Effect of Nasal CPAP on Myocardial Dysfunction and Glycemic Control in Patients With Type 2 Diabetes, Obstructive Sleep Apnea and Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- TEI index
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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.
Intervention: Sham CPAP (Device)
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.
Intervention: Therapeutic CPAP (Device)
Outcomes
Primary Outcomes
TEI index
Time Frame: After 3 months of CPAP use.
Cardiac performance, evaluated through TEI index.
Strain
Time Frame: After 3 months of CPAP use.
Cardiac performance, evaluated through echocardiographic strain.
Secondary Outcomes
- Apnea hypopnea index(After 3 months CPAP use.)
- Mean oxygen saturation(After 3 months of CPAP use.)
- Highest CO2(After three months CPAP use)
- Time of saturation under 90%.(After 3 months CPAP use)
- Hemoglobin A1C(After three months of CPAP use.)
- Plasma glucose.(After 3 months of CPAP use.)
- Time of hypercapnia(After three months CPAP use.)
- Mean CO2(After three months CPAP use)
- Mean value of arterial pressure(After 3 months of CPAP use)
- Time of hypercapnia(After 3 months of CPAP use.)
Investigators
Armando Castorena-Maldonado
Head of Otolaryngology Department
Instituto Nacional de Enfermedades Respiratorias