Introduction: Although the evidence is scarce and heterogeneous, there are data supporting a possible role of continuous positive airway pressure therapy (CPAP) in reducing albuminuria in patients with obstructive sleep apnea (OSA) and diabetic kidney disease (DKD). Our objective was to evaluate, through a randomized clinical trial, the effect of CPAP treatment for 12 months on the urinary albumin-to-creatinine ratio in urine in patients with OSA and DKD. Methods: A 12-month open-label, parallel, and randomized clinical trial was conducted with 185 patients with OSA (apnea-hypopnea index ≥ 10) and DKD. Randomized patients were assigned at a table 1:1 ratio, stratified by albuminuria severity (30-300 mg/g and ≥300 mg/g), to receive CPAP therapy (n = 93) or no CPAP (n = 92). Their usual pharmacological treatment remained unchanged during follow-up. . The albumin-to-creatinine ratio and other biochemical parameters such as HbA1C, insulin resistance index or serum creatinine, anthropometric characteristics, sleepiness, health-related quality of life and physical activity questionnaires, as well as adherence to CPAP, were assessed at 3, 6 and 12 months of follow-up. Results: Twelve months of CPAP therapy did not reduce albuminuria in the intention-to-treat analysis. However, a reduction in albuminuria was observed in patients with good CPAP adherence compared to the control group. CPAP treatment also improved glycemic control and insulin resistance, as well as sleepiness and health-related quality of life. Subjects with more severe OSA disease, a lower degree of somnolence, moderate-to-severe DKD and a more recent diagnosis of DKD, as well as those with autonomic diabetic neuropathy, experienced a more pronounced reduction in albuminuria secondary to CPAP treatment. Conclusions: In patients with OSA and DKD, good adherence to CPAP treatment for 12 months succeeded in significantly reducing albuminuria compared to a control group
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