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

February 15, 2022 updated by: Amr Shoukri, Ain Shams University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11341
        • Ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients 18 years old or above, with type 2 diabetes.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between nocturnal oxygen desaturation and glycemic control
Time Frame: 1 year
measurements of blood glucose control and nocturnal oxygen level.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2020

Primary Completion (Actual)

October 20, 2021

Study Completion (Actual)

October 20, 2021

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 15, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPO10-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

results of noxturnal oximetry, patients demographics.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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