Evaluation of Prolidase in Obstructive Sleep Apnea Syndrome

Sponsor

Sakarya University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03563118

Collaborator

(none)

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep-Apnea Syndrome

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

74 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Group OSAS We included 56 with OSAS [13 subjects 23.2% mild, 19 subjects 33.9% moderate, 24 subjects 42.8% severe
control group simple snoring

Outcome Measures

Primary Outcome Measures

Prolidase activity [1 month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients were diagnosed with OSA after night polysomnography (PSG).
Patients were enrolled in the study following receipt of their written informed consent.