Evaluation of Prolidase in Obstructive Sleep Apnea Syndrome

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

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).

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 74

Contacts and Locations

• Study Contact: Name: Havva Sayhan; Phone Number: +905056621021; Email: hsayhan@gmail.com
• Study Contact Backup: Name: hulya gunbatar, asso. prof.; Phone Number: +905065118827; Email: hulyagunbatar@gmail.com

Study Locations

• Turkey
  • Sakarya, Turkey, 54100
    • Recruiting
    • Sakarya University Research and Training hospital
    • Contact: Havva Sayhan, Assis Prof; Phone Number: +905056621021; Email: hsayhan@gmail.com
    • Contact: müge yılmaz
  • Merkez
    • Sakarya, Merkez, Turkey, 54100
      • Recruiting
      • Sakarya University Research and Training hospital
      • Contact: Havva Sayhan, Assis Prof; Phone Number: +905056621021; Email: hsayhan@gmail.com
      • Contact: hulya gunbatar, assosiate. prof.; Phone Number: +905065118827; Email: hulyagunbatar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient (male/female: 43/31) were diagnosed with OSA after night polysomnography (PSG)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sakarya University
• Investigators: Study Chair: Havva Sayhan, Sakarya University Research and Training hospital

Publications and helpful links

General Publications

• 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. doi: 10.1378/chest.127.5.1674.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: June 7, 2018
• First Submitted That Met QC Criteria: June 19, 2018
• First Posted (Actual): June 20, 2018

Study Record Updates

• Last Update Posted (Actual): June 20, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Prolidase Activity; Obstructive Sleep-Apnea Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: OSAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No