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Sleep Apnea, ObstructiveNCT03221205

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

A study testing Therapeutic CPAP in people with Sleep Apnea, Obstructive and Diabetes Mellitus, Type 2, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Therapeutic CPAP
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
1 siteMexico
Study dates
15 Oct 2014to 24 Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Insituto Nacional de Enfermedades Respiratorias

    Mexico City, Delegacion Tlalpan, 14080

Other trials in Mexico

About this study

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

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.

Read the 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.

Being tested
Sham CPAP, Therapeutic CPAP
Keywords
sleep apnea, obstructive, obesity, DM2, TEI index, CPAP
Medical subject headings
Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sham CPAPDevice

    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 CPAPDevice

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

Study groups in NCT03221205
Study groupRoleWhat they receive
Sham CPAPSham comparatorPatients 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.
Receives: Device: Sham CPAP
Therapeutic CPAPExperimentalPatients 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.
Receives: Device: Therapeutic CPAP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TEI index

    Cardiac performance, evaluated through TEI index.

    Measured: After 3 months of CPAP use.

  2. Strain

    Cardiac performance, evaluated through echocardiographic strain.

    Measured: After 3 months of CPAP use.

Secondary outcomes (10)

  1. Hemoglobin A1C

    Glycemic control via hemoglobin A1C, percent.

    Measured: After three months of CPAP use.

  2. Plasma glucose.

    Levels of glucose in plasma, in mg/dL.

    Measured: After 3 months of CPAP use.

  3. Apnea hypopnea index

    Number of events of apnea and hypopnea per hour of sleep, evaluated through an type 3 overnight sleep study,

    Measured: After 3 months CPAP use.

  4. Mean oxygen saturation

    Mean value of the data of oxygen saturation reported in a type 3 overnight sleep study.

    Measured: After 3 months of CPAP use.

  5. 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.

    Measured: After 3 months of CPAP use.

  6. 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.

    Measured: After three months CPAP use.

  7. Mean CO2

    Mean of the values of carbon dioxide during a night of sleep, as measured via transcutaneous capnography in an overnight sleep study.

    Measured: After three months CPAP use

  8. Highest CO2

    Highest reported value of carbon dioxide during a night of sleep, as measured via transcutaneous capnography in an overnight sleep study.

    Measured: After three months CPAP use

  9. 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%.

    Measured: After 3 months CPAP use

  10. 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.

    Measured: After 3 months of CPAP use

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2017
  2. Study start15 Oct 2014
  3. Primary completion24 Oct 2017
  4. Study completion24 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03221205
Sponsor's protocol ID
C_30-13
Status last verified
Feb 2019
First submitted
14 Jul 2017
Last updated
28 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20932716

  • 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.

    PubMed 19892057

  • 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.

    PubMed 15316450

  • 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

  • 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.

    PubMed 20009388

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic CPAP in people with Sleep Apnea, Obstructive and Diabetes Mellitus, Type 2, run by Instituto Nacional de Enfermedades Respiratorias at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TEI index (time frame: After 3 months of CPAP use.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03221205, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019; AzTrials last refreshed its copy on 1 Nov 2026.

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