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

4. April 2017 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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Blood samples will be withdrawn twice at baseline (time points -5 minutes and 0 minutes) and hourly afterwards.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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

10

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 60 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Männlich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
0,9% NaCl administered as a continuous intravenous infusion during four hours.
Arzneimittel: 0.9% NaCl
0.9% NaCl administered as a continuous intravenous infusion during four hours
Andere Namen:
  • Kochsalzlösung
Aktiver Komparator: BNP
3.0 pmol/kg/min human active BNP administered as a continuous intravenous infusion during four hours.
Arzneimittel: BNP
3.0 pmol/kg/min human active BNP administered as a continuous intravenous infusion during four hours

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in hunger scores on the visual analog scales (VAS) over time as compared to baseline (measured in mm)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in plasma concentrations of glucose and adiponectin over time as compared to baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Medical University of Vienna

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2010

Primärer Abschluss (Tatsächlich)

1. März 2011

Studienabschluss (Tatsächlich)

1. Mai 2011

Studienanmeldedaten

Zuerst eingereicht

31. Mai 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. Juni 2011

Zuerst gepostet (Schätzen)

17. Juni 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. April 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. April 2017

Zuletzt verifiziert

1. April 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 060/2009

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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