CPAP Effect on Albuminuria in Patients With Diabetic Nephropathy and Obstructive Sleep Apnea
Status:
Completed
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
Objectives: Main objective: To assess the effect of 12 months of CPAP treatment added to
conventional drug treatment on the albuminuria in patients with diabetic nephropathy and
obstructive sleep apnea (OSA). Secondary objectives: To evaluate the effect of CPAP treatment
on the estimated glomerular filtration rate of patients with diabetic nephropathy and OSA;
determine the additional longterm CPAP effect on glycemic control, insulin resistance, lipid
profile, health-related quality of life and biomarkers of cardiac function, inflammation,
oxidative stress, sympathetic tone and appetite-regulating hormones in patients with diabetic
nephropathy and OSA; and to identify the subgroup of patients with diabetic nephropathy and
OSA in which 12 months of treatment with CPAP achieve a more pronounced reduction in
albuminuria.
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 18 to 80 years with overweight or obesity and a clinical diagnosis of
diabetic nephropathy, increased urinary albumin/creatinine ratio of 30 mg/g and an estimated
glomerular filtration rate >20 ml/min/1.73 m2, and treatment with stable doses of
angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) or
anti-aldosterone drugs in the last four weeks. Efficacy variables:
urinary albumin/creatinine ratio and estimated glomerular filtration rate; glycosylated
hemoglobin (HbA1c); fasting glucose and insulin; homeostatic model assessment (HOMA) and
QUICKI indices; total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides; Troponin
I, proBNP, homocysteine and high-sensitivity C-reactive protein; systemic biomarkers
(inflammation [IL-6, IL-8 and tumor necrosis factor-α], oxidative stress [8-isoprostane],
endothelial damage [endothelin, VCAM-1 and ICAM-1], sympathetic activity [neuropeptide Y] and
appetite-regulating hormones [leptin and adiponectin]) and clinical questionnaires: short
form (SF)-12, EuroQoL and iPAQ.