Diabetes Control and Complications Trial (DCCT)

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00360815
First received: August 2, 2006
Last updated: March 1, 2010
Last verified: March 2010

August 2, 2006
March 1, 2010
August 1983
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Complete list of historical versions of study NCT00360815 on ClinicalTrials.gov Archive Site
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Diabetes Control and Complications Trial (DCCT)
Diabetes Control and Complications Trial (DCCT)

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
Behavioral: Insulin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1441
April 1993
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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.
Both
13 Years to 39 Years
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Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00360815
N01-DK-6-2204-A (completed)
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP