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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
78
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.
Insituto Nacional de Enfermedades Respiratorias
Mexico City, Delegacion Tlalpan, Mexico
TEI index
Cardiac performance, evaluated through TEI index.
Time frame: After 3 months of CPAP use.
Strain
Cardiac performance, evaluated through echocardiographic strain.
Time frame: After 3 months of CPAP use.
Hemoglobin A1C
Glycemic control via hemoglobin A1C, percent.
Time frame: After three months of CPAP use.
Plasma glucose.
Levels of glucose in plasma, in mg/dL.
Time frame: After 3 months of CPAP use.
Apnea hypopnea index
Number of events of apnea and hypopnea per hour of sleep, evaluated through an type 3 overnight sleep study,
Time frame: After 3 months CPAP use.
Mean oxygen saturation
Mean value of the data of oxygen saturation reported in a type 3 overnight sleep study.
Time frame: After 3 months of CPAP use.
Time of hypercapnia
Number of minutes per night of sleep in which the carbon dioxide value was above 45 mmHg, as measured via transcutaneous capnography in an overnight sleep study.
Time frame: After 3 months of CPAP use.
Time of hypercapnia
Number of minutes per night of sleep in which the carbon dioxide value was above 45 mmHg, as measured via transcutaneous capnography in an overnight sleep study.
Time frame: After three months CPAP use.
Mean CO2
Mean of the values of carbon dioxide during a night of sleep, as measured via transcutaneous capnography in an overnight sleep study.
Time frame: After three months CPAP use
Highest CO2
Highest reported value of carbon dioxide during a night of sleep, as measured via transcutaneous capnography in an overnight sleep study.
Time frame: After three months CPAP use
Time of saturation under 90%.
Percent of the time of duration of a type three overnight sleep study in which the SO2 was under 90%.
Time frame: After 3 months CPAP use
Mean value of arterial pressure
Mean value of systolic and diastolic arterial pressure, as measured through an ambulatory monitoring of arterial pressure for 24 hours.
Time frame: After 3 months of CPAP use
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