Brain Natriuretic Peptide Effects on Appetite Regulating Hormones and Endothelial Derived Peptides

NCT01375153 | Completed

• 1 other identifier: 060/2009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy

Keywords

BNP administration; appetite; ghrelin; PYY

Outcome Measures

Primary Outcomes (4)

• Changes in hunger scores on the visual analog scales (VAS) over time as compared to baseline (measured in mm)

  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)

  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

  Blood samples will be withdrawn from an intravenous cannula placed circa 10 minutes before the start of the study in the left antecubital vein.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

  Blood samples will be withdrawn from an intravenous cannula placed circa 10 minutes before the start of the study in the left antecubital vein.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.

Secondary Outcomes (4)

• Changes in plasma concentrations of glucose and adiponectin over time as compared to baseline

  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

  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

  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

  Timepoints -5, 0, 60, 120, 180 and 240 minutes.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

0,9% NaCl administered as a continuous intravenous infusion during four hours.

Drug: 0.9% NaCl

BNP

ACTIVE COMPARATOR

3.0 pmol/kg/min human active BNP administered as a continuous intravenous infusion during four hours.

Drug: BNP

Interventions

BNP DRUG

3.0 pmol/kg/min human active BNP administered as a continuous intravenous infusion during four hours

BNP

0.9% NaCl DRUG

0.9% NaCl administered as a continuous intravenous infusion during four hours

Also known as: saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (2)

Medical University of Vienna

Vienna, 1090, Austria

Location

AKH, Medical University of Vienna

Vienna, A-1090, Austria

Location

Related Publications (1)

• Vila G, Grimm G, Resl M, Heinisch B, Einwallner E, Esterbauer H, Dieplinger B, Mueller T, Luger A, Clodi M. B-type natriuretic peptide modulates ghrelin, hunger, and satiety in healthy men. Diabetes. 2012 Oct;61(10):2592-6. doi: 10.2337/db11-1466. Epub 2012 Jun 14.

  PMID: 22698919 RESULT

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Anton Luger, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 17, 2011
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

AU (2)