Type 1 Diabetes Prediction and Prevention (DIPP) Study

Type 1 Diabetes Mellitus Clinical Trial

— DIPP  

Official title:

Type 1 Diabetes Prediction and Prevention (DIPP) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03269084
• Other study ID #: 1-SRA-2016-342-M-R
• Status: Recruiting
• Start date: November 7, 1994
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: University of Oulu
• Contact: Riitta Veijola, MD PhD
• Phone: +358407422328
• Email: riitta.veijola[@]oulu.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 17000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Other:
• No intervention. DIPP is an observational study.

Locations

Country	Name	City	State
Finland	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

Sponsors (8)

Lead Sponsor	Collaborator
Riitta Veijola	Juvenile Diabetes Research Foundation, Oulu University Hospital, Tampere University, Tampere University Hospital, The Leona M. and Harry B. Helmsley Charitable Trust, Turku University Hospital, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positivity for at least one islet autoantibody	ICA, IAA, GADA, IA-2A or ZnT8A	December 31, 2021
Primary	Clinical diagnosis of type 1 diabetes	Hyperglycemia as defined by WHO	December 31, 2021