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Status unknownNCT03269084DIPPUpdated Apr 7, 2023

Type 1 Diabetes Prediction and Prevention (DIPP) Study

An observational study in Type 1 Diabetes Mellitus, sponsored by Riitta Veijola. Status unknown at 3 sites in Finland. Per ClinicalTrials.gov, last updated 2023-04-07.

Sponsored by Riitta Veijola · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
17,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 1 Diabetes Mellitus
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  • Newborn babies with HLA-conferred genetic susceptibility to type 1 diabetes born in three University Hospitals in Finland

Exclusion criteria

Exclusion Criteria:

  • Newborn babies without HLA-conferred genetic susceptibility to type 1 diabetes
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
17,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Children at HLA-conferred risk for T1D

    Other: No intervention. DIPP is an observational study.

Interventions

  • OtherNo intervention. DIPP is an observational study.
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What researchers measure

Primary outcomes

  1. Positivity for at least one islet autoantibody

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

    Time frame: December 31, 2021

  2. Clinical diagnosis of type 1 diabetes

    Hyperglycemia as defined by WHO

    Time frame: December 31, 2021

06

Study locations

3 of 3 sites recruiting
  • University of Oulu and Oulu University Hospital
    Oulu, 90029, Finland
    • Riitta Veijola, MD · Contact · riitta.veijola@oulu.fi · +358 8 3155129
    • Riitta Veijola, MD · Principal investigator
    Recruiting
  • University of Tampere and Tampere University Hospital
    Tampere, 33520, Finland
    Recruiting
  • University of Turku and Turku University Hospital
    Turku, 20520, Finland
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03269084
Lead sponsor
Riitta Veijola
Collaborators
Oulu University Hospital, University of Turku, Turku University Hospital, Tampere University, Tampere University Hospital, Juvenile Diabetes Research Foundation, The Leona M. and Harry B. Helmsley Charitable Trust
Responsible party
Riitta Veijola (Professor of Pediatrics, University of Oulu) — Sponsor-investigator
First posted
Aug 31, 2017
Start date
Nov 7, 1994
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Apr 7, 2023

Study contacts

Riitta Veijola, MD PhD
Contact
riitta.veijola@oulu.fi
+358407422328
Riitta Veijola, MD PhD
principal investigator · University of Oulu, Oulu University Hospital
Mikael Knip, MD PhD
principal investigator · University of Helsinki, Tampere University Hospital
Jorma Toppari, MD PhD
principal investigator · University of Turku, Turku University Hospital
Kalle Kurppa, MD PhD
principal investigator · Tampere University
Heikki Hyöty, MD PhD
principal investigator · Tampere University
Johanna Lempainen, MD PhD
principal investigator · University of Turku

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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