Clinical trial NCT03221205: Effect of CPAP on Myocardial Dysfunction in Type 2 Diabetes Mellitus and Obstructive Sleep Apnea Patients
Official title: Effect of Nasal CPAP on Myocardial Dysfunction and Glycemic Control in Patients With Type 2 Diabetes, Obstructive Sleep Apnea and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Diabetes Mellitus, Type 2
Continuous Positive Airway Pressure
Myocardial Dysfunction
Echocardiography
Obesity
Keywords: sleep apnea, obstructive
obesity
DM2
TEI index
CPAP
Lead sponsor: Instituto Nacional de Enfermedades Respiratorias
Sponsor class: OTHER_GOV
Collaborators: name: Fundación Clínica Médica Sur
name: National Council of Science and Technology, Mexico
First posted: 2017-07-18
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: TEI index
timeFrame: After 3 months of CPAP use.
measure: Strain
timeFrame: After 3 months of CPAP use.
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: After three months of CPAP use.
measure: Plasma glucose.
timeFrame: After 3 months of CPAP use.
measure: Apnea hypopnea index
timeFrame: After 3 months CPAP use.
measure: Mean oxygen saturation
timeFrame: After 3 months of CPAP use.
measure: Time of hypercapnia
timeFrame: After 3 months of CPAP use.
measure: Time of hypercapnia
timeFrame: After three months CPAP use.
measure: Mean CO2
timeFrame: After three months CPAP use
measure: Highest CO2
timeFrame: After three months CPAP use
measure: Time of saturation under 90%.
timeFrame: After 3 months CPAP use
measure: Mean value of arterial pressure
timeFrame: After 3 months of CPAP use
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Insituto Nacional de Enfermedades Respiratorias
state: Delegacion Tlalpan
Study officials:
affiliation: Instituto Nacional de Enfermedades Respiratorias
name: Armando R Castorena-Maldonado, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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citation: 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
citation: Tugcu A, Yildirimturk 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. doi: 10.1253/circj.cj-09-0562. Epub 2009 Dec 15.