Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The Microvascular Complications Study

31. juli 2012 opdateret af: University of Minnesota

Microvascular Complications of Cystic Fibrosis Related Diabetes

Our general aim is to determine the prevalence of diabetic microvascular complications in CFRD patients with and without fasting hyperglycemia, and to explore whether the presence of these complications is related to diabetes or CF factors. This cross-sectional study will provide pilot data for a longitudinal study of diabetes complications in CF.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

Microvascular complications of diabetes such as eye, kidney and nerve disease are common in individuals with type 1 and type 2 diabetes, and are a source of significant morbidity and mortality. Microvascular diabetes complications have been anecdotally reported in cystic fibrosis related diabetes (CFRD), but their prevalence is unknown. 40% of adult CF patients have CFRD, which shares features of both type 1 and type 2 diabetes but is a distinct clinical entity (1). Many clinicians are reluctant to add the burden of aggressive diabetes management to the already complex medical regimen of these patients. It is sometimes stated that they will not live long enough to develop complications of diabetes. However, longevity in CF has dramatically increased, and many patients now live into their thirties, forties, and fifties. As they live longer, it becomes increasingly likely that at least some will develop diabetes complications. A better understanding of this negative outcome would help resolve the question of whether aggressive screening and management of diabetes is necessary in CF.

As in other forms of diabetes, duration of diabetes and the magnitude of chronic hyperglycemia are probably important determinants of microvascular complications in CFRD. This information is not usually known at the time of presentation of CFRD because of the insidious onset of the disease. Theoretically, CF pulmonary disease, including chronic hypoxia and venous congestion related to pulmonary hypertension, may additionally aggravate microvascular changes. However, the metabolic differences between CFRD and type 1 and type 2 diabetes may also serve to protect CF patients from some diabetes complications. At the time diabetes complications develop, patients with type 1 and type 2 diabetes tend to have concomitant obesity, hypertension, insulin resistance, hyperlipidemia and atherosclerotic cardiovascular disease. These factors, which are generally absent in CF, may contribute to the pathophysiology of microvascular complications in other forms of diabetes.

The University of Minnesota CF Center is in the unique position of having a well-characterized diabetes population, since diabetes screening was instituted several years ago as part of routine annual CF studies. In our population of 450 CF patients, 113 have been diagnosed with diabetes, and the remainder are known to have either normal or impaired glucose tolerance. In addition to our CFRD experience, the University of Minnesota has a strong background of experience in large population-based screening and intervention trials concerning diabetes complications. Not only were we a participating center in the NIH-sponsored multi-center Diabetes Control and Complications Trial (DCCT) (2) and the current DCCT follow-up Epidemiology of Diabetes Interventions and Complications trial (EDIC), but our laboratory was central reference laboratory for the DCCT and EDIC. Thus, our physicians, nurses, biostatisticians, GCRC staff and laboratory staff are all quite knowledgeable and experienced in the methods to be used in the present application.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

150

Kontakter og lokationer

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

Studiesteder

    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

CFRD Patients

Beskrivelse

Inclusion Criteria:

CFRD patients with and without fasting hyperglycemia

Exclusion Criteria:

None

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tidsperspektiver: Fremadrettet

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Antoinette Moran, MD, University of Minnesota

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. april 2001

Studieafslutning

1. juli 2005

Datoer for studieregistrering

Først indsendt

14. september 2005

Først indsendt, der opfyldte QC-kriterier

14. september 2005

Først opslået (Skøn)

22. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. august 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. juli 2012

Sidst verificeret

1. juli 2012

Mere information

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 .

Abonner