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

Completed

• Conditions: Obstructive Sleep Apnea; Diabetes Mellitus
• Interventions: Diagnostic Test: polysomnography

• Registration Number: NCT03314467
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief Summary

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

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 Timeline

• Study Start: 2017-10-06
• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-19
• Primary Completion: 2021-03-30
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases other	polysomnography	diabetic patiens with other/multiple ocular disorder(s)
Cases DR	polysomnography	diabetic patients with diabetic retinopathy (DR)
Control	polysomnography	diabetic patients without ocular abnormalities

Primary Outcome Measures

Name	Time	Method
Presence of obstructive sleep apnea in diabetic patients is a predictive factor for diabetic retinopathy occurence	1 month	obstructive sleep apnea is defined as apnea-hypopnea index \> 15 on polysomnography

Secondary Outcome Measures

Name	Time	Method
Correlation between severity of obstructive sleep apnea and presence of diabetic retinopathy	1 month

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Saint Pièrre; 🇧🇪 Brussels, Belgium