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Metabolic Syndrome and Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT06051097
Recruitment Status : Completed
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
Eman Kamal Ibrahim Hassan, Cairo University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.


Condition or disease Intervention/treatment
Sleep Apnea Metabolic Syndrome Diagnostic Test: sleep study

Study Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Relationship Between Metabolic Syndrome and Obstructive Sleep Apnea
Actual Study Start Date : September 1, 2022
Actual Primary Completion Date : March 31, 2023
Actual Study Completion Date : May 15, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
OSA with metabolic syndrome
sleep study
 Diagnostic Test: sleep study
over-night polysomnography
OSA without metabolic syndrome
sleep study
 Diagnostic Test: sleep study
over-night polysomnography


Outcome Measures
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Primary Outcome Measures :
  1. Predictors of metabolic syndrome among OSA patients [ Time Frame: 6 months ]
    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)


Biospecimen Retention:   Samples Without DNA
blood sampling for lipid profile and HBAIC

Eligibility Criteria
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Ages Eligible for Study:   22 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study was conducted in the pulmonology department at kasrelainy hospital.Itincluded 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
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051097


Locations
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Egypt
Kasr alainy school of medicine
Cairo, Egypt, 11562
Sponsors and Collaborators
Cairo University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Eman Kamal Ibrahim Hassan, Assistant Professor of pulmonology, Cairo University
ClinicalTrials.gov Identifier: NCT06051097    
Other Study ID Numbers: MS-258-2022
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases