Neuropeptide Y and Sympathovagal Balance

Physical Activity Clinical Trial

— NPY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03933787
• Other study ID #: 2018-00569
• Status: Completed
• Phase: Early Phase 1
• Start date: June 5, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: April 2019
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 15, 2019
• Est. primary completion date: July 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 24 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Physical Activity
• Secretion; Catecholamine
• Sympathetic Nervous System

Intervention

Drug:
• Saxagliptin 5mg
Randomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin
• Placebo oral capsule
Randomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin

Other:
• ergometric test in healthy volunteers
The volunteers will undergo an ergometric test in each session

Locations

Country	Name	City	State
Switzerland	Service de Néphrologie	Lausanne	Vaud

Sponsors (5)

Lead Sponsor	Collaborator
Eric Grouzmann	grégoire millet, grégoire wuerzner, Nicolas Bourdillon, Philippe Eugster

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate change variability assessed at the end of each exercise	RMSSD (Root mean square of successive RR interval differences) measurement	5 hours and 30 minutes
Primary	Heart rate change variability assessed at the end of each exercise	normalized low frequency (nLF) measurement	5 hours and 30 minutes
Secondary	NPY 1-36 secretion	half-life [t1/2]	5 hours and 30 minutes
Secondary	NPY 1-36 secretion	Area under the plasma concentration versus time curve [AUC]	5 hours and 30 minutes
Secondary	NPY 1-36 secretion	Peak Plasma Concentration [Cmax]	5 hours and 30 minutes
Secondary	NPY 3-36 secretion	Half-life [t1/2]	5 hours and 30 minutes
Secondary	NPY3-36 secretion	Area under the plasma concentration versus time curve [AUC]	5 hours and 30 minutes
Secondary	NPY3-36 secretion	Peak Plasma Concentration [Cmax]	5 hours and 30 minutes
Secondary	Catecholamine secretion	Half-life [t1/2]	5 hours and 30 minutes
Secondary	Catecholamine secretion	Area under the plasma concentration versus time curve [AUC]	5 hours and 30 minutes
Secondary	Catecholamine secretion	Peak Plasma Concentration [Cmax]	5 hours and 30 minutes