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

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.

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Key information

Conditions

Diabetes Mellitus Apnea Cardiovascular Diseases Diabetes Complications Diabetic Angiopathies Diabetic Retinopathy Dyssomnias Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Retinal Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire Saint Pièrre

Brussels, Belgium

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Diagnostic Test

classical polysomnography
non invasive measurement of blood pressure
blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes

Other names: arterial tension, blood test

Primary outcomes

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

Secondary outcomes

Correlation between severity of obstructive sleep apnea and presence of diabetic retinopathy

Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Oct 19, 2017
Registry last updated: Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed