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NCT03314467 Clinical Trial

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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03314467
Other study ID # BE76201733442
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 6, 2017
Est. completion date June 30, 2021

Study information
Verified date September 2021
Source Centre Hospitalier Universitaire Saint Pierre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date June 30, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium Centre Hospitalier Universitaire Saint Pièrre Brussels

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

Altaf QA, Dodson P, Ali A, Raymond NT, Wharton H, Fellows H, Hampshire-Bancroft R, Shah M, Shepherd E, Miah J, Barnett AH, Tahrani AA. Obstructive Sleep Apnea and Retinopathy in Patients with Type 2 Diabetes. A Longitudinal Study. Am J Respir Crit Care Med. 2017 Oct 1;196(7):892-900. doi: 10.1164/rccm.201701-0175OC. — View Citation

Mok Y, Tan CW, Wong HS, How CH, Tan KL, Hsu PP. Obstructive sleep apnoea and Type 2 diabetes mellitus: are they connected? Singapore Med J. 2017 Apr;58(4):179-183. doi: 10.11622/smedj.2017027. — View Citation

Vujosevic S, Midena E. Diabetic Retinopathy in Italy: Epidemiology Data and Telemedicine Screening Programs. J Diabetes Res. 2016;2016:3627465. Epub 2016 Nov 21. Review. — View Citation

Zhou Y, Zhang Y, Shi K, Wang C. Body mass index and risk of diabetic retinopathy: A meta-analysis and systematic review. Medicine (Baltimore). 2017 Jun;96(22):e6754. doi: 10.1097/MD.0000000000006754. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Correlation between severity of obstructive sleep apnea and presence of diabetic retinopathy 1 month
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