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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221205
• Other study ID #: C_30-13
• Status: Completed
• Phase: N/A
• Start date: October 15, 2014
• Est. completion date: November 24, 2017

Study information

• Verified date: February 2019
• Source: Instituto Nacional de Enfermedades Respiratorias
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 24, 2017
• Est. primary completion date: October 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Device:
• Sham CPAP
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.
• Therapeutic CPAP
Use of CPAP (ResMed AutoSet S9 with humidifier) through nasal mask and tube with automatized pressure from 4 to 20 cmH2O.

Locations

Country	Name	City	State
Mexico	Insituto Nacional de Enfermedades Respiratorias	Mexico City	Delegacion Tlalpan

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Nacional de Enfermedades Respiratorias	Fundación Clínica Médica Sur, National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (5)

Carrillo-Alduenda JL, Arredondo del Bosque F, Reyes-Zúñiga M, Barabia Ortega B, Yáñez-Gutiérrez L, Torre-Bouscoulet L, Castorena-Maldonado A. Índice de funcionamiento miocárdico en pacientes con síndrome de apnea obstructiva del sueño. Neumología y cirugía de tórax. 2009;68(3):100-105

Ernande L, Rietzschel ER, Bergerot C, De Buyzere ML, Schnell F, Groisne L, Ovize M, Croisille P, Moulin P, Gillebert TC, Derumeaux G. Impaired myocardial radial function in asymptomatic patients with type 2 diabetes mellitus: a speckle-tracking imaging study. J Am Soc Echocardiogr. 2010 Dec;23(12):1266-72. doi: 10.1016/j.echo.2010.09.007. Epub 2010 Oct 8. — View Citation

Marwick TH. Tissue Doppler imaging for evaluation of myocardial function in patients with diabetes mellitus. Curr Opin Cardiol. 2004 Sep;19(5):442-6. Review. — View Citation

Ng AC, Delgado V, Bertini M, van der Meer RW, Rijzewijk LJ, Shanks M, Nucifora G, Smit JW, Diamant M, Romijn JA, de Roos A, Leung DY, Lamb HJ, Bax JJ. Findings from left ventricular strain and strain rate imaging in asymptomatic patients with type 2 diabetes mellitus. Am J Cardiol. 2009 Nov 15;104(10):1398-401. doi: 10.1016/j.amjcard.2009.06.063. Epub 2009 Sep 26. — View Citation

Tugcu A, Yildirimtürk O, Tayyareci Y, Demiroglu C, Aytekin S. Evaluation of subclinical right ventricular dysfunction in obstructive sleep apnea patients using velocity vector imaging. Circ J. 2010 Feb;74(2):312-9. Epub 2009 Dec 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEI index	Cardiac performance, evaluated through TEI index.	After 3 months of CPAP use.
Primary	Strain	Cardiac performance, evaluated through echocardiographic strain.	After 3 months of CPAP use.
Secondary	Hemoglobin A1C	Glycemic control via hemoglobin A1C, percent.	After three months of CPAP use.
Secondary	Plasma glucose.	Levels of glucose in plasma, in mg/dL.	After 3 months of CPAP use.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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