Neuropeptide Y Function in the Sympathovagal Balance During an Ergometric Test in Healthy Volunteers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Heart rate change variability assessed at the end of each exercise
研究概览
简要总结
Neuropeptide Y (NPY) activates the sympathetic and vagal nervous systems through the Y1 and Y2 receptors. This double-blind placebo-controlled crossover study investigated the sympathovagal balance during three exercises on a cycloergometer in healthy volunteers treated with saxagliptin (DPP4 inhibitor).
详细描述
Pharmacological studies indicate that NPY has a role as a co-transmitter associated with catecholamines to maintain cardiovascular homeostasis. The development of a selective and sensitive assay of NPY1-36 (vasoconstrictor) and NPY3-36 (vasodilator) by LC-MS/MS will confirm this modulating role of NPY in sympatho vagal balance in healthy young subjects. This project should lead to a better understanding of the contribution of NPY to exercise physiology through a double-blind randomized study using a DPP4 inhibitor (Saxagliptin) used for the treatment of type 2 diabetes, blocking the formation of NPY3-36 and thus enhancing the effect of NPY1-36. The interest of this study will be to find targets other than adrenergic receptors in the regulation of sympathetic and parasympathetic systems during exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participants, investigator and care provider were not aware when the placebo or Saxagliptin was provided. The biochemical assays were performed in a random order with anonymised sample numbers. The data were analysed before revealing to which session each participant received the placebo or Sitagliptin
入排标准
- 年龄范围
- 24 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged between 18 and 30 years.
- •Non smoking
- •Practicing at least 3 hours physical activity per week
- •Absence of significant findings in the medical history and physical examination as judged by the Investigator, especially for cardiovascular, pulmonary, haematological and nervous systems
- •Ability to understand the procedures, agreement to participate and willingness to give written informed consent
- •Co-operative attitude and availability for scheduled visits over the entire study period.
排除标准
- •Use of any medication the week prior to study. Paracetamol is permissible before and during study as a concomitant medication but only with Investigator's permission.
- •History of major cardiovascular, pulmonary, hepatic, immunological, renal, haematological, gastrointestinal, genitourinary, neurological, or rheumatologic disorders
- •rhinosinusitis
- •Urinary tract infection
- •Hypertension defined as supine blood pressure >150/90 mmHg or recurrent hypotensive events considered as clinically relevant or documented orthostatic hypotension
研究组 & 干预措施
mannitol in a tablet
two tablets containing mannitol in a blister: one tablet provided to each volunteer in a blister 16 hours before the trial and one tablet provided two hours before the clinical trial
干预措施: Placebo oral capsule (Drug)
mannitol in a tablet
two tablets containing mannitol in a blister: one tablet provided to each volunteer in a blister 16 hours before the trial and one tablet provided two hours before the clinical trial
干预措施: ergometric test in healthy volunteers (Other)
Saxagliptin in a tablet
two tablets containing each 5 mg of Saxagliptin in a blister: one tablet provided to each volunteer in a blister 16 hours before the trial and one tablet provided two hours before the clinical trial
干预措施: Saxagliptin 5mg (Drug)
Saxagliptin in a tablet
two tablets containing each 5 mg of Saxagliptin in a blister: one tablet provided to each volunteer in a blister 16 hours before the trial and one tablet provided two hours before the clinical trial
干预措施: ergometric test in healthy volunteers (Other)
结局指标
主要结局
Heart rate change variability assessed at the end of each exercise
时间窗: 5 hours and 30 minutes
normalized low frequency (nLF) measurement
次要结局
- NPY 1-36 secretion(5 hours and 30 minutes)
- NPY3-36 secretion(5 hours and 30 minutes)
- Catecholamine secretion(5 hours and 30 minutes)
- NPY 3-36 secretion(5 hours and 30 minutes)
研究者
Eric Grouzmann
Head of laboratory
Centre Hospitalier Universitaire Vaudois