PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea

Inflammation Clinical Trial

— MacroSAS  

Official title:

PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235023
• Other study ID #: 49RC19-0226
• Status: Completed
• Phase: N/A
• Start date: February 4, 2020
• Est. completion date: February 3, 2022

Study information

• Verified date: June 2024
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 3, 2022
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Atherosclerosis
• Inflammation
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• myeloid PTP1B expression analysis
peripheral blood macrophage PTP1B expression

Locations

Country	Name	City	State
France	Angers University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Primary	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.	baseline
Secondary	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.	baseline
Secondary	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.	baseline