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出境医 / 临床实验 / Neuropeptide Y and Sympathovagal Balance (NPY)

Neuropeptide Y and Sympathovagal Balance (NPY)

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 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.
Study Design
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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
Arms and Interventions
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
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 ]
    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]


Eligibility Criteria
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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
Contacts and Locations

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
Layout table for investigator information
Principal Investigator: Eric Grouzmann, Dr Centre Hospitalier Universitaire Vaudois
Tracking Information
First Submitted Date  ICMJE April 19, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date May 1, 2019
Actual Study Start Date  ICMJE June 5, 2018
Actual Primary Completion Date July 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • 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
  • Heart rate change variability assessed at the end of each exercise [ Time Frame: 5 hours and 30 minutes ]
    normalized low frequency (nLF) measurement
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • NPY 1-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    half-life [t1/2]
  • NPY 1-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Area under the plasma concentration versus time curve [AUC]
  • NPY 1-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Peak Plasma Concentration [Cmax]
  • NPY 3-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Half-life [t1/2]
  • NPY3-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Area under the plasma concentration versus time curve [AUC]
  • NPY3-36 secretion [ Time Frame: 5 hours and 30 minutes ]
    Peak Plasma Concentration [Cmax]
  • Catecholamine secretion [ Time Frame: 5 hours and 30 minutes ]
    Half-life [t1/2]
  • Catecholamine secretion [ Time Frame: 5 hours and 30 minutes ]
    Area under the plasma concentration versus time curve [AUC]
  • Catecholamine secretion [ Time Frame: 5 hours and 30 minutes ]
    Peak Plasma Concentration [Cmax]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuropeptide Y and Sympathovagal Balance
Official Title  ICMJE Neuropeptide Y Function in the Sympathovagal Balance During an Ergometric Test in Healthy Volunteers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Physical Activity
  • Sympathetic Nervous System
  • Secretion; Catecholamine
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Placebo oral capsule
    • Other: ergometric test in healthy volunteers
  • 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
    Interventions:
    • Drug: Saxagliptin 5mg
    • Other: ergometric test in healthy volunteers
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2019) 		7
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 15, 2019
Actual Primary Completion Date July 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 24 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03933787
Other Study ID Numbers  ICMJE 2018-00569
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: all IPD that underlie results in a publication
Responsible Party Eric Grouzmann, Centre Hospitalier Universitaire Vaudois
Study Sponsor  ICMJE Eric Grouzmann
Collaborators  ICMJE
  • grégoire wuerzner
  • grégoire millet
  • Nicolas Bourdillon
  • Philippe Eugster
Investigators  ICMJE
Principal Investigator: Eric Grouzmann, Dr Centre Hospitalier Universitaire Vaudois
PRS Account Centre Hospitalier Universitaire Vaudois
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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