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
Verified date | February 2019 |
Source | Instituto Nacional de Enfermedades Respiratorias |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Mexico | Insituto Nacional de Enfermedades Respiratorias | Mexico City | Delegacion Tlalpan |
Lead Sponsor | Collaborator |
---|---|
Instituto Nacional de Enfermedades Respiratorias | Fundación Clínica Médica Sur, National Council of Science and Technology, Mexico |
Mexico,
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
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 |
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