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

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ClinicalTrials.gov Identifier: NCT03314467
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre

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.


Condition or disease Intervention/treatment
Diabetes Mellitus Obstructive Sleep Apnea Diagnostic Test: polysomnography

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of Obstructive Sleep Apnea Syndrome in the Occurrence of Diabetic Retinopathy in Type 2 Diabetes.
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases DR
diabetic patients with diabetic retinopathy (DR)
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
Other Names:
  • arterial tension
  • blood test

Cases other
diabetic patiens with other/multiple ocular disorder(s)
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
Other Names:
  • arterial tension
  • blood test

Control
diabetic patients without ocular abnormalities
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
Other Names:
  • arterial tension
  • blood test




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Correlation between severity of obstructive sleep apnea and presence of diabetic retinopathy [ Time Frame: 1 month ]

Biospecimen Retention:   Samples Without DNA
bloodserum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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..
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03314467


Contacts
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Contact: Marie Bruyneel, MD, PhD +3225354203 marie_bruyneel@stpierre-bru.be
Contact: Pham Anh Hong Nguyen, MD pham_nguyen@stpierre-bru.be

Locations
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Belgium
Centre Hospitalier Universitaire Saint Pièrre Recruiting
Brussels, Belgium
Contact: Marie Bruyneel, MD, PhD       marie_bruyneel@stpierre-bru.be   
Contact: Pham Anh Hong Nguyen, MD       pham_nguyen@stpierre-bru.be   
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
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Principal Investigator: Marie Bruyneel, MD, PhD Centre hospitalier universitaire St Pièrre - Pneumologie/Labo du sommeil

Publications:
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Responsible Party: Marie Bruyneel, Chef de clinique, Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT03314467     History of Changes
Other Study ID Numbers: BE76201733442
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre:
diabetic retinopathy
diabetes
arterial hypertension
obstructive sleep apnea syndrome

Additional relevant MeSH terms:
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Diabetes Mellitus
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Retinal Diseases
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications