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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Neuropeptide Y and Sympathovagal Balance

Clinicaltrials.gov identifier NCT03933787

Recruitment Status Completed

First Posted May 1, 2019

Last update posted May 1, 2019

Study Description

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).

  • Condition or Disease:Physical Activity
    Sympathetic Nervous System
    Secretion; Catecholamine
  • Intervention/Treatment: Drug: Saxagliptin 5mg
    Drug: Placebo oral capsule
    Other: ergometric test in healthy volunteers
  • Phase: Early Phase 1
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.

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 7 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Intervention Model Description: double-blind placebo-controlled crossover study
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Basic Science
  • Official Title: Neuropeptide Y Function in the Sympathovagal Balance During an Ergometric Test in Healthy Volunteers
  • Actual Study Start Date: June 2018
  • Actual Primary Completion Date: July 2018
  • Actual Study Completion Date: April 2019
Arms and interventions
Arm Intervention/treatment
Active Comparator: Saxagliptin in a tablet
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
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
Placebo Comparator: mannitol in a tablet
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
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
Outcome Measures
  • Primary Outcome Measures: 1. Heart rate change variability assessed at the end of each exercise [ Time Frame: 5 hours and 30 minutes ]
    RMSSD (Root mean square of successive RR interval differences) measurement
  • 2. Heart rate change variability assessed at the end of each exercise [ Time Frame: 5 hours and 30 minutes ]
    normalized low frequency (nLF) measurement
  • Secondary Outcome Measures: 1. NPY 1-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Peak Plasma Concentration [Cmax]
  • 2. NPY 3-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Half-life [t1/2]
  • 3. NPY3-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Area under the plasma concentration versus time curve [AUC]
  • 4. NPY3-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Peak Plasma Concentration [Cmax]
  • 5. Catecholamine secretion [ Time Frame: 5 hours and 30 minutes ]
    Half-life [t1/2]
  • 6. Catecholamine secretion [ Time Frame: 5 hours and 30 minutes ]
    Area under the plasma concentration versus time curve [AUC]
  • 7. Catecholamine secretion [ Time Frame: 5 hours and 30 minutes ]
    Peak Plasma Concentration [Cmax]
  • 8. NPY 1-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    half-life [t1/2]
  • 9. NPY 1-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Area under the plasma concentration versus time curve [AUC]
Eligibility Criteria
  • Ages Eligible for Study: 24 to 30 Years (Adult)
  • Sexes Eligible for Study: Male
  • Accepts Healthy Volunteers: Yes
Criteria

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

Contacts and Locations
Contacts
Locations

Switzerland, Vaud
Service de Néphrologie
Lausanne

Sponsors and Collaborators

Eric Grouzmann

grégoire wuerzner

grégoire millet

Nicolas Bourdillon

Philippe Eugster

Investigators

Principal Investigator: Eric Grouzmann, Dr Centre Hospitalier Universitaire Vaudois

More Information
  • Responsible Party: Eric Grouzmann
  • ClinicalTrials.gov Identifier: NCT03933787 History of Changes
  • Other Study ID Numbers: 2018-00569
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: May 1, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Plan Description: all IPD that underlie results in a publication
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Eric Grouzmann: neuropeptide Y,catecholamine, exercise