PTP1B Implication in the Vascular Dysfunction Associated With Obstructive Sleep Apnea

NCT04235023 | Completed

• 1 other identifier: 49RC19-0226
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea; Inflammation; Atherosclerosis

Keywords

PTP1B; macrophage

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• PTP1B exosomal expression.

  baseline

• in vitro PTP1B implication on macrophage inflammatory response

  baseline

Study Arms (2)

OSA patients

OTHER

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

Other: myeloid PTP1B expression analysis

non OSA patients

OTHER

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

Other: myeloid PTP1B expression analysis

Interventions

myeloid PTP1B expression analysis OTHER

peripheral blood macrophage PTP1B expression

OSA patients; non OSA patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Angers University Hospital

Angers, 49100, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Inflammation; Atherosclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Wojciech Trzepizur, MD Ph D

  Angers University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: patients with OSA 'apnea hypopnea index ≥ 15 per hour) as compared to controls (an apnea hypopnea index \< 15 per hour)

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 21, 2020
• Study Start: February 4, 2020
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

FR (1)