AVAILABILITY OF BIOLOGIC SAMPLES FROM DIABETIC STUDY POPULATION

Release Date:  April 1, 1998

P.T.

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 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.

A short paragraph should 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.  In addition, a short paragraph should
address how the proposed study specifically relates to the scientific objectives
and/or conclusions of the DCCT.  The requestor should address in another
paragraph 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 unique.  For example, the investigator should
consider whether the proposed study can be accomplished just as well with the
annual samples obtained one year 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 June 30, 1998.

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 and how it relates to DCCT scientific objectives, 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

Direct requests to:

Catherine C. Cowie, PhD
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:  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.)

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