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

C

Centre Hospitalier Universitaire Saint Pierre

Status

Completed

Conditions

Diabetes Mellitus
Obstructive Sleep Apnea

Treatments

Diagnostic Test: polysomnography

Study type

Observational

Funder types

Other

Identifiers

NCT03314467
BE76201733442

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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

Trial design

60 participants in 3 patient groups

Cases DR
Description:
diabetic patients with diabetic retinopathy (DR)
Treatment:
Diagnostic Test: polysomnography
Cases other
Description:
diabetic patiens with other/multiple ocular disorder(s)
Treatment:
Diagnostic Test: polysomnography
Control
Description:
diabetic patients without ocular abnormalities
Treatment:
Diagnostic Test: polysomnography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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