Evaluation of Prolidase in Obstructive Sleep Apnea Syndrome

Obstructive Sleep-Apnea Syndrome Clinical Trial

Official title:

Evaluation of Prolidase as an Oxidative Stress Marker in Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03563118
• Other study ID #: OSAS
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: June 2018
• Source: Sakarya University
• Contact: Havva Sayhan
• Phone: +905056621021
• Email: hsayhan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Obstructive sleep apnea (OSA) is a highly prevalent breathing disorder in sleep. We have aimed to evaluate the relationship between OSA and prolidase activity, the oxidative stress index (OSI), total antioxidative capacity (TAC), and total oxidative capacity (TOC) and the relationship between carotid intima media thickness (CIMT).

Description:

This study was approved by the local ethics committee in accordance with the Helsinki Declaration. Written informed consent was received from the OSAS Subjects patients and control subjects before enrolment in the study. The patient and control cohorts were recruited from the Pulmonary Medicine Department, Medical Faculty, Yuzuncu Yıl University. Blood samples were analysed at the Biochemistry Laboratory of Harran University Medical Faculty TAC and TOS levels were measured by using an automated measurement method. TAC measurement method involves the production of a potent biological hydroxyl radical. Ferrous ion solution is mixed with hydrogen peroxide. Thus, it is possible to measure the anti-oxidative effect of the sample against the potent free radical reactions initiated by the production of the hydroxyl radical. TOS method is based on the oxidation of ferrous ion to ferric ion in the presence of various oxidant species in acidic medium and the measurement of the ferric ion by xylenol orange. mmol Trolox equivalent (equiv)/L, mmol H2O2 /L and mg/dL, respectively.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: December 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients were diagnosed with OSA after night polysomnography (PSG).

• Patients were enrolled in the study following receipt of their written informed consent.

Exclusion Criteria:

• Patients had ischaemic cardiovascular diseases,

• Patients had chronic obstructive pulmonary diseases,

• Patients had ischaemic cerebral diseases,

• Patients had chronic inflammatory diseases,

• Patients had chronic and acute systemic infections.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep-Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Locations

Country	Name	City	State
Turkey	Sakarya University Research and Training Hospital	Sakarya	Merkez
Turkey	Sakarya University Research and Training Hospital	Sakarya

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Yamauchi M, Nakano H, Maekawa J, Okamoto Y, Ohnishi Y, Suzuki T, Kimura H. Oxidative stress in obstructive sleep apnea. Chest. 2005 May;127(5):1674-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolidase activity	Prolidase activity was determined by a photometric method based on the measurement of the proline levels produced by prolidase (26). Plasma samples (100ml) were blended with 100 ml of serum physiological. A total of 25 ml of the mixture was preincubated with 75ml of the preincubation solution (50 mmol/l Tris HCl buffer pH 7.0 containing 1mmol/l glutathion, 50mmol/l MnCl2) at 37°C for 30min.	1 month