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CompletedNCT03314467Updated Sep 2, 2021

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

An observational study in Diabetes Mellitus and Obstructive Sleep Apnea, sponsored by Centre Hospitalier Universitaire Saint Pierre. Completed at 1 site in Belgium. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-09-02.

Sponsored by Centre Hospitalier Universitaire Saint Pierre · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus
  • Obstructive Sleep Apnea

Keywords

  • diabetic retinopathy
  • diabetes
  • arterial hypertension
  • obstructive sleep apnea syndrome
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with a diagnosis of diabetes type I or type II who went to a ocular screening visit to assess ocular complications associated with diabetes are asked to undergo an in-lab polysomnography..

Inclusion criteria

  • presence of diabetic type II
  • able to undergo an in-lab polysomnography

Exclusion criteria

Exclusion Criteria:

  • known presence of obstructive sleep apnea and treated by CPAP
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Cases DR

    diabetic patients with diabetic retinopathy (DR)

    Diagnostic Test: polysomnography

  • Cases other

    diabetic patiens with other/multiple ocular disorder(s)

    Diagnostic Test: polysomnography

  • Control

    diabetic patients without ocular abnormalities

    Diagnostic Test: polysomnography

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

    Also known as: arterial tension, blood test

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 month

Secondary outcomes

  1. Correlation between severity of obstructive sleep apnea and presence of diabetic retinopathy

    Time frame: 1 month

06

Study locations

1 site
  • Centre Hospitalier Universitaire Saint Pièrre
    Brussels, Belgium
07

References and documents

Publications

  • 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. PubMed 28594570 ↗
  • 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. PubMed 28429032 ↗
  • 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. PubMed 27990441 ↗
  • 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. PubMed 28562529 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03314467
Lead sponsor
Centre Hospitalier Universitaire Saint Pierre
Responsible party
Marie Bruyneel (Chef de clinique, Centre Hospitalier Universitaire Saint Pierre) — Principal investigator
First posted
Oct 19, 2017
Start date
Oct 6, 2017
Primary completion
Mar 30, 2021
Completion
Jun 30, 2021
Last update
Sep 2, 2021

Study contacts

Marie Bruyneel, MD, PhD
principal investigator · Centre hospitalier universitaire St Pièrre - Pneumologie/Labo du sommeil

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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