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Effect of Acute Exercise on Endothelial Function in Patients With Type 1 Diabetes. (EAEEFD)

11. juli 2013 opdateret af: Beatriz D'Agord Schaan, Hospital de Clinicas de Porto Alegre

Acute Effects of Aerobic and Resistance Exercise on Endothelial Function in Patients With Type 1 Diabetes.

The aim of this study is to evaluate the effect of a single session of aerobic plus resistance exercises on the vascular function of patients with type 1 diabetes mellitus. The investigators hypothesize that a single aerobic exercise session would promote greater benefit in vascular function of patients with type 1 diabetes, as compared with the resistive exercise session.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The aim of this study is to compare the effect of endurance and resistance exercises on endothelial function in patients with type 1 diabetes mellitus (T1DM). For this purpose, the sample size will consist of 15 patients with DM1, aged between 18 and 45 years, which will undertake the two types of exercises, randomly distributed. Ergospirometry testing will be performed in order to assess possible contraindications to the proposed protocol as well as functional capacity, which will be used in prescription of the endurance exercise session. Similarly, a strength maximal testing will be conducted and used in the prescription of the resistance exercise session.

The endothelial function will be evaluated by vascular reactivity of the forearm and circulating endothelial progenitor cells (EPC) counting. To analyze the vascular reactivity of the forearm, non-invasive venous occlusion plethysmography will be used, whereas flow cytometry method will be used to the analysis of the number of circulating EPC. The endurance exercise session will consist of 40 minutes of cycling on heart rate corresponding to 60% of VO2 max. The resistance exercise session will last 40 minutes, consisting of 4 sets of 12 repetitions at 60% of 1RM, in four exercises for lower limbs. The research will be performed at the Exercise Pathophysiology Research Laboratory of the Hospital de Clinicas de Porto Alegre. The investigators expect to find greater increase in the number of circulating EPC after the endurance exercise session, when compared to the benefits obtained from a session of resistance exercise. Likewise, it is expected to find greater benefits in relation to vascular reactivity of the forearm after a session of endurance exercise when compared to a session of resistance exercise. Considering that most part of the studies that analyze the effects of physical exercise on vascular function does not involve patients with DM1, this project aims to provide a clearer picture of the benefits of different exercises in the acute response of endothelial function in these patients.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Brasilien
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90035903
        • Rekruttering
        • Hospital de Clínicas de Porto Alegre
        • Kontakt:

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

18 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Type 1 diabetes
  • Male gender
  • 18-45 years old

Exclusion Criteria:

  • Severe autonomic neuropathy
  • Diabetic nephropathy established
  • Chronic kidney failure
  • Limb amputation
  • Disabling peripheral arterial disease
  • Coronary artery disease
  • Heart failure
  • Diabetic proliferative retinopathy
  • Neoplasms
  • Smokers
  • Regular physical training

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patients with type 1 diabetes
Adfærdsmæssigt: Resistance exercise session
Resistance exercise session consisting of 4 lower-limb exercises, with 4 sets, 12 repetitions per set, at an intensity of 60% of maximal strength.
Adfærdsmæssigt: Aerobic exercise session
Aerobic exercise session consisting of 40 minutes of lower-limb bicycle.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Circulating endothelial progenitor cells
Tidsramme: 10 minutes before the exercise session and 10 minutes after the exercise session.
A 20-ml sodium heparin tube will be used and peripheral blood mononuclear cells (PBMC) will be isolated by Ficoll-Hypaque. Blood samples will be diluted with PBS and layered onto Ficoll-Hypaque in 15-ml tubes. Tubes will be centrifuged at 400 g for 30 min and the PBMC at the interface will be collected. Cells will be washed with RPMI 1640 medium and thereafter stained with 5 µl of anti-CD45-FITC , 8 µl of anti-KDR-Alexa Fluor 647, and 5 µl of anti-CD34-PE (all essays from BD, Biosciences, USA). Thereafter, 50 µl of resuspended cells will be incubated (30 min), and subsequently, 500 µl of PBS will be added for acquisition. A FACS Calibur flow cytometer will be used with Quest software (BD Biosciences, USA) equipped with 22 mW argon laser tuned at 488 nm, with a total number counted cells of 200,000 on mononuclear cells gate per sample. Percentage of CD34 positive cells will be calculated based on the number of leukocytes .
10 minutes before the exercise session and 10 minutes after the exercise session.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forearm vascular reactivity
Tidsramme: 10 minutes before the exercise session and 10 minutes after the exercise session.

Forearm blood flow and reactive hyperemia:

Forearm blood flow will be measured by venous occlusion plethysmography (D.E Hokanson, USA) at the nondominant forearm. A rapid inflator cuff will be used in the upper arm to occlude venous outflow (50-60 mmHg), and three blood flow recordings will be made each minute during 3 minutes. Thereafter, reactive hyperemia will be measure using an occlusion at 250 mmHg for 5 min, which will be released by 10 seconds intervals for 2 minutes. Reactive hyperemia will be calculated using the peak blood flow after the 5 minutes the occlusion.
10 minutes before the exercise session and 10 minutes after the exercise session.

Samarbejdspartnere og efterforskere

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

Sponsor

Hospital de Clinicas de Porto Alegre

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. december 2011

Primær færdiggørelse (Forventet)

1. november 2013

Studieafslutning (Forventet)

1. december 2013

Datoer for studieregistrering

Først indsendt

8. juli 2013

Først indsendt, der opfyldte QC-kriterier

11. juli 2013

Først opslået (Skøn)

16. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. juli 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juli 2013

Sidst verificeret

1. juli 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 100400

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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