Ignite Creation Date:
2024-05-05 @ 11:38 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01375153
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2011-05-31
Brief Title:
Brain Natriuretic Peptide Effects on Appetite Regulating Hormones and Endothelial Derived Peptides
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
Effects of Brain Natriuretic Peptide on Appetite-regulating Hormones and Endothelial-derived Peptides
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BNPAppetite
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
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 dayssessions separated by a washout period of at least two weeks The sessions will last approximately 45 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 30 pmolkgmin 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 45 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 -20C 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 1201 statistical software
Each subject will participate in two study dayssessions separated by a washout period of at least two weeks The sessions will last approximately 45 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 30 pmolkgmin 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 45 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 -20C 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 1201 statistical software
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None