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

NCT03314467 | Completed

• 1 other identifier: BE76201733442
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Obstructive Sleep Apnea

Keywords

diabetic retinopathy; diabetes; arterial hypertension; obstructive sleep apnea syndrome

Outcome Measures

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

  1 month

Secondary Outcomes (1)

• Correlation between severity of obstructive sleep apnea and presence of diabetic retinopathy

  1 month

Study Arms (3)

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

polysomnography DIAGNOSTIC_TEST

* 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

Cases DR; Cases other; Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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..

You may qualify if:

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

You may not qualify if:

• known presence of obstructive sleep apnea and treated by CPAP

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

Centre Hospitalier Universitaire Saint Pièrre

Brussels, Belgium

Location

Related 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.

  PMID: 28594570 BACKGROUND

• 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.

  PMID: 28429032 BACKGROUND

• 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.

  PMID: 27990441 BACKGROUND

• 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.

  PMID: 28562529 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

bloodserum

MeSH Terms

Conditions

Diabetes Mellitus; Sleep Apnea, Obstructive; Diabetic Retinopathy; Hypertension

Interventions

Polysomnography; Arterial Pressure; Hematologic Tests

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Blood Pressure; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Marie Bruyneel, MD, PhD

  Centre hospitalier universitaire St Pièrre - Pneumologie/Labo du sommeil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chef de clinique

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 19, 2017
• Study Start: October 6, 2017
• Primary Completion: March 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)