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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03314467

Enrollment

Registered

2017-10-19

Start date

2017-10-06

Completion date

2021-06-30

Last updated

2021-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Obstructive Sleep Apnea

Keywords

diabetic retinopathy, diabetes, arterial hypertension, obstructive sleep apnea syndrome

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.

Interventions

DIAGNOSTIC_TESTpolysomnography

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Correlation between severity of obstructive sleep apnea and presence of diabetic retinopathy	1 month

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026