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Trial record 1 of 1 for:    NCT00360815
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Diabetes Control and Complications Trial (DCCT)

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ClinicalTrials.gov Identifier: NCT00360815
Recruitment Status : Completed
First Posted : August 7, 2006
Last Update Posted : March 2, 2010
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: Insulin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 1441 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diabetes Control and Complications Trial (DCCT)
Study Start Date : August 1983
Study Completion Date : April 1993

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00360815


Locations
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Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Study Chair: Oscar B. Crofford, M.D. Vanderbilt University
Study Director: Carolyn Siebert, M.P.H. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Patricia A. Cleary, M.S. George Washington University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00360815    
Other Study ID Numbers: N01-DK-6-2204-A (completed)
First Posted: August 7, 2006    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: March 2010
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs