Neuropeptide Y and Sympathovagal Balance

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03933787

Acronym

NPY

Enrollment

Registered

2019-05-01

Start date

2018-06-05

Completion date

2019-04-15

Last updated

2019-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity, Secretion; Catecholamine, Sympathetic Nervous System

Keywords

neuropeptide Y,catecholamine, exercise

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.

Interventions

DRUGSaxagliptin 5mg

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

DRUGPlacebo oral capsule

Randomised 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 volunteers

The volunteers will undergo an ergometric test in each session

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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

Intervention model description

double-blind placebo-controlled crossover study

Eligibility

Sex/Gender

MALE

Age

24 Years to 30 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Heart rate change variability assessed at the end of each exercise	5 hours and 30 minutes	RMSSD (Root mean square of successive RR interval differences) measurement

Secondary

Measure	Time frame	Description
NPY 1-36 secretion	5 hours and 30 minutes	half-life \[t1/2\]
NPY 3-36 secretion	5 hours and 30 minutes	Half-life \[t1/2\]
NPY3-36 secretion	5 hours and 30 minutes	Area under the plasma concentration versus time curve \[AUC\]
Catecholamine secretion	5 hours and 30 minutes	Half-life \[t1/2\]

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026