Correlation Between Nocturnal Oxygen Desaturation and Glycemic Control in Diabetic Patients With Obstructive Sleep Apnea

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT04711083
Collaborator
(none)
107
1
18
5.9

Study Details

Study Description

Brief Summary

Nocturnal reduction in blood oxygen is expected independently associated with the development of worsened glycemic control in individuals with type 2 diabetes mellitus.

The aim of the present study is to assess the correlation between nocturnal oxygen desaturation assessed by overnight pulse oximetry and glycemic control in diabetic patients with obstructive sleep apnea.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: overnight pulse oximetry

Detailed Description

Introduction:

Obstructive sleep apnea syndrome (OSAS) is a prevalent illness showing a heterogeneous symptom presentation, which ranges from low clinical suspicion to evident limitations in the quality of life. The main reasons for this variability relate to its potential association with major concomitant diseases, which include diabetes and a variety of cardiovascular pathologies. (1).

Also, OSA is a known risk factor for many comorbid disorders, causing resistance to conventional treatments and increasing the risk of mortality, which multiplies health care expenditures and even though the distribution of comorbidities differs between men and women, their effect progressively increases with OSA severity (2,3) Occurrence of apneic events and Reduction in blood oxygen and elevations in blood carbon dioxide are sensed by chemoreceptors in the brain and carotid bodies, which trigger brief microarousals and result in sleep fragmentation (4).

Nocturnal reduction in blood oxygen has also been independently associated with the development of worsened glycemic control in individuals with type 2 diabetes (4).

Aim of the work:

to assess the correlation between nocturnal oxygen desaturation assessed by overnight pulse oximetry and glycemic control in diabetic patients with obstructive sleep apnea.

Material and Methods:

This study will be conducted on all patients referred for evaluation of sleep related breathing disorders. All Medical files were reviewed. Data collected included .full medical history, demographics, measurements of weight and height, body mass index in kg/m2, neck circumference (NC), Epworth Sleepiness Scale (ESS) scores, measurements of overnight pulse oximetryglyceminc control (measurement of glycated HB, fasting and 2h postprandial blood sugar)The diagnosis that was concluded after a polysomnography study.

Study Design

Study Type:
Observational
Actual Enrollment :
107 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Correlation Between Nocturnal Oxygen Desaturation and Glycemic Control in Diabetic Patients With Obstructive Sleep Apnea
Actual Study Start Date :
Apr 20, 2020
Actual Primary Completion Date :
Oct 20, 2021
Actual Study Completion Date :
Oct 20, 2021

Outcome Measures

Primary Outcome Measures

  1. correlation between nocturnal oxygen desaturation and glycemic control [1 year]

    measurements of blood glucose control and nocturnal oxygen level.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • All patient swith type 2 diabetes, referred for evaluation of sleep related breathing disorder
Exclusion Criteria:
  • Patients less than 18 years old and Patients receiving treatment for sleep related breathing disorders were excluded

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain Shams University Cairo Egypt 11341

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amr Shoukri, Assistant Professor of pulmonary medicine, Ain Shams University
ClinicalTrials.gov Identifier:
NCT04711083
Other Study ID Numbers:
  • OPO10-18
First Posted:
Jan 15, 2021
Last Update Posted:
Feb 16, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2022