 5% of children in the follow-up will develop T1D and 60% of future T1D cases will be reached by the current screening and follow-up strategy.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
17000
Inclusion Criteria
  • Newborn babies with HLA-conferred genetic susceptibility to type 1 diabetes born in three University Hospitals in Finland
Exclusion Criteria
  • Newborn babies without HLA-conferred genetic susceptibility to type 1 diabetes

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Children at HLA-conferred risk for T1DNo intervention. DIPP is an observational study.-
Primary Outcome Measures
NameTimeMethod
Positivity for at least one islet autoantibodyDecember 31, 2021

ICA, IAA, GADA, IA-2A or ZnT8A

Clinical diagnosis of type 1 diabetesDecember 31, 2021

Hyperglycemia as defined by WHO

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

University of Oulu and Oulu University Hospital

🇫🇮

Oulu, Finland

University of Tampere and Tampere University Hospital

🇫🇮

Tampere, Finland

University of Turku and Turku University Hospital

🇫🇮

Turku, Finland

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