Clinical trial NCT03933787: Neuropeptide Y and Sympathovagal Balance
Official title: Neuropeptide Y Function in the Sympathovagal Balance During an Ergometric Test in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Physical Activity
Sympathetic Nervous System
Secretion; Catecholamine
Keywords: neuropeptide Y,catecholamine, exercise
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: grégoire wuerzner
name: grégoire millet
name: Nicolas Bourdillon
name: Philippe Eugster
First posted: 2019-05-01
Enrollment: 7
Sex: MALE
Minimum age (years): 24
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: double-blind placebo-controlled crossover study
Primary purpose: BASIC_SCIENCE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects aged between 18 and 30 years.
2. Non smoking
3. Practicing at least 3 hours physical activity per week
4. Absence of significant findings in the medical history and physical examination as judged by the Investigator, especially for cardiovascular, pulmonary, haematological and nervous systems
5. Ability to understand the procedures, agreement to participate and willingness to give written informed consent
6. Co-operative attitude and availability for scheduled visits over the entire study period.

Exclusion Criteria:

1. 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.
2. History of major cardiovascular, pulmonary, hepatic, immunological, renal, haematological, gastrointestinal, genitourinary, neurological, or rheumatologic disorders
3. rhinosinusitis
4. Urinary tract infection
5. Hypertension defined as supine blood pressure \>150/90 mmHg or recurrent hypotensive events considered as clinically relevant or documented orthostatic hypotension

Primary outcomes:
measure: Heart rate change variability assessed at the end of each exercise
timeFrame: 5 hours and 30 minutes
measure: Heart rate change variability assessed at the end of each exercise
timeFrame: 5 hours and 30 minutes
Secondary outcomes:
measure: NPY 1-36 secretion
timeFrame: 5 hours and 30 minutes
measure: NPY 1-36 secretion
timeFrame: 5 hours and 30 minutes
measure: NPY 1-36 secretion
timeFrame: 5 hours and 30 minutes
measure: NPY 3-36 secretion
timeFrame: 5 hours and 30 minutes
measure: NPY3-36 secretion
timeFrame: 5 hours and 30 minutes
measure: NPY3-36 secretion
timeFrame: 5 hours and 30 minutes
measure: Catecholamine secretion
timeFrame: 5 hours and 30 minutes
measure: Catecholamine secretion
timeFrame: 5 hours and 30 minutes
measure: Catecholamine secretion
timeFrame: 5 hours and 30 minutes
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Service de Néphrologie
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Eric Grouzmann, Dr
role: PRINCIPAL_INVESTIGATOR
References: