CPAP Effect on Albuminuria in Patients With Diabetic Nephropathy and Obstructive Sleep Apnea
Condition: Diabetic Nephropathy; Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Kidney Diseases; Diabetic Nephropathies; Albuminuria
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): Continuous positive airway pressure; Pharmacological treatment; Diet
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 angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists or anti-aldosterone agents.; Conventional anti-diabetic diet recommendations
Other intervention name(s): Conventional pharmacological treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPAP; Sleep apnea; Diabetes; Nephropathy; Albuminuria