Role of Obstructive Sleep Apnea Syndrome in the Occurrence of Diabetic Retinopathy in Type 2 Diabetes.
NCT ID: NCT03314467
Last Updated: 2021-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2017-10-06
2021-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cases DR
diabetic patients with diabetic retinopathy (DR)
polysomnography
* classical polysomnography
* non invasive measurement of blood pressure
* blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes
Cases other
diabetic patiens with other/multiple ocular disorder(s)
polysomnography
* classical polysomnography
* non invasive measurement of blood pressure
* blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes
Control
diabetic patients without ocular abnormalities
polysomnography
* classical polysomnography
* non invasive measurement of blood pressure
* blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes
Interventions
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polysomnography
* classical polysomnography
* non invasive measurement of blood pressure
* blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* able to undergo an in-lab polysomnography
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Saint Pierre
OTHER
Responsible Party
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Marie Bruyneel
Chef de clinique
Principal Investigators
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Marie Bruyneel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre hospitalier universitaire St Pièrre - Pneumologie/Labo du sommeil
Locations
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Centre Hospitalier Universitaire Saint Pièrre
Brussels, , Belgium
Countries
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References
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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.
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.
Vujosevic S, Midena E. Diabetic Retinopathy in Italy: Epidemiology Data and Telemedicine Screening Programs. J Diabetes Res. 2016;2016:3627465. doi: 10.1155/2016/3627465. Epub 2016 Nov 21.
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.
Other Identifiers
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BE76201733442
Identifier Type: -
Identifier Source: org_study_id
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