NIH GUIDE, Volume 26, Number 1, January 10, 1997


P.T. 34


  Biomed. Research Resources, Other 



National Institute of Diabetes and Digestive and Kidney Diseases




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.




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.




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.




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




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


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.


o  DCCT manual of operations.  Springfield, VA:  Department of

Commerce, National Technical Information Service, 1993.  (Publication

no. 93-183382.)



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