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

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 30, 2020

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

Arms, Groups and Cohorts

  • Cases DR
    • diabetic patients with diabetic retinopathy (DR)
  • Cases other
    • diabetic patiens with other/multiple ocular disorder(s)
  • Control
    • diabetic patients without ocular abnormalities

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Correlation between severity of obstructive sleep apnea and presence of diabetic retinopathy
    • Time Frame: 1 month

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire Saint Pierre
  • Provider of Information About this Clinical Study
    • Principal Investigator: Marie Bruyneel, Chef de clinique – Centre Hospitalier Universitaire Saint Pierre
  • Overall Official(s)
    • Marie Bruyneel, MD, PhD, Principal Investigator, Centre hospitalier universitaire St Pièrre – Pneumologie/Labo du sommeil
  • Overall Contact(s)
    • Marie Bruyneel, MD, PhD, +3225354203, marie_bruyneel@stpierre-bru.be

References

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. Epub 2016 Nov 21. Review.

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.

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