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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00360815
First Posted: August 7, 2006
Last Update Posted: March 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Diabetes Control and Complications Trial (DCCT)

Resource links provided by NLM:


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

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
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


  Show 38 Study Locations
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00360815     History of Changes
Other Study ID Numbers: N01-DK-6-2204-A (completed)
First Submitted: August 2, 2006
First Posted: August 7, 2006
Last Update Posted: March 2, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases