NCT06051097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

September 4, 2023

Last Update Submit

September 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

OSA with metabolic syndrome

sleep study

Diagnostic Test: sleep study

OSA without metabolic syndrome

sleep study

Diagnostic Test: sleep study

Interventions

sleep studyDIAGNOSTIC_TEST

over-night polysomnography

OSA with metabolic syndromeOSA without metabolic syndrome

Eligibility Criteria

Age22 Years - 77 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • Cerebro-vascular accident within the preceding 30 days.
  • Patients on sedatives.
  • Patients on anti-psychotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr alainy school of medicine

Cairo, 11562, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sampling for lipid profile and HBAIC

MeSH Terms

Conditions

Sleep Apnea SyndromesMetabolic Syndrome

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of pulmonology

Study Record Dates

First Submitted

September 4, 2023

First Posted

September 22, 2023

Study Start

September 1, 2022

Primary Completion

March 31, 2023

Study Completion

May 15, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations