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NCT Number: NCT04235023

PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea

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.

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Key information

Conditions

Sleep Apnea Apnea Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dyssomnias Inflammation Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angers University Hospital

Angers, 49100, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

myeloid PTP1B expression analysis

Other

peripheral blood macrophage PTP1B expression

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. PTP1B exosomal expression.

    Time frame: baseline

    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.

  2. in vitro PTP1B implication on macrophage inflammatory response

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: MacroSAS

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 21, 2020
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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