Role of Obstructive Sleep Apnea Syndrome in the Occurrence of Diabetic Retinopathy in Type 2 Diabetes.

September 1, 2021 updated by: Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre

Diabetic retinopathy (DR) is the most common visual complication of diabetes. Risk factors for developing DR are diabetes duration, glycemic control, and hypertension . The prevalence ranges from 17 to 61% according to the diabetes duration .

Obstructive sleep apnea syndrome (OSAS) is very frequent in Type 2 Diabetes population, reaching a prevalence of 23-48% .

Few is known about the exact role of OSAS in the development of DR. A recent study has shown that OSAS is an independent predictor for the progression to pre-/proliferative DR. The purpose of the present study is to assess if the presence of OSA in diabetic patients is a predictive factor for DR occurrence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetic retinopathy (DR) is the most common visual complication of diabetes. Risk factors for developing DR are diabetes duration, glycemic control, and hypertension. The prevalence ranges from 17 to 61% according to the diabetes duration.

Obstructive sleep apnea syndrome (OSAS) is very frequent in Type 2 Diabetes population, reaching a prevalence of 23-48%.

Few is known about the exact role of OSAS in the development of DR. A recent study has shown that OSAS is an independent predictor for the progression to pre-/proliferative DR. The purpose of the present study is to assess if the presence of OSA in diabetic patients is a predictive factor for DR occurrence.

Study Type

Observational

Enrollment (Actual)

60

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

  • Belgium
      • Brussels, Belgium
        • Centre Hospitalier Universitaire Saint Pierre

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with a diagnosis of diabetes type I or type II who went to a ocular screening visit to assess ocular complications associated with diabetes are asked to undergo an in-lab polysomnography..

Description

Inclusion Criteria:

  • presence of diabetic type II
  • able to undergo an in-lab polysomnography

Exclusion Criteria:

  • known presence of obstructive sleep apnea and treated by CPAP

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases DR
diabetic patients with diabetic retinopathy (DR)
Diagnostic test: polysomnography
  • classical polysomnography
  • non invasive measurement of blood pressure
  • blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes
Other Names:
  • blood test
  • arterial tension
Cases other
diabetic patiens with other/multiple ocular disorder(s)
Diagnostic test: polysomnography
  • classical polysomnography
  • non invasive measurement of blood pressure
  • blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes
Other Names:
  • blood test
  • arterial tension
Control
diabetic patients without ocular abnormalities
Diagnostic test: polysomnography
  • classical polysomnography
  • non invasive measurement of blood pressure
  • blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes
Other Names:
  • blood test
  • arterial tension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of obstructive sleep apnea in diabetic patients is a predictive factor for diabetic retinopathy occurence
Time Frame: 1 month
obstructive sleep apnea is defined as apnea-hypopnea index > 15 on polysomnography
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between severity of obstructive sleep apnea and presence of diabetic retinopathy
Time Frame: 1 month
1 month

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Investigators

  • Principal Investigator: Marie Bruyneel, MD, PhD, Centre hospitalier universitaire St Pièrre - Pneumologie/Labo du sommeil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 6, 2017

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

September 2, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE76201733442

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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