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

NCT ID: NCT03221205

Last Updated: 2019-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-15
• Study Completion Date: 2017-11-24

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Sham CPAP

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Therapeutic CPAP

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Therapeutic CPAP

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

Intervention Type: DEVICE

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).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Clínica Médica Sur

OTHER

Sponsor Role: collaborator

National Council of Science and Technology, Mexico

OTHER

Sponsor Role: collaborator

Instituto Nacional de Enfermedades Respiratorias

OTHER_GOV

Sponsor Role: lead

Responsible Party

Armando Castorena-Maldonado

Head of Otolaryngology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Armando R Castorena-Maldonado, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Enfermedades Respiratorias

Locations

Insituto Nacional de Enfermedades Respiratorias

Mexico City, Delegacion Tlalpan, Mexico

Countries

Mexico

References

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.

Reference Type: BACKGROUND

PMID: 20932716 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19892057 (View on PubMed)

Marwick TH. Tissue Doppler imaging for evaluation of myocardial function in patients with diabetes mellitus. Curr Opin Cardiol. 2004 Sep;19(5):442-6. doi: 10.1097/01.hco.0000131535.32657.87.

Reference Type: BACKGROUND

PMID: 15316450 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 20009388 (View on PubMed)

Other Identifiers

C_30-13

Identifier Type: -

Identifier Source: org_study_id