NOT-99-124: AVAILABILITY OF BIOLOGIC SAMPLES FROM DIABETIC STUDY POPULATION

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AVAILABILITY OF BIOLOGIC SAMPLES FROM DIABETIC STUDY POPULATION Release Date: July 13, 1999 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 are uniquely 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. The DCCT demonstrated that intensive treatment reduced the risks of development or progression of retinopathy, nephropathy, and neuropathy by 35-75 percent, depending on the outcome measured. During the course of the study, blood (plasma and serum) and urine samples were obtained at baseline and annually for up to 10 years. The final DCCT sample was obtained at the time of study closeout. These samples were stored frozen at 70 degrees centigrade 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 demographic and clinical data on patients, including retinopathy, nephropathy, and neuropathy status, can be made available from the Biostatistics Center at George Washington University. APPLICATIONS To request samples from the DCCT, investigators must describe the rationale for the study, the analysis proposed, and specific requirements for the samples and associated data. Proposals should be 6-10 pages exclusive of tables, figures, and references. The investigator 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. Proposals to use the DCCT specimens as samples of convenience from patients with type 1 diabetes will not be considered, such as studies necessary for laboratory assay development or validation. In addition, the investigator should address how the proposed study specifically relates to the scientific objectives and/or conclusions of the DCCT. The NIDDK’s primary interest is in studies that will shed light on the mechanisms underlying the observed DCCT treatment effects or novel pathways related to the development of diabetic complications, the occurrence of hypoglycemia, and weight gain, among other DCCT findings. Data on stability of substances to be assayed in the proposed studies should be provided, as well as preliminary animal and human data that support the hypotheses. The requestor should also address what other data from the DCCT database are required in order to test their proposed hypothesis. Specific justification is needed for requesting samples that were drawn at DCCT baseline and at DCCT closeout since these samples are particularly precious and irreplaceable. For example, the investigator should consider whether the proposed study can be accomplished just as well with the annual samples obtained one year after baseline or prior to DCCT closeout. 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. The deadline for requests is December 31, 1999. EVALUATION Requests to utilize samples will be evaluated by a committee organized by the NIDDK to include members of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study group, the DCCT/EDIC Data Coordinating Center, DCCT/EDIC Central Biochemistry Laboratory, NIDDK staff, and external reviewers. The DCCT/EDIC study group is presently following over 90% of the subjects from the DCCT cohort for macrovascular and microvascular endpoints. Requests will be rated based on the importance of the scientific question being posed and how it relates to DCCT and EDIC scientific objectives, the unique requirement for these particular 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. Later requests for additional samples will be reviewed and evaluated on their own merits. Please direct requests to: Catherine C. Cowie, PhD Director, Type 1 Diabetes 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: cc68v@nih.gov References: 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. The Diabetes Control and Complications Trial Research Group. The Diabetes Control and Complications Trial (DCCT): design and methodologic considerations for the feasibility phase. Diabetes 1986,35:530-45. The Diabetes Control and Complications Trial Research Group. Diabetes Control and Complications Trial (DCCT): results of feasibility study. Diabetes Care 1987,10:1-19. The Diabetes Control and Complications Trial Research Group. Diabetes Control and Complications Trial (DCCT): update. Diabetes Care 1990,13:427-33. The Diabetes Control and Complications Trial Research Group. Feasibility of centralized measurements of glycated hemoglobin in the DCCT: a multicenter study. Clin Chem 1987,33:2267-71. The Diabetes Control and Complications Trial Research Group. DCCT data tape archives. Springfield, VA: Department of Commerce, National Technical Information Service, 1996. (Publication no. 96-501895) The Diabetes Control and Complications Trial Research Group. DCCT protocol. Springfield, Va.: Department of Commerce, National Technical Information Service, 1988. (Publication no. 88-116462-AS). The Diabetes Control and Complications Trial Research Group. DCCT manual of operations. Springfield, Va.: Department of Commerce, National Technical Information Service, 1993. (Publication no. 93-183382.) Epidemiology of Diabetes Interventions and Complications (EDIC) Research Group. Epidemiology of Diabetes Interventions and Complications (EDIC): Design, implementation, and preliminary results of a long-term follow-up of the Diabetes Control and Complications Trial cohort. Diabetes Care 1999,22:99-111.

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