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Diabetes Control and Complications Trial (DCCT)

1. marts 2010 opdateret af: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

1441

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

13 år til 39 år (Barn, Voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Efterforskere

  • Studiestol: Oscar B. Crofford, M.D., Vanderbilt University
  • Studieleder: Carolyn Siebert, M.P.H., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Ledende efterforsker: Patricia A. Cleary, M.S., George Washington University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 1983

Studieafslutning

1. april 1993

Datoer for studieregistrering

Først indsendt

2. august 2006

Først indsendt, der opfyldte QC-kriterier

4. august 2006

Først opslået (Skøn)

7. august 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. marts 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. marts 2010

Sidst verificeret

1. marts 2010

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • N01-DK-6-2204-A (completed)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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