Brain Natriuretic Peptide Effects on Appetite Regulating Hormones and Endothelial Derived Peptides
Condition: Healthy
Study type: Interventional

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.
    

Detailed description: 
      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      Blood samples will be withdrawn twice at baseline (time points -5 minutes and 0 minutes) and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.
    

Intervention name(s): BNP; 0.9% NaCl
Intervention type(s): Drug; Drug
Intervention description(s): 3.0 pmol/kg/min human active BNP administered as a continuous intravenous infusion during four hours; 0.9% NaCl administered as a continuous intravenous infusion during four hours
Other intervention name(s): saline solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: BNP administration; appetite; ghrelin; PYY