- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07829809
Serum Adropin as an Indicator of Endothelial Dysfunction and Disease Severity in Obstructive Sleep Apnea in Obese Patients
1. Objectives (Aim): To evaluate the role of serum adropin as a potential biomarker of endothelial dysfunction in OSA
- Compare serum adropin levels between Obese patients with and without OSA.
- Correlate serum adropin with OSA severity indices including the Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) and cardiovascular complications.
- Assess the relationship between serum adropin and endothelial dysfunction markers (endothelin-1).
- Evaluate adropin's predictive ability for endothelial impairment among OSA patients.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
1. Background and Rationale ( Introduction): Obstructive Sleep Apnea (OSA) is a common sleep-related breathing disorder characterized by recurrent episodes of partial or complete upper airway obstruction during sleep, resulting in intermittent hypoxia, sleep fragmentation, and increased sympathetic nervous system activity. These pathophysiological disturbances promote oxidative stress and systemic inflammation, which contribute to vascular injury and increase cardiovascular risk in patients with OSA (Li et al., 2020). Intermittent hypoxia has been shown to induce endothelial oxidative stress and inflammatory signaling in a dose-dependent manner, with greater severity of OSA being associated with more pronounced vascular dysfunction (Ryan et al., 2021).
Endothelial dysfunction is considered a key early mechanism linking OSA to cardiovascular disease. Intermittent hypoxia impairs endothelial homeostasis mainly through reduced nitric oxide (NO) bioavailability, increased endothelin-1 activity, and activation of pro-inflammatory pathways, leading to abnormal vascular tone and progression of atherosclerosis and hypertension (Javaheri and Barbe, 2020). Importantly, endothelial dysfunction may precede overt cardiovascular disease, highlighting its value as an early therapeutic target in OSA patients.
Identifying early biomarkers of endothelial dysfunction in OSA is therefore of major clinical importance for risk stratification and prevention of cardiovascular complications. Such biomarkers may also help in monitoring disease severity and evaluating response to therapeutic interventions, including continuous positive airway pressure therapy (Ryan et al., 2021).
Adropin is a peptide hormone encoded by the ENHO gene and is involved in energy homeostasis, lipid metabolism, and endothelial function. It enhances endothelial nitric oxide synthase activity and NO production, exerting protective effects on the vascular endothelium. Experimental and clinical studies have demonstrated that reduced circulating adropin levels are associated with endothelial dysfunction, insulin resistance, and increased cardiovascular risk (Altamimi et al., 2021).
Recent studies have demonstrated significantly lower serum adropin levels in patients with obstructive sleep apnea compared to healthy controls, with negative correlations between adropin levels and apnea-hypopnea index severity, as well as positive associations with endothelial function markers (Yosaee et al., 2020; Aşkın et al., 2022). Given the central role of endothelial dysfunction in OSA-related cardiovascular morbidity and the vasoprotective properties of adropin, evaluating serum adropin levels may represent a simple and reliable marker of endothelial dysfunction in patients with obstructive sleep apnea.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Esraa Mohamed Yusuf, Demonstrator
- Telefonnummer: 20+01273966368
- E-mail: esraayusuf5050@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
The study will include adult obese participants who are referred to the Sleep Medicine/Chest outpatient clinic with suspected obstructive sleep apnea. Participants will undergo clinical assessment and overnight polysomnography (PSG) to confirm the diagnosis of OSA and determine its severity according to the apnea-hypopnea index (AHI).
Participants will be categorized into appropriate study groups according to the presence and severity of OSA. A suitable comparison group of obese participants without OSA may also be included, according to the study design.
The study population will include both males and females who meet the predefined inclusion criteria and provide informed consent to participate in the study
Beskrivelse
Inclusion Criteria:
-
1- Adults aged 20-75 years. 2-obese Patients diagnosed with obstructive sleep apnea (OSA) confirmed by polysomnography.
3- Patients willing to provide written informed consent. 4- Patients not currently on medications affecting endothelial function (e.g., statins, ACE inhibitors) or able to temporarily withhold under medical supervision.
5- Ability to comply with study procedures and follow-up
Exclusion Criteria:
- 1-Pregnant females 2-Thyroid disorders 3-Autoimmune diseases 4-chronic liver disease 5-chronic kidney disease 6-drugs as statin,glucocorticoids and antidepressant
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiver: RETROSPECTIVE
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum adropin levels (measured by ELISA)
Tidsramme: 12 months
|
|
12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Serum Adropin and OSA
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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