Availability of Data, Serum, and DNA from Subjects in the Diabetes Prevention Trial-Type 1 (DPT-1)

Notice Number: NOT-DK-06-008

Key Dates
Release Date: June 5, 2006

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov)

This is to inform potential applicants of the availability of data and samples from the subjects enrolled in the DPT-1 trial which tested the ability of ingested and injected insulin to delay onset of type 1 diabetes in people at risk.   The Diabetes Prevention Trial - Type 1 Diabetes (DPT-1) was a randomized, controlled trial to determine whether insulin could prevent or delay the onset of diabetes in relatives of patients with diabetes.  The study included two separate trials, one in which relatives with a projected 5-year risk of diabetes of greater than 50% (high risk) were treated with injected insulin; and the second in which relatives with a risk between 26% and 50% (intermediate risk) were treated with oral insulin.  Over 100,000 relatives were screened, 711 were randomized into either trial, and 236 went on to develop diabetes after an average of approximately 4 years.  Neither injected nor oral insulin at the doses used were observed to delay or prevent diabetes, although further studies are needed to test whether oral insulin can delay diabetes in people in the intermediate risk group with high titers of insulin autoantibodies. More information about the DPT-1 trial and its results can be found by following this link: http://www.niddk.nih.gov/patient/dpt_1/dpt_1.htm

Data, DNA, and serum samples are currently held by the NIDDK Central Repository.  Data and renewable DNA samples (whole genome amplified) may be obtained on an ongoing basis after review by the NIDDK Repository Committee.  Review for these renewable resources is to ensure that proposed uses are legitimate and are covered under the informed consent given by trial participants.   Instructions for access to data can be found here: https://www.niddkrepository.org/niddk/jsp/request/instruction.jsp

Instructions for access to the renewable DNA resource can be found here: https://www.niddkrepository.org/niddk/jsp/public/sampleInstruction.jsp

Applications for access to the more limited serum and unamplified DNA samples will be reviewed rigorously for scientific merit.  Applicants should first request a copy of the DPT-1 database.  Using the database, applicants should identify the samples required for their study, and prepare a more detailed request under the guidelines posted at the repository website.  Applications for access will be reviewed 3 times per year, December 1, April 1, and August 1.  Applications should be sent to NIDDK using the forms and instructions available here: https://www.niddkrepository.org/niddk/jsp/public/sampleInstruction.jsp

Inquiries
Inquiries regarding this notice may be directed to:

Lisa Spain, Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd. Rm. 695
Bethesda, MD 20892-5460
Telephone: (301) 451-9871
FAX: (301) 480-2688
E-mail: spainl@niddk.nih.gov


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