Clinical Trials Directory

Trials / Completed

CompletedNCT03933787

Neuropeptide Y and Sympathovagal Balance

Neuropeptide Y Function in the Sympathovagal Balance During an Ergometric Test in Healthy Volunteers

Status
Completed
Phase
EARLY_Phase 1
Study type
Interventional
Enrollment
7 (actual)
Sponsor
Eric Grouzmann · Academic / Other
Sex
Male
Age
24 Years – 30 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGSaxagliptin 5mgRandomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin
DRUGPlacebo oral capsuleRandomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin
OTHERergometric test in healthy volunteersThe volunteers will undergo an ergometric test in each session

Timeline

Start date
2018-06-05
Primary completion
2018-07-18
Completion
2019-04-15
First posted
2019-05-01
Last updated
2019-05-01

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03933787. Inclusion in this directory is not an endorsement.