AVAILABILITY OF BIOLOGIC SAMPLES FROM DIABETIC STUDY POPULATION NIH GUIDE, Volume 26, Number 1, January 10, 1997 P.T. 34 Keywords: Biomed. Research Resources, Other Diabetes National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announces that a portion (1/3) of all stored non-renewable samples (plasma, serum, urine) from subjects enrolled in the Diabetes Control and Complications Trial (DCCT) is available for use by the scientific community to address questions for which these samples may be invaluable. The DCCT was a randomized, controlled clinical trial conducted at 29 centers in the U.S. and Canada. A total of 1,441 patients between the ages of 13 and 39 years with insulin-dependent diabetes for 1-15 years were recruited during 1983 through 1989. Approximately half of these subjects had no retinopathy and half had mild retinopathy. Patients were randomly assigned to conventional or intensive diabetes treatment and followed for a mean of 6.5 years for the appearance and progression of retinopathy and other complications. During the course of the study, blood and urine samples were obtained at baseline and at regular intervals for up to 10 years. Following their analysis, these samples were stored in aliquots at the central laboratory at the University of Minnesota. For each available subject at baseline and yearly intervals thereafter, the NIDDK is prepared to release up to 4.5 ml urine, 1 ml serum, and 1 ml plasma per requestor. The NIDDK will support the costs of aliquotting and distributing these samples from the central laboratory for highly meritorious approved projects. This does not include DNA or lymphocyte samples. Associated clinical and demographic data on patients will be made available from the Biostatistics Center at George Washington University. To request samples from the DCCT, investigators should describe the rationale for the study, the analysis proposed, and specific requirements for the samples and associated data. The request must justify the requirement for these unique and non-renewable samples. That is, the request must state why the research is dependent specifically on the samples from the DCCT and why other sources are insufficient for addressing the research objective. Applicants must also indicate what research funding is available or will be sought to conduct the investigation. Samples will be provided at no cost. If required, investigators will be expected to pay costs associated with data analysis for the retrieval of relevant individual subject data, but not the costs of sample retrieval. Requests will be accepted for two deadlines: February 28, 1997 and July 31, 1997. EVALUATION Requests to utilize samples will be evaluated by a committee organized by the NIDDK to include members of the Epidemiology of Diabetes Interventions and Complications (EDIC) study group, the EDIC Data Coordinating Center, EDIC Central Biochemistry Laboratory, NIDDK staff, and external reviewers. The EDIC study is presently following subjects in the DCCT for macrovascular and microvascular endpoints. Requests will be rated based on the importance of the scientific question being posed, the unique requirement for these samples, the quality and thoroughness of the proposal in outlining the specific hypotheses and methods, and the amount of sample required. Consideration will also be given to the willingness of the investigator to share the samples with other investigators, thereby maximizing the number of investigators using the samples. ACTION Investigators will be advised of committee recommendations in a letter approving or disapproving the release of samples for the proposed investigation. Release of samples will be contingent on documentation that resources are available for the proposed project. If funding for the research project is being sought, samples will be released to the investigator only after funding has been obtained. Approval will be effective for a one year period. Documentation that sufficient funds are available to carry out the work proposed using these samples, and that funds are available to cover any costs associated with patient data retrieval must be provided within one year after approval is received. INQUIRIES Requests are to be directed to: Catherine C. Cowie, Ph.D. IDDM Clinical Trials Program National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 5AN24A Bethesda, MD 20892-6600 Telephone: (301) 594-8804 FAX: (301) 480-3503 Email: cowiec@ep.niddk.nih.gov References o The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. NEJM 1993;329:977-986. o The Diabetes Control and Complications Trial (DCCT): design and methodologic considerations for the feasibility phase. Diabetes 1986;35:530-45. o Diabetes Control and Complications Trial (DCCT): results of feasibility study. Diabetes Care 1987;10:1-19. o Diabetes Control and Complications Trial (DCCT): update. Diabetes Care 1990;13:427-33. o Feasibility of centralized measurements of glycated hemoglobin in the DCCT.: a multicenter study. Clin Chem 1987;33:2267-71. o DCCT protocol. Springfield, VA: Department of Commerce, National Technical Information Service, 1988. (Publication no. 88-116462-AS). o DCCT manual of operations. Springfield, VA: Department of Commerce, National Technical Information Service, 1993. (Publication no. 93-183382.) .
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