Adropin In Patients of OSANCT07829809
Serum Adropin as an Indicator of Endothelial Dysfunction and Disease Severity in Obstructive Sleep Apnea in Obese Patients
An observational study of Adropin In Patients of OSA, run by Aswan University.
Trial summary
1. Objectives (Aim): To evaluate the role of serum adropin as a potential biomarker of endothelial dysfunction in OSA 1. Compare serum adropin levels between Obese patients with and without OSA. 2. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Adropin In Patients of OSA
- What is being tested?
- Adropin
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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
Who may be able to join
- 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
Who cannot join
- 1-Pregnant females 2-Thyroid disorders 3-Autoimmune diseases 4-chronic liver disease 5-chronic kidney disease 6-drugs as statin,glucocorticoids and antidepressant
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- 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.
Read the detailed description
- 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.
- Conditions
- Adropin In Patients of OSA
- Being tested
- Adropin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdropinDiagnostic test
Fasting blood samples of Adropin were obtained by venipuncture in the morning following the sleep study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum adropin levels (measured by ELISA)
- Serum adropin levels (measured by ELISA)
- Association between serum adropin and endothelial function (Endothelin -1).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adropin In Patients of OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Mohamed Yusuf, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829809
- Sponsor's protocol ID
- Serum Adropin and OSA
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Altamimi TR, Gao S, Karwi QG, Fukushima A, Rawat S, Wagg CS, Zhang L, Lopaschuk GD. Adropin regulates cardiac energy metabolism and improves cardiac function and efficiency. Metabolism. 2019 Sep;98:37-48. doi: 10.1016/j.metabol.2019.06.005. Epub 2019 Jun 14.
PubMed 31202835
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Adropin as an Indicator of Endothelial Dysfunction and Disease Severity in Obstructive Sleep Apnea in Obese Patients
- ClinicalTrials.gov ID
- NCT07829809
- Acronym / sponsor ID
- Serum Adropin and OSA
- Conditions
- Adropin In Patients of OSA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed description
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 1-Pregnant females 2-Thyroid disorders 3-Autoimmune diseases 4-chronic liver disease 5-chronic kidney disease 6-drugs as statin,glucocorticoids and antidepressant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdropinFasting blood samples of Adropin were obtained by venipuncture in the morning following the sleep study. | Diagnostic test | – |
Primary outcome
Serum adropin levels (measured by ELISA)
Time frame: 12 months
* Serum adropin levels (measured by ELISA) * Association between serum adropin and endothelial function (Endothelin -1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Results publication: PubMed 31202835Altamimi TR, Gao S, Karwi QG, Fukushima A, Rawat S, Wagg CS, Zhang L, Lopaschuk GD. Adropin regulates cardiac energy metabolism and improves cardiac function and efficiency. Metabolism. 2019 Sep;98:37-48. doi: 10.1016/j.metabol.2019.06.005. Epub 2019 Jun 14.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Adropin In Patients of OSA, run by Aswan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Mohamed Yusuf, Demonstrator (20+01273966368, esraayusuf5050@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum adropin levels (measured by ELISA) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07829809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.