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

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive; Myocardial Dysfunction; Diabetes Mellitus, Type 2; Echocardiography; Continuous Positive Airway Pressure; Obesity
• Interventions: Device: Sham CPAP; Device: Therapeutic CPAP

• Registration Number: NCT03221205
• Lead Sponsor: Instituto Nacional de Enfermedades Respiratorias

Brief 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.

Study Timeline

• Study Start: 2014-10-15
• Study First Submitted: 2017-07-14
• Study First Submitted QC: 2017-07-17
• Study First Posted: 2017-07-18
• Primary Completion: 2017-10-24
• Study Completion: 2017-11-24
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham CPAP	Sham CPAP	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.
Therapeutic CPAP	Therapeutic CPAP	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.

Primary Outcome Measures

Name	Time	Method
TEI index	After 3 months of CPAP use.	Cardiac performance, evaluated through TEI index.
Strain	After 3 months of CPAP use.	Cardiac performance, evaluated through echocardiographic strain.

Secondary Outcome Measures

Name	Time	Method
Mean value of arterial pressure	After 3 months of CPAP use	Mean value of systolic and diastolic arterial pressure, as measured through an ambulatory monitoring of arterial pressure for 24 hours.
Apnea hypopnea index	After 3 months CPAP use.	Number of events of apnea and hypopnea per hour of sleep, evaluated through an type 3 overnight sleep study,
Mean oxygen saturation	After 3 months of CPAP use.	Mean value of the data of oxygen saturation reported in a type 3 overnight sleep study.
Highest CO2	After three months CPAP use	Highest reported value of carbon dioxide during a night of sleep, as measured via transcutaneous capnography in an overnight sleep study.
Time of saturation under 90%.	After 3 months CPAP use	Percent of the time of duration of a type three overnight sleep study in which the SO2 was under 90%.
Hemoglobin A1C	After three months of CPAP use.	Glycemic control via hemoglobin A1C, percent.
Plasma glucose.	After 3 months of CPAP use.	Levels of glucose in plasma, in mg/dL.
Time of hypercapnia	After three months CPAP use.	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.
Mean CO2	After three months CPAP use	Mean of the values of carbon dioxide during a night of sleep, as measured via transcutaneous capnography in an overnight sleep study.

Trial Locations

Locations (1)

Insituto Nacional de Enfermedades Respiratorias; 🇲🇽 Mexico City, Delegacion Tlalpan, Mexico