Natural History Study of the Development of Type 1 Diabetes
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Purpose
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 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, 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 3 to 4 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.
| Condition |
|---|
|
Diabetes Mellitus, Type 1 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Natural History Study of the Development of Type 1 Diabetes |
| Estimated Enrollment: | 75000 |
| Study Start Date: | February 2004 |
| Estimated Study Completion Date: | June 2014 |
The Natural History 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) 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.
Eligibility| Ages Eligible for Study: | 1 Year to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
First and second/third degree relatives of individuals with type 1 diabetes.
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
Contacts and Locations| Contact: TrialNet Central Information Center general info | 1-800-425-8361 |
Hide Study Locations| United States, California | |
| Children's Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Meredith Boch, RN 323-361-6082 mbock@chla.ucla | |
| Principal Investigator: Roshanak Monzani, MD | |
| University of California San Francisco | Recruiting |
| San Francisco, California, United States, 94143-0434 | |
| Contact: David Ng 415-514-3730 csuh@chla.usc.edu | |
| Principal Investigator: Stephen Gitelman, MD | |
| Stanford University Medical Center | Recruiting |
| Stanford, California, United States, 94305-5208 | |
| Contact: Trudy Esrey, RD 650-498-4450 tesrey@stanford.edu | |
| Principal Investigator: Darrell Wilson, MD | |
| United States, Colorado | |
| Barbara Davis Center for Childhood Diabetes | Recruiting |
| Denver, Colorado, United States, 80262 | |
| Contact: Victoria Gage, RN 303-724-6766 victoria.gage@ucdenver.edu | |
| Principal Investigator: H. Peter Chase, MD | |
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06519 | |
| Contact: Laurie Feldman 203-737-2760 laurie.feldman@yale.edu | |
| Contact (203) 737-2511 | |
| Principal Investigator: Kevan Herold, MD | |
| United States, Florida | |
| University of Florida | Recruiting |
| Gainesville, Florida, United States, 32601-0296 | |
| Contact: Roberta Cook, RN 800-749-7424 ext 1 cookr@peds.ufl.edu | |
| Contact: Annie Abraham, RN 352-334-1358 abraa@peds.ufl.edu | |
| Principal Investigator: Desmond A Schatz, MD | |
| University of Miami School of Medicine | Recruiting |
| Miami, Florida, United States, 33101 | |
| Contact: Della Matheson, RN,CDE 305-243-3781 dmatheso@med.miami.edu | |
| Principal Investigator: Jennifer B Marks, MD | |
| University of South Florida Diabetes Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Danielle Henson, RN 813-396-9574 dhenson@health.usf.edu | |
| Principal Investigator: Henry Rodriguez, MD | |
| United States, Indiana | |
| Riley Hospital for Children, Indiana University | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Maria Nicholson 866-230-8486 malnicho@iupui.edu | |
| Principal Investigator: Linda DeMeglio, MD | |
| United States, Massachusetts | |
| Joslin Diabetes Center, Children's Hospital Boston | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Steve Fey 617-732-2400 ext 4147 Stephen.Fay@joslin.harvard.edu | |
| Principal Investigator: Richard Jackson, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 58944 | |
| Contact: Chris Kwong, RN 800-688-5252 ext 42922 kwong001@umn.edu | |
| Principal Investigator: Antoinette Moran, MD | |
| United States, New York | |
| Columbia University | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Ellen Greenberg, MS 212-305-5836 emg25@columbia.edu | |
| Principal Investigator: Robin S Goland, MD | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh of UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Karen Riley, RN 800-242-5836 karen.riley@chp.edu | |
| Principal Investigator: Dorothy Becker, MD | |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States | |
| Contact: Margo Black, RN 615-936-8638 margo.black@vanderbilt.edu | |
| Principal Investigator: William Russell, MD | |
| United States, Texas | |
| University of Texas Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75390-8858 | |
| Contact: Jamie Arthur, RN 214-648-4830 jamie.arthur@utsouthwestern.edu | |
| Principal Investigator: Philip Raskin, MD | |
| United States, Washington | |
| Benaroya Research Institute | Recruiting |
| Seattle, Washington, United States, 98101-2795 | |
| Contact: Mary Ramey 206-223-6842 mramey@benaroyaresearch.ort | |
| Principal Investigator: Carla Greenbaum, MD | |
| Australia, Victoria | |
| Walter and Eliza Hall Institute | Recruiting |
| Parkville, Victoria, Australia, 3050 | |
| Contact: Felicity Healy 61-3-9342 7063 felicity.healy@mh.org.au | |
| Principal Investigator: Peter C Colman, MD | |
| Canada, Ontario | |
| The Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G-1x8 | |
| Contact: Lesley A Eisel, RN 416-813-7654 ext 1798 lesley.eisel@sickkids.ca | |
| Principal Investigator: Diane Wherrett, MD | |
| Finland | |
| University of Turku | Recruiting |
| Turku, Finland, FIN-20520 | |
| Contact: Tuula Simell, MPH,PhD 358-2-313-3427 tuula.simell@utu.fi | |
| Principal Investigator: Olli G Simell, MD,PhD | |
| Italy | |
| Vita-Salute San Raffaele University | Recruiting |
| Milan, Italy, +39-02-2643 2818 | |
| Contact: Pauline Grogan, RN +39-02-2643 2818 grogan.pauline@hsr.it | |
| Principal Investigator: Emanuele Bossi, MD | |
| United Kingdom | |
| University of Bristol | Recruiting |
| Bristol, United Kingdom, BS10 5NB UK | |
| Contact: Claire Lewis, PhD +44-117-959 5337 claire.lewis@bristol.ac.uk | |
| Principal Investigator: Polly Bingley, MD | |
| Study Chair: | Jay S Skyler, M.D. | University of Miami |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00097292 History of Changes |
| Other Study ID Numbers: | NHStudy (IND) |
| Study First Received: | November 19, 2004 |
| Last Updated: | October 22, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
"at risk" for developing type 1 diabetes T1DM T1D |
juvenile diabetes Type 1 Diabetes TrialNet TrialNet |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013