CPAP Effect on the Progression of Diabetic Retinopathy in Patients With Sleep Apnea
Condition: Diabetic Retinopathy; Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): Continuous positive airway pressure; Pharmacological treatment; Conventional anti-diabetic diet recommendations
Intervention type(s): Device; Drug; Other
Intervention description(s): Nocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed).; Conventional pharmacological treatment with oral antidiabetic drugs or insulin
Intervention MeSH terms: Hypoglycemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPAP; Sleep apnea; Diabetes; Diabetic retinopathy