Neuropeptide Y and Sympathovagal Balance

NCT03933787 | Completed Early Phase 1

• 1 other identifier: 2018-00569
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Physical Activity; Sympathetic Nervous System; Secretion; Catecholamine

Keywords

neuropeptide Y,catecholamine, exercise

Outcome Measures

Primary Outcomes (2)

• 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

• Heart rate change variability assessed at the end of each exercise

  normalized low frequency (nLF) measurement

  5 hours and 30 minutes

Secondary Outcomes (9)

• NPY 1-36 secretion

  5 hours and 30 minutes

• NPY 1-36 secretion

  5 hours and 30 minutes

• NPY 1-36 secretion

  5 hours and 30 minutes

• NPY 3-36 secretion

  5 hours and 30 minutes

• NPY3-36 secretion

  5 hours and 30 minutes

Study Arms (2)

mannitol in a tablet

PLACEBO COMPARATOR

two tablets containing mannitol in a blister: one tablet provided to each volunteer in a blister 16 hours before the trial and one tablet provided two hours before the clinical trial

Drug: Placebo oral capsule; Other: ergometric test in healthy volunteers

Saxagliptin in a tablet

ACTIVE COMPARATOR

two tablets containing each 5 mg of Saxagliptin in a blister: one tablet provided to each volunteer in a blister 16 hours before the trial and one tablet provided two hours before the clinical trial

Drug: Saxagliptin 5mg; Other: ergometric test in healthy volunteers

Interventions

Saxagliptin 5mg DRUG

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

Saxagliptin in a tablet

Placebo oral capsule DRUG

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

mannitol in a tablet

ergometric test in healthy volunteers OTHER

The volunteers will undergo an ergometric test in each session

Saxagliptin in a tablet; mannitol in a tablet

Eligibility Criteria

• Age: 24 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eric Grouzmann: lead
• grégoire wuerzner: collaborator
• grégoire millet: collaborator
• Nicolas Bourdillon: collaborator
• Philippe Eugster: collaborator

Study Sites (1)

Service de Néphrologie

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Motor Activity

Interventions

saxagliptin

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Eric Grouzmann, Dr

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of laboratory

Model Details: double-blind placebo-controlled crossover study

Study Record Dates

• First Submitted: April 19, 2019
• First Posted: May 1, 2019
• Study Start: June 5, 2018
• Primary Completion: July 18, 2018
• Study Completion: April 15, 2019
• Last Updated: May 1, 2019

Record last verified: 2019-04

Locations

CH (1)