We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03269084
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : April 7, 2023
Sponsor:
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
Information provided by (Responsible Party):
Riitta Veijola, University of Oulu

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Other: No intervention. DIPP is an observational study.

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 17000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Type 1 Diabetes Prediction and Prevention (DIPP) Study
Actual Study Start Date : November 7, 1994
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Children at HLA-conferred risk for T1D Other: No intervention. DIPP is an observational study.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Positivity for at least one islet autoantibody [ Time Frame: December 31, 2021 ]
    ICA, IAA, GADA, IA-2A or ZnT8A

  2. Clinical diagnosis of type 1 diabetes [ Time Frame: December 31, 2021 ]
    Hyperglycemia as defined by WHO


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269084


Contacts
Layout table for location contacts
Contact: Riitta Veijola, MD PhD +358407422328 riitta.veijola@oulu.fi

Locations
Layout table for location information
Finland
University of Oulu and Oulu University Hospital Recruiting
Oulu, Finland, 90029
Contact: Riitta Veijola, MD    +358 8 3155129    riitta.veijola@oulu.fi   
Principal Investigator: Riitta Veijola, MD         
University of Tampere and Tampere University Hospital Recruiting
Tampere, Finland, 33520
Contact: Mikael Knip, MD       mikael.knip@helsinki.fi   
Principal Investigator: Mikael Knip, MD         
University of Turku and Turku University Hospital Recruiting
Turku, Finland, 20520
Contact: Jorma Toppari, MD       jorma.toppari@utu.fi   
Principal Investigator: Jorma Toppari, MD         
Sponsors and Collaborators
Riitta Veijola
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
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Riitta Veijola, Professor of Pediatrics, University of Oulu
ClinicalTrials.gov Identifier: NCT03269084    
Other Study ID Numbers: 1-SRA-2016-342-M-R
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: April 7, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases