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

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Diabetes Control and Complications Trial (DCCT)

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin human

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

Hide Study Locations

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
University of Maryland
Baltimore, Maryland, United States, 21201
George Washington University, Biostatistics Center
Rockville, Maryland, United States, 20852
United States, Massachusetts
Joslin Diabetes Center, Inc.
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan, Sattelite-Henry Ford Hospital
Ann Arbor, Michigan, United States, 48109-0832
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
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 Nutrition Coding Unit
Minneapolis, Minnesota, United States, 55454-1015
DCCT Central ECG Reading Unit
Minneapolis, Minnesota, United States, 55455-1015
Mayo Foundation
Rochester, Minnesota, United States, 55905
United States, Missouri
Backup DCCT Central HbA1c Lab
Columbia, Missouri, United States, 65201
University of Missouri
Columbia, Missouri, United States, 65212
Washington University at St. Louis
St. Louis, Missouri, United States, 63110
United States, New Mexico
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States, 87131
United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Cornell University Medical College, The New York Hospital
New York, New York, United States, 10021
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
University of Tennessee
Memphis, Tennessee, United States, 38163
Vanderbilt University
Nashville, Tennessee, United States, 37232-2230
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 Western Ontario
London, Ontario, Canada, N6A 5A5
University of Toronto, Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5

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 ClinicalTrials.gov Identifier (NCT Number):

Pop-Busui R, Cleary PA, Braffett BH, Martin CL, Herman WH, Low PA, Lima JA, Bluemke DA; DCCT/EDIC Research Group. Association between cardiovascular autonomic neuropathy and left ventricular dysfunction: DCCT/EDIC study (Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications). J Am Coll Cardiol. 2013 Jan 29;61(4):447-54. doi: 10.1016/j.jacc.2012.10.028. Epub 2012 Dec 19.

Purnell JQ, Zinman B, Brunzell JD; DCCT/EDIC Research Group. The effect of excess weight gain with intensive diabetes mellitus treatment on cardiovascular disease risk factors and atherosclerosis in type 1 diabetes mellitus: results from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study (DCCT/EDIC) study. Circulation. 2013 Jan 15;127(2):180-7. doi: 10.1161/CIRCULATIONAHA.111.077487. Epub 2012 Dec 4. PubMed PMID: 23212717.

Kramer JR, Bayless ML, Lorenzi GM, Ziegler GK, Larkin ME, Lackaye ME, Harth J, Diminick LJ, Anderson KL, Braffett BH, Cleary PA; DCCT/EDIC Study Group. Participant characteristics and study features associated with high retention rates in a longitudinal investigation of type 1 diabetes mellitus. Clin Trials. 2012 Dec;9(6):798-805. doi: 10.1177/1740774512458986. Epub 2012 Oct 1.

de Boer IH, Sachs MC, Cleary PA, Hoofnagle AN, Lachin JM, Molitch ME, Steffes MW, Sun W, Zinman B, Brunzell JD; Diabetes Control and Complication Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group. Circulating vitamin D metabolites and kidney disease in type 1 diabetes. J Clin Endocrinol Metab. 2012 Dec;97(12):4780-8. doi: 10.1210/jc.2012-2852. Epub 2012 Sep 18.

Larkin ME, Lorenzi GM, Bayless M, Cleary PA, Barnie A, Golden E, Hitt S, Genuth S. Evolution of the study coordinator role: the 28-year experience in Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC). Clin Trials. 2012 Aug;9(4):418-25. doi: 10.1177/1740774512449532. Epub 2012 Jun 22.

DCCT/EDIC Research Group; de Boer IH, Sun W, Cleary PA, Lachin JM, Molitch ME, Steffes MW, Zinman B. Intensive diabetes therapy and glomerular filtration rate in type 1 diabetes. N Engl J Med. 2011 Dec 22;365(25):2366-76. Epub 2011 Nov 12.

Turkbey EB, Backlund JY, Genuth S, Jain A, Miao C, Cleary PA, Lachin JM, Nathan DM, van der Geest RJ, Soliman EZ, Liu CY, Lima JA, Bluemke DA; DCCT/EDIC Research Group. Myocardial structure, function, and scar in patients with type 1 diabetes mellitus. Circulation. 2011 Oct 18;124(16):1737-46. Epub 2011 Sep 26.

Gai N, Turkbey EB, Nazarian S, van der Geest RJ, Liu CY, Lima JA, Bluemke DA. T1 mapping of the gadolinium-enhanced myocardium: adjustment for factors affecting interpatient comparison. Magn Reson Med. 2011 May;65(5):1407-15. Epub 2010 Dec 16.

Polak JF, Backlund JY, Cleary PA, Harrington AP, O'Leary DH, Lachin JM, Nathan DM; DCCT/EDIC Research Group. Progression of carotid artery intima-media thickness during 12 years in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study. Diabetes. 2011 Feb;60(2):607-13.

Nathan DM, Steffes MW, Sun W, Rynders GP, Lachin JM. Determining stability of stored samples retrospectively: the validation of glycated albumin. Clin Chem. 2011 Feb;57(2):286-90. Epub 2010 Oct 28.

Larkin ME, Backlund JY, Cleary P, Bayless M, Schaefer B, Canady J, Nathan DM; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group. Disparity in management of diabetes and coronary heart disease risk factors by sex in DCCT/EDIC. Diabet Med. 2010 Apr;27(4):451-8.

Younes N, Cleary PA, Steffes MW, de Boer IH, Molitch ME, Rutledge BN, Lachin JM, Dahms W; DCCT/EDIC Research Group. Comparison of urinary albumin-creatinine ratio and albumin excretion rate in the diabetes control and complications trial/epidemiology of diabetes interventions and complications study. Clin J Am Soc Nephrol. 2010 Jul;5(7):1235-42. Epub 2010 May 6.

Molitch ME, Steffes M, Sun W, Rutledge B, Cleary P, de Boer IH, Zinman B, Lachin J; Epidemiology of Diabetes Interventions and Complications Study Group. Development and progression of renal insufficiency with and without albuminuria in adults with type 1 diabetes in the diabetes control and complications trial and the epidemiology of diabetes interventions and complications study. Diabetes Care. 2010 Jul;33(7):1536-43. Epub 2010 Apr 22.

White NH, Sun W, Cleary PA, Tamborlane WV, Danis RP, Hainsworth DP, Davis MD; DCCT-EDIC Research Group. Effect of prior intensive therapy in type 1 diabetes on 10-year progression of retinopathy in the DCCT/EDIC: comparison of adults and adolescents. Diabetes. 2010 May;59(5):1244-53. Epub 2010 Feb 11.

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.

ClinicalTrials.gov Identifier:	NCT00360815 History of Changes
Other Study ID Numbers:	N01-DK-6-2204-A (completed)
Study First Received:	August 2, 2006
Last Updated:	March 1, 2010
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013