Sleep ApneaMacroSASNCT04235023
PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea
A study testing myeloid PTP1B expression analysis in people with Sleep Apnea and Inflammation, run by University Hospital, Angers at 1 site in France.
Trial summary
Obstructive sleep apnea (OSA) syndrome is associated with increased vascular dysfunction and atherosclerosis. Especially, it has been shown that OSA associated intermittent hypoxia represents a pro inflammatory stimulus resulting in macrophage polarization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Inflammation, Atherosclerosis
- What is being tested?
- myeloid PTP1B expression analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2020to 3 Feb 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overnight polysomnographic recording for suspected OSA
- Apnea hypopnea index ≥ 15 per hour for OSA patients
- Apnea hypopnea index < 15 per hour for non OSA patients
Who cannot join
- past history of cardiovascular diseases
- diabetes
- dyslipidemia
- hypertension
- obesity (body mass index > 35 kg/m2
- past history or ongoing inflammatory diseases
- cognition impairment
Trial locations and contacts
1 site in 1 country.
About this study
Obstructive sleep apnea (OSA) syndrome is associated with increased vascular dysfunction and atherosclerosis. Especially, it has been shown that OSA associated intermittent hypoxia represents a pro inflammatory stimulus resulting in macrophage polarization.
Protein tyrosine phosphatase 1B (PTP1B) is a negative regulator of insulin signaling pathways involved in atherosclerosis. It has been shown that myeloid PTP1B deficiency protects against atherosclerosis.
As hypoxia has also been shown to increase PTP1B expression and activity, this study will evaluate the myeloid PTP1B expression and activity in patients with OSA as compared to controls and will investigate myeloid PTP1B involvement in the vascular pro inflammatory precess described in OSA.
- Conditions
- Sleep Apnea, Inflammation, Atherosclerosis
- Being tested
- myeloid PTP1B expression analysis
- Keywords
- PTP1B, macrophage
- Medical subject headings
- Sleep Apnea Syndromes, Inflammation, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myeloid PTP1B expression analysisOther
peripheral blood macrophage PTP1B expression
| Study group | Role | What they receive |
|---|---|---|
| OSA patients | Other | 30 patients investigated for suspected OSA with an apnea hypopnea index ≥ 15 per hour Receives: Other: myeloid PTP1B expression analysis |
| non OSA patients | Other | 30 patients investigated for suspected OSA with an apnea hypopnea index < 15 per hour Receives: Other: myeloid PTP1B expression analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
myeloid PTP1B expression
Peripheral blood will be collected from OSA and non OSA patients. Macrophage will be isolated by specific centrifugation. PTP1B expression will be assessed by Western Blot.
Measured: baseline
myeloid PTP1B activity
Peripheral blood will be collected from OSA and non OSA patients. Macrophage will be isolated by specific centrifugation. PTP1B activity will be assessed by specific colorimetric assay.
Measured: baseline
Secondary outcomes (2)
PTP1B exosomal expression.
Peripheral blood will be collected from OSA and non OSA patients. Exosomes will be isolated by consecutive centrifugations. PTP1B expression will be assessed by Western Blot.
Measured: baseline
in vitro PTP1B implication on macrophage inflammatory response
Macrophage isolated from patients will be stimulated by pro inflammatory agents (IL6, TNF alpha) in the presence and absence of PTP1B inhibitor (MSI-1436). The inflammatory response will be assessed by measuring inflammatory cytokines in the supernatant by ELISA.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start4 Feb 2020
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- patients with OSA 'apnea hypopnea index ≥ 15 per hour) as compared to controls (an apnea hypopnea index \< 15 per hour)
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Wojciech Trzepizur, MD Ph D, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235023
- Sponsor's protocol ID
- 49RC19-0226
- Acronym
- MacroSAS
- Status last verified
- Jun 2024
- First submitted
- 7 Jan 2020
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04235023
- Acronym / sponsor ID
- MacroSAS / 49RC19-0226
- Conditions
- Sleep Apnea, Inflammation, Atherosclerosis
- Keywords
- PTP1B, macrophage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 21 Jan 2020 (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.
Obstructive sleep apnea (OSA) syndrome is associated with increased vascular dysfunction and atherosclerosis. Especially, it has been shown that OSA associated intermittent hypoxia represents a pro inflammatory stimulus resulting in macrophage polarization.
Protein tyrosine phosphatase 1B (PTP1B) is a negative regulator of insulin signaling pathways involved in atherosclerosis. It has been shown that myeloid PTP1B deficiency protects against atherosclerosis.
As hypoxia has also been shown to increase PTP1B expression and activity, this study will evaluate the myeloid PTP1B expression and activity in patients with OSA as compared to controls and will investigate myeloid PTP1B involvement in the vascular pro inflammatory precess described in OSA.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients with OSA 'apnea hypopnea index ≥ 15 per hour) as compared to controls (an apnea hypopnea index < 15 per hour)
| Arm | Type | Receives |
|---|---|---|
| OSA patients | Other | Other: myeloid PTP1B expression analysis30 patients investigated for suspected OSA with an apnea hypopnea index ≥ 15 per hour |
| non OSA patients | Other | Other: myeloid PTP1B expression analysis30 patients investigated for suspected OSA with an apnea hypopnea index < 15 per hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overnight polysomnographic recording for suspected OSA
- Apnea hypopnea index ≥ 15 per hour for OSA patients
- Apnea hypopnea index < 15 per hour for non OSA patients
Key exclusion criteria (7 listed)
- past history of cardiovascular diseases
- diabetes
- dyslipidemia
- hypertension
- obesity (body mass index > 35 kg/m2
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 |
|---|---|---|
| myeloid PTP1B expression analysisperipheral blood macrophage PTP1B expression | Other | OSA patients, non OSA patients |
Primary outcome
myeloid PTP1B expression
Time frame: baseline
Peripheral blood will be collected from OSA and non OSA patients. Macrophage will be isolated by specific centrifugation. PTP1B expression will be assessed by Western Blot.
myeloid PTP1B activity
Time frame: baseline
Peripheral blood will be collected from OSA and non OSA patients. Macrophage will be isolated by specific centrifugation. PTP1B activity will be assessed by specific colorimetric assay.
2 secondary outcomes
PTP1B exosomal expression.
Time frame: baseline
in vitro PTP1B implication on macrophage inflammatory response
Time frame: baseline
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 11 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Wojciech Trzepizur, MD Ph D principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myeloid PTP1B expression analysis in people with Sleep Apnea and Inflammation, run by University Hospital, Angers at 1 site in France.
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 3 inclusion and 7 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 11 Jun 2024. 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
myeloid PTP1B expression (time frame: baseline). 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 11 Jun 2024.