Effect of CPAP on Myocardial Dysfunction in Type 2 Diabetes Mellitus and Obstructive Sleep Apnea Patients
Condition: Sleep Apnea, Obstructive; Diabetes Mellitus, Type 2; Continuous Positive Airway Pressure; Myocardial Dysfunction; Echocardiography; Obesity
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study evaluates the effect of the use of nasal CPAP in the cardiac function, measured by
      strain and TEI index, in patients with type 2 diabetes mellitus, obstructive sleep apnea and
      obesity. In order to do so, 76 patients will be studied, half will use sham CPAP and half
      will use therapeutic CPAP for three months, with echocardiogram, laboratory studies,
      ambulatory monitoring of arterial tension and sleep study before and after CPAP use.
    

Detailed description: 
      The obstructive sleep apnea syndrome (OSAS) is a disease characterized by repeated episodes
      of partial of total obstruction of the upper airway during sleep. It affects 3.2% of adults
      in Mexico City. These patients have a higher risk of suffering traffic accidents,
      cardiovascular diseases, a lower quality of life and premature death. The association between
      OSAS and heart failure is complex, but it is known that they have a higher risk of myocardial
      dysfunction with OR 2.4 (IC 95% 1.2 - 4.6), with higher mortality against controls. Type 2
      diabetes mellitus (DM2) is a chronic metabolic disease that leads to macro and micro vascular
      damage, and is the first cause of mortality in Mexico (13.8% of all deaths in people older
      than 20 years). Its general prevalence in adults is of 7%. There is a strong association
      between OSAS, insulin resistance and DM2, with studies with 86% of patients with DM2 having
      some degree of sleep apnea reported, with 22.6% having severe OSAS. The presence of DM2
      doubles the risk of cardiovascular disease in men and triples it in women, with coronary
      cardiac disease being the main cause of death. Patients with OSAS have altered myocardial
      function even in asymptomatic state, also patients with DM2 have been shown to have
      abnormalities in myocardial function, myocardial performance and myocardial elongation in
      comparison with a control group. There is no current information about the effect of
      treatment with CPAP on myocardial performance of patients with OSAS, DM2 and obesity.
    

Intervention name(s): Sham CPAP; Therapeutic CPAP
Intervention type(s): Device; Device
Intervention description(s): CPAP (ResMed AutoSet S9 with humidifier) to be used by the participant via nasal mask and tube, programmed to apply 0.5 cmH2O (measured at the nasal mask) via a resistance to assure the lack of distal pressure.; Use of CPAP (ResMed AutoSet S9 with humidifier) through nasal mask and tube with automatized pressure from 4 to 20 cmH2O.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sleep apnea, obstructive; obesity; DM2; TEI index; CPAP