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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Obstructive Sleep Apnea

Intervention / Treatment
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* Diagnostic Test: polysomnography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases DR<br>diabetic patients with diabetic retinopathy (DR) | Diagnostic Test: polysomnography<br>* classical polysomnography non invasive measurement of blood pressure blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes<br>* Other names: blood test;|
| Cases other<br>diabetic patiens with other/multiple ocular disorder(s) | Diagnostic Test: polysomnography<br>* classical polysomnography non invasive measurement of blood pressure blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes<br>* Other names: blood test;|
| Control<br>diabetic patients without ocular abnormalities | Diagnostic Test: polysomnography<br>* classical polysomnography non invasive measurement of blood pressure blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes<br>* Other names: blood test;|

What is the study measuring?
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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 | obstructive sleep apnea is defined as apnea-hypopnea index > 15 on polysomnography | 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic retinopathy, diabetes, arterial hypertension, obstructive sleep apnea syndrome