- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03269084
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
Conditions
Intervention / 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.
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
- Name: Riitta Veijola, MD PhD
- Phone Number: +358407422328
- Email: riitta.veijola@oulu.fi
Study Locations
-
-
-
Oulu, Finland, 90029
- Recruiting
- University of Oulu and Oulu University Hospital
-
Contact:
- Riitta Veijola, MD
- Phone Number: +358 8 3155129
- Email: riitta.veijola@oulu.fi
-
Principal Investigator:
- Riitta Veijola, MD
-
Tampere, Finland, 33520
- Recruiting
- University of Tampere and Tampere University Hospital
-
Contact:
- Mikael Knip, MD
- Email: mikael.knip@helsinki.fi
-
Principal Investigator:
- Mikael Knip, MD
-
Turku, Finland, 20520
- Recruiting
- University of Turku and Turku University Hospital
-
Contact:
- Jorma Toppari, MD
- Email: jorma.toppari@utu.fi
-
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
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-SRA-2016-342-M-R
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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