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

National Institute of Respiratory Diseases (INER)

Status: Completed

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

Treatments: Device: Sham CPAP; Device: Therapeutic CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT03221205

C_30-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups

Sham CPAP

Sham Comparator group

Description:

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.

Treatment:

Device: Sham CPAP

Therapeutic CPAP

Experimental group

Description:

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.

Treatment:

Device: Therapeutic CPAP