Obstructive Sleep Apnea and Diabetic Macular Edema Inflammatory Mediators

NCT04648618 | Unknown

• 1 other identifier: OSA-DME 2
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is characterized by intermittent nocturnal hypoxemia, frequent arousals, fragmented sleep and daytime sleepiness. It has been shown to increase the risk of cardiac and vascular disease through multiple mechanisms including sympathetic hyperactivity, metabolic dysregulation, and activation of oxidative stress and inflammatory pathways. Diabetic retinopathy is a leading cause of blindness in the working age group, affecting 93 million people worldwide. Diabetic macular edema (DME) is a sight threatening complication and the most common cause of visual loss in patients with diabetes. OSA is frequently associated with diabetes with prevalence ranging from 23 to 86%. However, the relationship between OSA and DME is not well defined. The retina is especially susceptible to hypoxia, being one of the most metabolically active tissues. Many of the same inflammatory mediators have also been found to be elevated in patients with diabetic macular edema, including VEGF, VCAM-1 and IL-6. There has been no previous study examining the biochemical impact of OSA on patients with DME. We aim to explore this relationship by examining the differences in inflammatory markers expressed in patients with DME who have undergone an overnight sleep study, which is considered the gold standard diagnostic tool in OSA.

Conditions

Diabetic Macular Edema; Obstructive Sleep Apnea; Diabetic Retinopathy

Keywords

diabetic macular edema; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• Cytokines

  Level of cytokines between patients with and without OSA

  Jan 2018- Mar 2020

Study Arms (2)

OSA + DME +

Patients with OSA and DME

OSA - DME +

Patients with DME, but no evidence of OSA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Type I/II diabetic patients with diabetic macular edema undergoing first intravitreal injection.

You may qualify if:

• Type I/II diabetic patients with evidence of diabetic macular edema requiring treatment with anti-VEGF

You may not qualify if:

• Contraindications to intravitreal injection including stroke within the past month, ocular or peri-ocular infection, active intraocular inflammation, hypersensitivity to components of the intra-vitreal injection
• Any other retinal or macular pathology such as retinal detachment and age related macular degeneration
• Patients that have taken any systemic immunosuppressive or anti-inflammatory within the past 30 days
• Impaired mental capacity to comply (eg. dementia)
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Uptown Eye Specialists: lead

Study Sites (1)

Uptown Eye Speicialists

Brampton, Ontario, L6Y0P6, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

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; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 1, 2020
• Study Start: January 1, 2018
• Primary Completion: March 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

CA (1)