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PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea (MacroSAS)

Primary Purpose

Sleep Apnea, Inflammation, Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
myeloid PTP1B expression analysis
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sleep Apnea focused on measuring PTP1B, macrophage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • past history of cardiovascular diseases
  • diabetes
  • dyslipidemia
  • hypertension
  • obesity (body mass index > 35 kg/m2
  • past history or ongoing inflammatory diseases
  • cognition impairment

Sites / Locations

  • Angers University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

OSA patients

non OSA patients

Arm Description

30 patients investigated for suspected OSA with an apnea hypopnea index ≥ 15 per hour

30 patients investigated for suspected OSA with an apnea hypopnea index < 15 per hour

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 7, 2020
Last Updated
February 9, 2023
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04235023
Brief Title
PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea
Acronym
MacroSAS
Official Title
PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
February 3, 2022 (Actual)
Study Completion Date
February 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Inflammation, Atherosclerosis
Keywords
PTP1B, macrophage

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OSA patients
Arm Type
Other
Arm Description
30 patients investigated for suspected OSA with an apnea hypopnea index ≥ 15 per hour
Arm Title
non OSA patients
Arm Type
Other
Arm Description
30 patients investigated for suspected OSA with an apnea hypopnea index < 15 per hour
Intervention Type
Other
Intervention Name(s)
myeloid PTP1B expression analysis
Intervention Description
peripheral blood macrophage PTP1B expression
Primary Outcome Measure Information:
Title
myeloid PTP1B expression
Description
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.
Time Frame
baseline
Title
myeloid PTP1B activity
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
PTP1B exosomal expression.
Description
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.
Time Frame
baseline
Title
in vitro PTP1B implication on macrophage inflammatory response
Description
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.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: past history of cardiovascular diseases diabetes dyslipidemia hypertension obesity (body mass index > 35 kg/m2 past history or ongoing inflammatory diseases cognition impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wojciech Trzepizur, MD Ph D
Organizational Affiliation
Angers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Angers University Hospital
City
Angers
ZIP/Postal Code
49100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea

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