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Neuropeptide Y and Sympathovagal Balance (NPY)

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ClinicalTrials.gov Identifier: NCT03933787
Recruitment Status : Completed
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborators:
grégoire wuerzner
grégoire millet
Nicolas Bourdillon
Philippe Eugster
Information provided by (Responsible Party):
Eric Grouzmann, Centre Hospitalier Universitaire Vaudois

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 Intervention/treatment Phase
Physical Activity Sympathetic Nervous System Secretion; Catecholamine Drug: Saxagliptin 5mg Drug: Placebo oral capsule Other: ergometric test in healthy volunteers 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.

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Study Type : Interventional  (Clinical Trial)
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)
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
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 5, 2018
Actual Primary Completion Date : July 18, 2018
Actual Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Saxagliptin

Arm Intervention/treatment
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

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




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 ]
    half-life [t1/2]

  2. NPY 1-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Area under the plasma concentration versus time curve [AUC]

  3. NPY 1-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Peak Plasma Concentration [Cmax]

  4. NPY 3-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Half-life [t1/2]

  5. NPY3-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Area under the plasma concentration versus time curve [AUC]

  6. NPY3-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Peak Plasma Concentration [Cmax]

  7. Catecholamine secretion [ Time Frame: 5 hours and 30 minutes ]
    Half-life [t1/2]

  8. Catecholamine secretion [ Time Frame: 5 hours and 30 minutes ]
    Area under the plasma concentration versus time curve [AUC]

  9. Catecholamine secretion [ Time Frame: 5 hours and 30 minutes ]
    Peak Plasma Concentration [Cmax]



Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933787


Locations
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Switzerland
Service de Néphrologie
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Eric Grouzmann
grégoire wuerzner
grégoire millet
Nicolas Bourdillon
Philippe Eugster
Investigators
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Principal Investigator: Eric Grouzmann, Dr Centre Hospitalier Universitaire Vaudois
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Responsible Party: Eric Grouzmann, Head of laboratory, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT03933787    
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

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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.: No
Keywords provided by Eric Grouzmann, Centre Hospitalier Universitaire Vaudois:
neuropeptide Y,catecholamine, exercise
Additional relevant MeSH terms:
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Saxagliptin
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents