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Trial record 21 of 2791 for:    Type 1 Diabetes

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

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ClinicalTrials.gov Identifier: NCT03269084
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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

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, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Positivity for at least one islet autoantibody [ Time Frame: December 31, 2017 ]
    ICA, IAA, GADA, IA-2A or ZnT8A

  2. Clinical diagnosis of type 1 diabetes [ Time Frame: December 31, 2017 ]
    Hyperglycemia as defined by WHO


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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

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
Contact: Riitta Veijola, MD PhD +358407422328 riitta.veijola@oulu.fi

Locations
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
University of Tampere
Tampere University Hospital
Juvenile Diabetes Research Foundation
The Leona M. and Harry B. Helmsley Charitable Trust
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: Jorma Ilonen, MD PhD University of Turku
Principal Investigator: Heikki Hyöty, MD PhD University of Tampere
More Information

Responsible Party: Riitta Veijola, Professor of Pediatrics, University of Oulu
ClinicalTrials.gov Identifier: NCT03269084     History of Changes
Other Study ID Numbers: 1-SRA-2016-342-M-R
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases