CPAP Effect on the Progression of Diabetic Retinopathy in Patients With Sleep Apnea
Status:
Completed
Trial end date:
2021-03-01
Target enrollment:
Participant gender:
Summary
Objectives: Main objective: To compare the percentage of patients with new microaneurysm or
hard exudates after 12 months between the CPAP group and the control group. Secondary
objectives: To compare the central macula volume, ganglion cell layer thickness and central
fovea thickness at baseline and 12, 24 and 52 weeks after randomization between the two study
groups; to compare the percentage of patients who have an improvement loss of visual acuity
(more than or equal to 15 letters in patients with macular edema and more than or equal to
five letters in patients without macular edema) among the baseline visit and the weeks 12, 24
and 52 between the two study groups; to compare the percentage of patients who reach a higher
level of diabetic retinopathy at 54 weeks between the two study groups; to compare the
resolution time of central macula thickness from the randomization between the two study
groups; to compare the glycated hemoglobin at baseline and 12, 24 and 52 weeks after
randomization between the two study groups; and to compare the serum levels of inflammatory
cytokines, oxidative stress biomarkers, sympathetic tone, and intake regulator hormones at
baseline and 12 and 52 weeks after randomization between the two study groups.
Methodology: Randomized, multicenter, non-blinded, parallel groups, conventional
treatment-controlled trial of 12 months of duration.
Subjects will randomize to conventional dietary and pharmacological treatment or conventional
dietary and pharmacological treatment plus continuous positive airway pressure (CPAP). Study
subjects: Subjects 35 to 75 years with type 2 diabetes and a clinical diagnosis of mild
diabetic retinopathy (with or without macular edema), better visual acuity from 20/40 to
20/320 letters and refraction with a spherical equivalent less than ± 5 diopter.
Efficacy variables: Thickness of the central sub-field, central subfield volume, ganglion
cell layer thickness, and presence of clinical or subclinical macular edema, serous retinal
or retinal pigment epithelium detachment, intraretinal cysts or haemorrhages assessed by
optical coherence tomography; presence of cotton exudates, microhemorrhages, microaneurysms,
, microvascular retinal abnormalities, or a vein/artery ratio > 2/1 in examination of ocular
fundus/retinography; better corrected visual acuity; glycosylated hemoglobin (HbA1c); fasting
glucose and insulin; homeostatic model assessment (HOMA) and QUICKI indices; lipid profile,
troponin I, proBNP, homocysteine and C-reactive protein; systemic biomarkers of inflammation,
oxidative stress, endothelial damage, sympathetic activity and appetite-regulating hormones
and clinical questionnaires: short form (SF)-12, visual function questionnaire (VFQ25) and
iPAQ.