Type 1 Diabetes Prediction and Prevention (DIPP) Study (DIPP)

April 6, 2023 updated by: Riitta Veijola
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.

Study Overview

Status

Recruiting

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.

Study Type

Observational

Enrollment (Anticipated)

17000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Oulu, Finland, 90029
        • Recruiting
        • University of Oulu and Oulu University Hospital
        • Contact:
        • Principal Investigator:
          • Riitta Veijola, MD
      • Tampere, Finland, 33520
        • Recruiting
        • University of Tampere and Tampere University Hospital
        • Contact:
        • Principal Investigator:
          • Mikael Knip, MD
      • Turku, Finland, 20520
        • Recruiting
        • University of Turku and Turku University Hospital
        • Contact:
        • Principal Investigator:
          • Jorma Toppari, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children at HLA-conferred risk for T1D

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Riitta Veijola, MD PhD, University of Oulu, Oulu University Hospital
  • Principal Investigator: Mikael Knip, MD PhD, University of Helsinki, Tampere University Hospital
  • Principal Investigator: Jorma Toppari, MD PhD, University of Turku, Turku University Hospital
  • Principal Investigator: Kalle Kurppa, MD PhD, Tampere University
  • Principal Investigator: Heikki Hyöty, MD PhD, Tampere University
  • Principal Investigator: Johanna Lempainen, MD PhD, University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 1994

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

August 30, 2017

First Submitted That Met QC Criteria

August 30, 2017

First Posted (Actual)

August 31, 2017

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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