Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Brain Natriuretic Peptide Effects on Appetite Regulating Hormones and Endothelial Derived Peptides (BNP/Appetite)

4 april 2017 uppdaterad av: Anton Luger, Medical University of Vienna

Effects of Brain Natriuretic Peptide on Appetite-regulating Hormones and Endothelial-derived Peptides

Chronic heart failure is accompanied by anorexia and increased release of B-type natriuretic peptide (BNP) from the ventricular myocytes. The pathophysiological mechanisms linking heart failure and appetite-regulation remain unknown. This study aims to examine the impact of exogenous BNP administration on subjective ratings of hunger and satiety, and on appetite-regulating hormones in a placebo-controlled cross-over study performed in ten healthy human volunteers.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a prospective, single blinded randomized, placebo-controlled, cross-over study, which will be conducted in ten healthy volunteers.

Each subject will participate in two study days/sessions, separated by a washout period of at least two weeks. The sessions will last approximately 4.5 hours. The subjects will come after having fasted overnight. Two intravenous cannulas will be placed in the right and left antecubital vein for infusions and blood sampling, respectively.

The subjects will receive intravenously once placebo and once 3.0 pmol/kg/min human active BNP (BNP-32) as a continuous intravenous infusion given during 4 hours (between time points 0 and 240 minutes). The order of study drugs will be randomized.

During the whole study session (lasting about 4.5 hours) the subject will remain fasted and confined to bed rest.

The changes in subjective ratings of hunger and satiety over time will be evaluated by 100 mm visual analog scales (VAS) half-hourly (between time points 0 and 240 minutes). Herewith the subjects rate their feeling of hunger (Hunger-VAS forms include the question: How hungry do you feel? Subjects are required to mark their feeling of hunger in a scale from 0 to 100 mm) and satiety (Satiety-VAS forms include the question: How satt do you feel? Subjects are required to mark their feeling of hunger in a scale from 0 to 100 mm).

Blood samples will be withdrawn twice at baseline (time points -5 minutes and 0 minutes) and hourly afterwards. Samples will be immediately cooled on ice, centrifuged at 3000 rpm for 10 minutes and then stored at -20°C for the later measurement of ghrelin, peptide YY, adiponectin, corticotropin, cortisol, adrenaline, noradrenaline, insulin, adrenomedullin, endothelin, copeptin, growth differentiation factor 15, BNP and atrial natriuretic peptide. All assays will be performed using commercial radioimmunoassays and enzyme-linked immunosorbent assays at the very end of the study with samples belonging to (both study days) one subject being measured within one kit.

The changes in VAS and hormone concentrations over time will be evaluated using repeated measurements analysis of variance (ANOVA) using the SPSS release 12.0.1 statistical software.

Studietyp

Interventionell

Inskrivning (Faktisk)

10

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Österrike
      • Vienna, Österrike, 1090
        • Medical University of Vienna
      • Vienna, Österrike, A-1090
        • AKH, Medical University of Vienna

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 60 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Manlig

Beskrivning

Inclusion Criteria:

  • Men aged 18 to 40 years
  • written informed consent
  • BMI < 25 kg/m2
  • no concomitant diseases
  • BNP level within the normal range
  • Normal renal function (serum creatinine of less then 1.2 mg/dL and/or creatinin clearance greater than 80ml/min)

Exclusion Criteria:

  • systolic blood pressure < 90 mmHg
  • impaired glucose tolerance or diabetes mellitus
  • hyperthyroidism, hypothyroidism
  • hepatic, renal or cardiovascular diseases
  • malignancies
  • history of medical therapy within 3 weeks prior to enrolment into the study
  • history of anaphylaxis

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo
0,9% NaCl administered as a continuous intravenous infusion during four hours.
Läkemedel: 0.9% NaCl
0.9% NaCl administered as a continuous intravenous infusion during four hours
Andra namn:
  • saltlösning
Aktiv komparator: BNP
3.0 pmol/kg/min human active BNP administered as a continuous intravenous infusion during four hours.
Läkemedel: BNP
3.0 pmol/kg/min human active BNP administered as a continuous intravenous infusion during four hours

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in hunger scores on the visual analog scales (VAS) over time as compared to baseline (measured in mm)
Tidsram: Time points -5, 0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Subjects will be asked to rate their feeling of hunger in 100 mm VAS half-hourly (between time points 0 and 240 minutes).

Hunger-VAS forms include the question: How hungry do you feel? Subjects are required to mark their feeling of hunger in a scale of 0 to 100 mm.
Time points -5, 0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Changes in satiety scores on the VAS over time as compared to baseline (measured in mm)
Tidsram: Time points -5, 0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes

Subjects will be asked to rate their feeling of satiety in 100 mm VAS half-hourly (between time points 0 and 240 minutes).

Satiety-VAS forms include the question: How satt do you feel? Subjects are required to mark their feeling of satiety in a scale of 0 to 100 mm.
Time points -5, 0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes
Changes in plasma concentrations of ghrelin and acylated ghrelin over time as compared to baseline
Tidsram: Timepoints -5, 0, 60, 120, 180 and 240 minutes.
Blood samples will be withdrawn from an intravenous cannula placed circa 10 minutes before the start of the study in the left antecubital vein. Samples will be immediately cooled on ice, centrifuged at 3000 rpm for 10 minutes and then stored at -20°C for the later measurement of ghrelin and acylated ghrelin. All assays will be performed using commercial assay kits at the very end of the study with samples belonging to (both study days) one subject being measured within one kit.
Timepoints -5, 0, 60, 120, 180 and 240 minutes.
Changes in plasma concentrations of peptide YY (PYY) over time as compared to baseline
Tidsram: Timepoints -5, 0, 60, 120, 180 and 240 minutes.
Blood samples will be withdrawn from an intravenous cannula placed circa 10 minutes before the start of the study in the left antecubital vein. Samples will be immediately cooled on ice, centrifuged at 3000 rpm for 10 minutes and then stored at -20°C for the later measurement of PYY. All PYY assays will be performed using commercial radioimmunoassay kits at the very end of the study with samples belonging to (both study days) one subject being measured within one kit.
Timepoints -5, 0, 60, 120, 180 and 240 minutes.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in plasma concentrations of glucose and adiponectin over time as compared to baseline
Tidsram: During two study sessions lasting 4 hours each and performed at least two weeks apart. Blood samples will be taken twice at baseline and then hourly afterwards (between time-points 0 minutes and 240 minutes)
Blood samples will be withdrawn from an intravenous cannula placed circa 10 minutes before the start of the study in the left antecubital vein. Glucose will be routinely measured in a certified laboratory (www.kimcl.at). Samples for the measurement of adiponectin will be immediately cooled on ice, centrifuged at 3000 rpm for 10 minutes and then stored at -20°C. All adiponectin assays will be performed using commercial kits at the very end of the study with samples belonging to (both study days) one subject being measured within one kit.
During two study sessions lasting 4 hours each and performed at least two weeks apart. Blood samples will be taken twice at baseline and then hourly afterwards (between time-points 0 minutes and 240 minutes)
Changes in plasma concentrations of cortisol, adrenaline and noradrenaline over time as compared to baseline
Tidsram: Timepoints -5, 0, 60, 120, 180 and 240 minutes.
Blood samples will be withdrawn from an intravenous cannula placed circa 10 minutes before the start of the study in the left antecubital vein. Samples will be immediately cooled on ice, centrifuged at 3000 rpm for 10 minutes and then stored at -20°C for the later measurement of cortisol, adrenaline and noradrenaline. These assays will be performed using commercial kits used for routine purposes at a certified laboratory (www.kimcl.at) at the very end of the study with samples belonging to (both study days) one subject being measured within one kit.
Timepoints -5, 0, 60, 120, 180 and 240 minutes.
Changes in plasma concentrations of B-type natriuretic peptide (BNP) and atrial natriuretic peptide (ANP) over time as compared to baseline
Tidsram: Timepoints -5, 0, 60, 120, 180 and 240 minutes.
Blood samples will be withdrawn from an intravenous cannula placed circa 10 minutes before the start of the study in the left antecubital vein in vacutainers containing heparin. Samples will be immediately cooled on ice, centrifuged at 3000 rpm for 10 minutes and then stored at -20°C for the later measurement of BNP and ANP. These assays will be performed using commercial kits used for routine purposes at a certified laboratory at the very end of the study with samples belonging to (both study days) one subject being measured within one kit.
Timepoints -5, 0, 60, 120, 180 and 240 minutes.
Changes in plasma concentrations of endothelial derived factors (endothelin, adrenomedullin and growth differentiation factor 15) over time as compared to baseline
Tidsram: Timepoints -5, 0, 60, 120, 180 and 240 minutes.
Blood samples will be withdrawn from an intravenous cannula placed circa 10 minutes before the start of the study in the left antecubital vein. Samples will be immediately cooled on ice, centrifuged at 3000 rpm for 10 minutes and then stored at -20°C. All assays for adrenomedullin, endothelin and growth differentiation factor 15 will be performed using commercial kits used for routine purposes at a certified laboratory at the very end of the study with samples belonging to (both study days) one subject being measured within one kit.
Timepoints -5, 0, 60, 120, 180 and 240 minutes.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Medical University of Vienna

Utredare

  • Huvudutredare: Anton Luger, MD, Medical University of Vienna

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2010

Primärt slutförande (Faktisk)

1 mars 2011

Avslutad studie (Faktisk)

1 maj 2011

Studieregistreringsdatum

Först inskickad

31 maj 2011

Först inskickad som uppfyllde QC-kriterierna

16 juni 2011

Första postat (Uppskatta)

17 juni 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 april 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 april 2017

Senast verifierad

1 april 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • 060/2009

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Friska

Kliniska prövningar på 0.9% NaCl

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Jamaica

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera