Diabetes Control and Complications Trial (DCCT) - Full Text View

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00360815

Purpose

Background. Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications.

Methods. A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.

Condition	Intervention
Type 1 Diabetes Mellitus	Behavioral: Insulin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Diabetes Control and Complications Trial (DCCT)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment:	1441
Study Start Date:	August 1983
Estimated Study Completion Date:	April 1993

Eligibility

Ages Eligible for Study:	13 Years to 39 Years
Genders Eligible for Study:	Both

Criteria

Eligibility Criteria:

The major criteria for eligibility included insulin dependence, as evidenced by deficient C-peptide secretion; an age of 13 to 39 years; and the absence of hypertension, hypercholesterolemia, and severe diabetic complications or medical conditions. To be eligible for the primary-prevention cohort, patients were required to have had insulin dependent diabetes mellitus (IDDM) for one to five years, to have no retinopathy as detected by seven-field stereoscopic fundus photography, and to have urinary albumin excretion of less than 40 mg per 24 hours. To be eligible for the secondary-intervention cohort, the patients were required to have IDDM for 1 to 15 years, to have very-mild to moderate nonproliferative retinopathy, and to have urinary albumin excretion of less than 200 mg per 24 hours.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360815

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Locations

United States, California
University of California
La Jolla, California, United States, 92093-0620
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Florida
University of South Florida College of Medicine
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
DCCT Central Autonomic Coding Unit
Springfield, Illinois, United States, 62702
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
George Washington University, Biostatistics Center
Rockville, Maryland, United States, 20852
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Joslin Diabetes Center, Inc.
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
University of Michigan, Sattelite-Henry Ford Hospital
Ann Arbor, Michigan, United States, 48109-0832
United States, Minnesota
Mayo Foundation
Rochester, Minnesota, United States, 55905
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
University of Minnesota
Minneapolis, Minnesota, United States, 55455
DCCT Central Biochemistry Laboratory
Minneapolis, Minnesota, United States, 55455-9980
DCCT Central ECG Reading Unit
Minneapolis, Minnesota, United States, 55455-1015
DCCT Central Nutrition Coding Unit
Minneapolis, Minnesota, United States, 55454-1015
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
Washington University at St. Louis
St. Louis, Missouri, United States, 63110
Backup DCCT Central HbA1c Lab
Columbia, Missouri, United States, 65201
United States, New Mexico
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States, 87131
United States, New York
Cornell University Medical College, The New York Hospital
New York, New York, United States, 10021
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
United States, Ohio
Case Western Reserve University, Lakeside Hospital
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pennsylvania, The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh, Children's Hospital
Pittsburgh, Pennsylvania, United States, 15213-3417
DCCT Central Neurobehavioral Coding Unit
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403-5851
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232-2230
University of Tennessee
Memphis, Tennessee, United States, 38163
Vanderbilt University, Diabetes Research and Training Center
Nashville, Tennessee, United States, 37212
United States, Texas
University of Texas
Dallas, Texas, United States, 75235
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
United States, Wisconsin
DCCT Central Ophthalmologic Reading Unit, Fundus Photo Reading Center
Madison, Wisconsin, United States, 53705-0240
Canada, British Columbia
University of Washington (British Columbia Satellite)
Vancouver, British Columbia, Canada, V5Z 3N9
Canada, Ontario
University of Toronto, Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
University of Western Ontario
London, Ontario, Canada, N6A 5A5

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Study Chair:	Oscar B. Crofford, M.D.	Vanderbilt University
Study Director:	Carolyn Siebert, M.P.H.	National Institutes of Health, National Institute of Diabetes, and Digestive and Kidney Diseases
Principal Investigator:	Patricia A. Cleary, M.S.	George Washington University

More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group; Nathan DM, Zinman B, Cleary PA, Backlund JY, Genuth S, Miller R, Orchard TJ. Modern-day clinical course of type 1 diabetes mellitus after 30 years' duration: the diabetes control and complications trial/epidemiology of diabetes interventions and complications and pittsburgh epidemiology of diabetes complications experience (1983-2005). Arch Intern Med. 2009 Jul 27;169(14):1307-16.

White NH, Sun W, Cleary PA, Danis RP, Davis MD, Hainsworth DP, Hubbard LD, Lachin JM, Nathan DM. Prolonged effect of intensive therapy on the risk of retinopathy complications in patients with type 1 diabetes mellitus: 10 years after the Diabetes Control and Complications Trial. Arch Ophthalmol. 2008 Dec;126(12):1707-15.

Study ID Numbers:	N01-DK-6-2204-A
Study First Received:	August 2, 2006
Last Updated:	August 4, 2006
ClinicalTrials.gov Identifier:	NCT00360815 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on November 27, 2009