Clinical trial NCT03269084: Type 1 Diabetes Prediction and Prevention (DIPP) Study
Official title: Type 1 Diabetes Prediction and Prevention (DIPP) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: University of Turku
name: Turku University Hospital
name: Tampere University
name: Tampere University Hospital
name: Juvenile Diabetes Research Foundation
name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2017-08-31
Enrollment: 17000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Since November 1994 the Finnish Type 1 Diabetes Prediction and Prevention (DIPP) Study has screened 206,707 newborns for HLA-conferred genetic susceptibility for T1D (Figure 1., data as of March 2015). A total of 16,193 children have started clinical follow-up with regular study visits and systematic collection of longitudinal blood and stool samples. Altogether more than 1000 children have seroconverted to positivity for multiple islet autoantibodies (ICA included). A total of 461 children and adolescents have progressed to clinical T1D with DIPP follow-up from birth until diagnosis. Currently there are 7158 children between 3 months and 15 years of age taking part in the DIPP Study follow-up.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Positivity for at least one islet autoantibody
timeFrame: December 31, 2021
measure: Clinical diagnosis of type 1 diabetes
timeFrame: December 31, 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University of Oulu and Oulu University Hospital
city: Tampere
country: Finland
facility: University of Tampere and Tampere University Hospital
city: Turku
country: Finland
facility: University of Turku and Turku University Hospital
Study officials:
affiliation: University of Oulu, Oulu University Hospital
name: Riitta Veijola, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Helsinki, Tampere University Hospital
name: Mikael Knip, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turku, Turku University Hospital
name: Jorma Toppari, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University
name: Kalle Kurppa, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University
name: Heikki Hyöty, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Turku
name: Johanna Lempainen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: