Effects of Brain Natriuretic Peptide on Appetite-regulating Hormones and Endothelial-derived Peptides
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Changes in hunger scores on the visual analog scales (VAS) over time as compared to baseline (measured in mm)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Placebo
0,9% NaCl administered as a continuous intravenous infusion during four hours.
干预措施: 0.9% NaCl (Drug)
BNP
3.0 pmol/kg/min human active BNP administered as a continuous intravenous infusion during four hours.
干预措施: BNP (Drug)
结局指标
主要结局
Changes in hunger scores on the visual analog scales (VAS) over time as compared to baseline (measured in mm)
时间窗: 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.
Changes in satiety scores on the VAS over time as compared to baseline (measured in mm)
时间窗: 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.
Changes in plasma concentrations of ghrelin and acylated ghrelin over time as compared to baseline
时间窗: 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.
Changes in plasma concentrations of peptide YY (PYY) over time as compared to baseline
时间窗: 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.
次要结局
- 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.)
研究者
Anton Luger
Professor
Medical University of Vienna