TrialNet Pathway to Prevention of T1D
Linda DiMeglio, MD
Primary Investigator
Brief description of study
Rationale
The accrual of data from the laboratory and from epidemiologic and prevention trials hasved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, andharacterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. The TrialNetural History Study of the Development of T1DM (Pathway to Prevention Study) has been designed to clarify this picture, and in so doing, will contribute to the development andudies aimed at prevention of and early treatment in T1DM.
Purpose
TrialNet is an international network dedicated to the study, prevention, and early treatmentype 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland,d Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated tog new approaches to the prevention of and early intervention for type 1 diabetes.
The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is tohance our understanding of the demographic, immunologic, and metabolic characteristics ofdividuals at risk for developing type 1 diabetes.
The Natural History Study will screen relatives of people with type 1 diabetes to identifyhose at risk for developing the disease. Relatives of people with type 1 diabetes have about5% percent chance of being positive for the antibodies associated with diabetes. TrialNet will identify adults and children at risk for developing diabetes by testing for the presencehese antibodies in the blood. A positive antibody test is an early indication that damageulin-secreting cells may have begun. If this test is positive, additional testing will be offered to determine the likelihood that a person may develop diabetes. Individuals withbodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the developmentdiabetes.
Detailed description of study
Detailed Description:
The Pathway to Prevention Study is conducted in two parts:
- Screening
- Monitoring (annual and semi-annual depending on risk)
In Screening , a simple blood test is done to screen for the presence of diabetes-related biochemical autoantibodies (GAD and mIAA). Additional autoantibodies ICA, IA-2A, and ZnT8A will also measured in individuals positive for mIAA. ICA, IA-2A, and ZnT8A will be measureddividuals positive for GAD. Participants can go to a TrialNet Clinical Center, Affiliate, or request a screening kit to have their blood drawn by a local physician orboratory. Participants will be provided with their screening results within 4-6 weeks.
If autoantibodies are present, participants will be invited to have additional testing to determine their average risk of developing diabetes over the next 5 years. Participants thatgle autoantibody positive will be re-tested annually for the development of multipleutoantibodies. Multiple autoantibody positive participants will undergo an eligibility visit which will include an Oral Glucose Tolerance Test (OGTT), re-testing for biochemical andutoantibodies if needed, and measurement of HbA1c.
Multiple autoantibody positive individuals with a normal glucose tolerance and an HbA1c < 6.0% will be asked to come for follow-up on annual basis; multiple autoantibody positivedividuals with an abnormal glucose tolerance or an HbA1c ≥ 6.0%will be asked to come forw-up visits on semi-annual basis.
Participants will be monitored for possible progression towards type 1 diabetes and may bed the opportunity to enter into a prevention study such (e.g., Oral Insulin preventionudy) or an early treatment study if they are diagnosed with type 1 diabetes whileg in the Natural History Study.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Diabetes Mellitus, Type 1, Riley
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Age: 30 months - 45 years
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Gender: All
Inclusion Criteria:
- Individuals 2.5 to 45 years old who have an immediate family member with type 1diabetes (such as a child, parent, or sibling)
- Individuals 2.5-20 years old who have an extended family member with type 1 diabetes(such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
- Individuals 2.5-45 years old without a type 1 diabetes proband, who are known to have1 or more islet antibody are eligible for screening if needed to determine eligibilitydelay or prevent disease progression.
Exclusion Criteria:
To be eligible a person must not:
- Have diabetes already
- Have a previous history of being treated with insulin or oral diabetes medications.
- Currently be using systemic immunosuppressive agents (topical and inhaled agents areble)
- Have any known serious diseases
