Pathway to Prevention Study
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 1 - 45 |
| Updated: | 9/2/2018 |
| Start Date: | February 2004 |
| End Date: | July 2019 |
| Contact: | TrialNet Central Information Center general info |
| Phone: | 1-800-425-8361 |
Natural History Study of the Development of Type 1 Diabetes
RATIONALE
The accrual of data from the laboratory and from epidemiologic and prevention trials has
improved 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, and
characterization of the early metabolic abnormalities in T1DM is steadily increasing.
However, information regarding the natural history of T1DM remains incomplete. The TrialNet
Natural 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 and
implementation of studies aimed at prevention of and early treatment in T1DM.
Purpose:
TrialNet is an international network dedicated to the study, prevention, and early treatment
of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland,
United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to
testing 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 to
enhance our understanding of the demographic, immunologic, and metabolic characteristics of
individuals at risk for developing type 1 diabetes.
The Natural History Study will screen relatives of people with type 1 diabetes to identify
those at risk for developing the disease. Relatives of people with type 1 diabetes have about
a 5% 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 presence
of these antibodies in the blood. A positive antibody test is an early indication that damage
to insulin-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 with
antibodies 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 development
of diabetes.
The accrual of data from the laboratory and from epidemiologic and prevention trials has
improved 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, and
characterization of the early metabolic abnormalities in T1DM is steadily increasing.
However, information regarding the natural history of T1DM remains incomplete. The TrialNet
Natural 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 and
implementation of studies aimed at prevention of and early treatment in T1DM.
Purpose:
TrialNet is an international network dedicated to the study, prevention, and early treatment
of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland,
United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to
testing 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 to
enhance our understanding of the demographic, immunologic, and metabolic characteristics of
individuals at risk for developing type 1 diabetes.
The Natural History Study will screen relatives of people with type 1 diabetes to identify
those at risk for developing the disease. Relatives of people with type 1 diabetes have about
a 5% 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 presence
of these antibodies in the blood. A positive antibody test is an early indication that damage
to insulin-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 with
antibodies 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 development
of diabetes.
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, IA-2A, mIAA). Islet cell autoantibodies (ICA) and ZnT8A are
also measured in individuals positive for one or more biochemical autoantibodies.
Participants can go to a TrialNet Clinical Center, Affiliate, or request a screening kit to
have their blood drawn by a local physician or laboratory. Participants will be provided with
their screening results within 4-6 weeks.
If autoantibodies are present initially and are confirmed by repeat testing, participants
will be invited to have additional testing in baseline monitoring visit to determine their
average risk of developing diabetes over the next 5 years. The baseline monitoring visit will
include an Oral Glucose Tolerance Test (OGTT), re-testing for biochemical and islet cell
autoantibodies if needed, measurement of HbA1c, and HLA (genetic) typing.
Individuals with less than 3% average risk will be asked to come for follow-up on annual
basis; individuals with greater than average 32% risk will be asked to come for follow-up
visits on semi-annual basis.
Participants will be monitored for possible progression towards type 1 diabetes and may be
offered the opportunity to enter into a prevention study such (e.g., Oral Insulin prevention
study) or an early treatment study if they are diagnosed with type 1 diabetes while
participating in the Natural History Study.
- 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, IA-2A, mIAA). Islet cell autoantibodies (ICA) and ZnT8A are
also measured in individuals positive for one or more biochemical autoantibodies.
Participants can go to a TrialNet Clinical Center, Affiliate, or request a screening kit to
have their blood drawn by a local physician or laboratory. Participants will be provided with
their screening results within 4-6 weeks.
If autoantibodies are present initially and are confirmed by repeat testing, participants
will be invited to have additional testing in baseline monitoring visit to determine their
average risk of developing diabetes over the next 5 years. The baseline monitoring visit will
include an Oral Glucose Tolerance Test (OGTT), re-testing for biochemical and islet cell
autoantibodies if needed, measurement of HbA1c, and HLA (genetic) typing.
Individuals with less than 3% average risk will be asked to come for follow-up on annual
basis; individuals with greater than average 32% risk will be asked to come for follow-up
visits on semi-annual basis.
Participants will be monitored for possible progression towards type 1 diabetes and may be
offered the opportunity to enter into a prevention study such (e.g., Oral Insulin prevention
study) or an early treatment study if they are diagnosed with type 1 diabetes while
participating in the Natural History Study.
Inclusion Criteria:
- Individuals 1 to 45 years old who have an immediate family member with type 1 diabetes
(such as a child, parent, or sibling)
- Individuals 1-20 years old who have an extended family member with type 1 diabetes
(such as a cousin, niece, nephew, aunt, uncle, grandparent, or half-sibling)
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 are
acceptable)
- Have any known serious diseases
We found this trial at
19
sites
333 Cedar St
New Haven, Connecticut 06504
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Kevan Herold, MD
Phone: 203-737-2760
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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5801 South Ellis Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
773.702.1234
Principal Investigator: Louis Philipson, MD
Phone: 773-702-3853
University of Chicago One of the world's premier academic and research institutions, the University of...
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Desmond A Schatz, MD
Phone: 352-294-5759
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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1200 Moursund Street
Houston, Texas 77030
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Maria Redondo, MD
Phone: 832-822-3380
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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2401 Gillham Rd
Kansas City, Missouri 64108
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Wayne Moore, Md, PhD
Phone: 816-960-8942
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Antoinette Moran, MD
Phone: 612-624-2922
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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116th St and Broadway
New York, New York 10027
New York, New York 10027
(212) 854-1754
Principal Investigator: Robin S Goland, MD
Phone: 212-851-5465
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: Dorothy Becker, MD
Phone: 412-692-5210
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Atlanta, Georgia 30322
Principal Investigator: Andrew Muir, MD
Phone: 404-727-0637
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Dallas, Texas 75390
Principal Investigator: Philip Raskin, MD
Phone: 214-648-4717
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Denver, Colorado 80262
Principal Investigator: Andrea Steck, MD
Phone: 303-724-5756
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Indianapolis, Indiana 46202
Principal Investigator: Linda DeMeglio, MD
Phone: 866-230-8486
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Miami, Florida 33136
Principal Investigator: David Baidal, MD
Phone: 305-243-3781
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2201 West End Ave
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: William Russell, MD
Phone: 615-936-8638
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Parkville, Victoria
Principal Investigator: Peter C Colman, MD
Phone: 61-3-9342 7063
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San Francisco, California 94143
Principal Investigator: Stephen Gitelman, MD
Phone: 415-514-3730
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Seattle, Washington 98101
Principal Investigator: Carla Greenbaum, MD
Phone: 206-342-6590
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300 Pasteur Dr
Stanford, California 94305
Stanford, California 94305
(650) 723-4000
Principal Investigator: Darrell Wilson, MD
Phone: 650-498-4450
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Tampa, Florida 33612
Principal Investigator: Henry Rodriguez, MD
Phone: 813-974-2793
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