Neuropeptide Y and Sympathovagal Balance

Early Phase 1CompletedNCT03933787

Eric Grouzmann7 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Physical Activity Sympathetic Nervous System Secretion; Catecholamine

Interventions

Saxagliptin 5mgDRUG

Randomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin

Placebo oral capsuleDRUG

Randomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin

ergometric test in healthy volunteersOTHER

The volunteers will undergo an ergometric test in each session

Eligibility

Sex: MALEMin age: 24 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Service de Néphrologie

Lausanne, Canton of Vaud, Switzerland