Effect of CPAP on Myocardial Dysfunction in Type 2 Diabetes Mellitus and Obstructive Sleep Apnea Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Nasal CPAP on Myocardial Dysfunction and Glycemic Control in Patients With Type 2 Diabetes, Obstructive Sleep Apnea and Obesity

Conditions
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Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2, Continuous Positive Airway Pressure, Echocardiography, Myocardial Dysfunction, Obesity

Intervention / Treatment
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* Device: Sham CPAP
* Device: Therapeutic CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical data of obstructive sleep apnea: snoring, witnessed apneas, excessive daytime somnolence. Previous diagnosis of type 2 diabetes mellitus, with medical treatment according to the ADA 2012 guidelines, but only with one of the next drugs: biguanides, sulphonylurea, meglitinide, thiazolidinedione, alpha-glucosidase inhibitors. Obesity, defined by a body mass index higher than 29 kilogram per square meter. Exclusion Criteria: Type 1 diabetes mellitus. Insulin dependent type 2 diabetes mellitus Fasting plasma glucose higher than 212 mg/dL . Antecedent of myocardial infarction, heart failure or arrhythmia. Obstructive sleep apnea in treatment. Urgent need of CPAP treatment (public transport drivers, heavy machine operators).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham CPAP<br>Patients randomized to use sham CPAP via a nasal mask every night for three months, also with medical treatment for control of obesity, optimal medical treatment for diabetes mellitus. | Device: Sham CPAP<br>* 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.<br>|
| Experimental: Therapeutic CPAP<br>Patients randomized to use CPAP programmed to administer automatically pressure from 4 to 20 cm H2O via a nasal mask every night for three months, also with medical treatment for control of obesity, optimal medical treatment for diabetes mellitus. | Device: Therapeutic CPAP<br>* Use of CPAP (ResMed AutoSet S9 with humidifier) through nasal mask and tube with automatized pressure from 4 to 20 cmH2O.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEI index | Cardiac performance, evaluated through TEI index. | After 3 months of CPAP use. | 
| Strain | Cardiac performance, evaluated through echocardiographic strain. | After 3 months of CPAP use. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C | Glycemic control via hemoglobin A1C, percent. | After three months of CPAP use. | 
| Plasma glucose. | Levels of glucose in plasma, in mg/dL. | 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, | After 3 months CPAP use. | 
| Mean oxygen saturation | Mean value of the data of oxygen saturation reported in a type 3 overnight sleep study. | 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. | 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. | 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. | 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. | 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%. | 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. | After 3 months of CPAP use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, obstructive, DM2, TEI index, CPAP, obesity