Healthy Clinical Trial
Official title:
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.
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Blood samples will be withdrawn twice at baseline (time points -5 minutes and 0 minutes) and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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
| Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
| Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
| Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
| Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
| Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
| Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
| Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
| Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
| Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
| Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
| Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
| Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
| Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
| Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
| Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
| Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
| Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |