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Chicago Childhood Diabetes Registry

4. september 2013 opdateret af: University of Chicago

Population-based Epidemiologic Study of Childhood Diabetes in Chicago: a) Disease Surveillance; b) Family Studies; c) Questionnaire Followup.

The goal of this study is to investigate the epidemiology and natural history of childhood-onset diabetes, whether of autoimmune, non-autoimmune, or mixed etiology in affected probands and their relatives.

Studieoversigt

Detaljeret beskrivelse

The goal of this study is to investigate the epidemiology and natural history of childhood-onset diabetes, whether of autoimmune, non-autoimmune, or mixed etiology in affected probands and their relatives. The following hypotheses frame the research questions to be addressed:

Hypothesis 1. Diabetes as it occurs in youth derives from a spectrum of etiologic processes, from the insulinopenia of autoimmune type 1 to obesity-related, insulin-resistant type 2 diabetes. A subset of children develop diabetes through a combination of the 2 major etiologic pathways, with autoimmune ß-cell destruction aggravated by the presence of insulin resistance related to genetic susceptibility, obesity and/or physical inactivity. A fraction of young patients are unclassifiable at onset due to severe symptomatology and ambiguities in measures of ß-cell function. This poses the research challenge of misclassification of disease, as well as the clinical difficulty of potentially inappropriate treatment … Since patients are drawn from the city-wide registry, clustering of genetic and behavioral risk factors will be systematically identified without the selection bias inherent in case series and clinic-based studies.

Research questions:

  1. Is it feasible to distinguish type 1 from early-onset type 2 diabetes at diagnosis? Which demographic, clinical, and family characteristics are most useful?
  2. Is the risk of developing diabetes among siblings of early-onset type 2 or mixed cases equivalent to that for siblings of type 1 patients? Which characteristics are most predictive of risk? Hypothesis 2. Changes in the epidemiologic parameters of childhood diabetes over the past 2 decades are directly related to changes in the prevalence of risk factors for both type 1 and type 2 diabetes, including obesity, physical inactivity, and perinatal exposures.

Research questions:

  1. Is change in the incidence of childhood diabetes occurring uniformly across all age-, sex- and ethnic strata?
  2. Are secular changes in type 2 incidence rates continuing, and is this occurring in all age-, sex- and ethnic strata? Hypothesis 3. A complex interplay of heritable, behavioral, and treatment factors can accelerate or delay the development of chronic diabetes complications. It is particularly compelling to understand this process in young patients, those with the most years of productive life at risk. … Recent observations indicate that features of the metabolic syndrome, over and above glycemic control, are potent risk factors for macrovascular complications. Familial aggregation of these traits may itself play a role in determining the risk of chronic complications among young people with diabetes.

Research questions:

  1. Do young people with diabetes who demonstrate signs and symptoms of early complications have greater insulin resistance or other characteristics that distinguish them from those patients who are free of complications, controlled for disease duration and metabolic control?
  2. Do young patients with early signs/symptoms of complications have more parents who themselves have elevated cardiovascular disease risk factors, than patients who are free of chronic complications, controlled for disease duration and metabolic control?

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2400

Kontakter og lokationer

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

Studiesteder

    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • The University of Chicago, Biological Sciences Division, Pritzker School of Medicine

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

Ikke ældre end 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

target all diagnosed with diabetes before age 18 AND resident of the City of Chicago at diagnosis

Beskrivelse

Inclusion Criteria:

  • diagnosed with diabetes before age 18 AND resident of the City of Chicago at diagnosis

Exclusion Criteria:

  • diabetes secondary to another condition, e.g. cystic fibrosis

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kun etui

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Rebecca B Lipton, PhD, University of Chicago

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.

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. juli 1992

Primær færdiggørelse (Faktiske)

1. september 2005

Studieafslutning (Faktiske)

1. september 2005

Datoer for studieregistrering

Først indsendt

13. september 2005

Først indsendt, der opfyldte QC-kriterier

13. september 2005

Først opslået (Skøn)

20. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • R01DK044752 (U.S. NIH-bevilling/kontrakt)
  • IRB Protocol #s:
  • 11348B;
  • 11564B;
  • 12323B

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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