Physical ActivityEarly Phase 1NPYNCT03933787
Neuropeptide Y and Sympathovagal Balance
A Early Phase 1 study testing Saxagliptin 5mg and ergometric test in healthy volunteers in people with Physical Activity and Sympathetic Nervous System, run by Eric Grouzmann at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 24 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Sympathetic Nervous System, Secretion; Catecholamine
- What is being tested?
- Saxagliptin 5mg and ergometric test in healthy volunteers
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Jun 2018to 15 Apr 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuropeptide Y Function in the Sympathovagal Balance During an Ergometric Test in Healthy Volunteers
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).
Read the 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.
- Being tested
- Saxagliptin 5mg, Placebo oral capsule, ergometric test in healthy volunteers
- Keywords
- neuropeptide Y,catecholamine, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saxagliptin 5mgDrug
Randomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin
Placebo oral capsuleDrug
Randomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin
ergometric test in healthy volunteersOther
The volunteers will undergo an ergometric test in each session
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Saxagliptin 5mg; Other: ergometric test in healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate change variability assessed at the end of each exercise
RMSSD (Root mean square of successive RR interval differences) measurement
Measured: 5 hours and 30 minutes
Heart rate change variability assessed at the end of each exercise
normalized low frequency (nLF) measurement
Measured: 5 hours and 30 minutes
Secondary outcomes (9)
NPY 1-36 secretion
half-life [t1/2]
Measured: 5 hours and 30 minutes
NPY 1-36 secretion
Area under the plasma concentration versus time curve [AUC]
Measured: 5 hours and 30 minutes
NPY 1-36 secretion
Peak Plasma Concentration [Cmax]
Measured: 5 hours and 30 minutes
NPY 3-36 secretion
Half-life [t1/2]
Measured: 5 hours and 30 minutes
NPY3-36 secretion
Area under the plasma concentration versus time curve [AUC]
Measured: 5 hours and 30 minutes
NPY3-36 secretion
Peak Plasma Concentration [Cmax]
Measured: 5 hours and 30 minutes
Catecholamine secretion
Half-life [t1/2]
Measured: 5 hours and 30 minutes
Catecholamine secretion
Area under the plasma concentration versus time curve [AUC]
Measured: 5 hours and 30 minutes
Catecholamine secretion
Peak Plasma Concentration [Cmax]
Measured: 5 hours and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start5 Jun 2018
- Primary completion18 Jul 2018
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double-blind placebo-controlled crossover study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Grouzmann
- Sponsor type
- University, hospital or other
- Collaborators
- grégoire wuerzner, grégoire millet, Nicolas Bourdillon, Philippe Eugster
- Responsible party
- Sponsor-investigator, Eric Grouzmann, Centre Hospitalier Universitaire Vaudois
- Investigators
- Eric Grouzmann, Dr, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03933787
- Sponsor's protocol ID
- 2018-00569
- Other IDs
- 2018
- Acronym
- NPY
- Status last verified
- Apr 2019
- First submitted
- 19 Apr 2019
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropeptide Y Function in the Sympathovagal Balance During an Ergometric Test in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03933787
- Acronym / sponsor ID
- NPY / 2018-00569
- Keywords
- neuropeptide Y,catecholamine, exercise
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Eric GrouzmannUniversity, hospital or other
- Collaborators
- grégoire wuerzner, grégoire millet, Nicolas Bourdillon, Philippe Eugster
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind placebo-controlled crossover study
| Arm | Type | Receives |
|---|---|---|
| mannitol in a tablet | Placebo comparator | Drug: Placebo oral capsule, Other: ergometric test in healthy volunteerstwo 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 |
| Saxagliptin in a tablet | Active comparator | Drug: Saxagliptin 5mg, Other: ergometric test in healthy volunteerstwo 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 |
Who may qualify
- Ages
- 24 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saxagliptin 5mgRandomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin | Drug | Saxagliptin in a tablet |
| Placebo oral capsuleRandomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin | Drug | mannitol in a tablet |
| ergometric test in healthy volunteersThe volunteers will undergo an ergometric test in each session | Other | Saxagliptin in a tablet, mannitol in a tablet |
Primary outcome
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
9 secondary outcomes
NPY 1-36 secretion
Time frame: 5 hours and 30 minutes
NPY 1-36 secretion
Time frame: 5 hours and 30 minutes
NPY 1-36 secretion
Time frame: 5 hours and 30 minutes
NPY 3-36 secretion
Time frame: 5 hours and 30 minutes
NPY3-36 secretion
Time frame: 5 hours and 30 minutes
NPY3-36 secretion
Time frame: 5 hours and 30 minutes
Catecholamine secretion
Time frame: 5 hours and 30 minutes
Catecholamine secretion
Time frame: 5 hours and 30 minutes
Catecholamine secretion
Time frame: 5 hours and 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Individual participant dataSharing planned: Undecided. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Grouzmann, Dr principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Saxagliptin 5mg and ergometric test in healthy volunteers in people with Physical Activity and Sympathetic Nervous System, run by Eric Grouzmann at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate change variability assessed at the end of each exercise (time frame: 5 hours and 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.