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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06051097
Other study ID # MS-258-2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date May 15, 2023

Study information

Verified date September 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background:Metabolic syndrome is a disorder characterized by abdominal obesity,hypertension,increased triglycerides ,decreased HDL cholesterol and increased blood glucose. Accumulating evidence strongly indicates that insulin resistance and an increased amount of abdominal fat are the pathogenic factors for the characteristics of metabolic syndrome. Studies indicate that sleep apnea may be a manifestation of the metabolic syndrome. Subjects and methods:This study was conducted in the pulmonology department at kasrelainy hospital. It included 80 patients who came to the sleep lab unit for polysomnography. Each patient was subjected to full history taking including(sex,age,smoking history,presence of diabetes or hypertension),thorough clinical examination with emphasis on waist, neck&hip circumference and blood pressure measurements,Laboratory investigations including :Lipid profile& Diabetic profile(HBA1C).In addition to ESS and stop bang score questionnaire.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 15, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers No
Gender All
Age group 22 Years to 77 Years
Eligibility Inclusion Criteria: - Patients fulfilled the criteria of OSA ( obstructive sleep apnea) in the form of symptoms suggestive of OSA (daytime sleepiness/daytime fatigue/headache/snoring)and with AHI ( apnea-hyponea index) =5. Exclusion Criteria: 1. Cerebro-vascular accident within the preceding 30 days. 2. Patients on sedatives. 3. Patients on anti-psychotics

Study Design


Intervention

Diagnostic Test:
sleep study
over-night polysomnography

Locations

Country Name City State
Egypt Kasr alainy school of medicine Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Predictors of metabolic syndrome among OSA patients evaluation of factors related to occurrence of metabolic syndrome in OSA such as age(in years),weight in kilograms(kg) and height in meters (m) will not be measured separately but combined to assess BMI( weight in kg/ height in m2) and oxygen saturation (O2%), evaluation of polysomnographic data and laboratory tests in the form of lipid profile in (mg/dl) and HBA1C (g/dl) 6 months
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