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

February 26, 2019 updated by: Armando Castorena-Maldonado, Instituto Nacional de Enfermedades Respiratorias

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Delegacion Tlalpan
      • Mexico City, Delegacion Tlalpan, Mexico, 14080
        • Insituto Nacional de Enfermedades Respiratorias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 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.
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.
Experimental: 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.
Device: Therapeutic CPAP
Use of CPAP (ResMed AutoSet S9 with humidifier) through nasal mask and tube with automatized pressure from 4 to 20 cmH2O.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TEI index
Time Frame: After 3 months of CPAP use.
Cardiac performance, evaluated through TEI index.
After 3 months of CPAP use.
Strain
Time Frame: After 3 months of CPAP use.
Cardiac performance, evaluated through echocardiographic strain.
After 3 months of CPAP use.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1C
Time Frame: After three months of CPAP use.
Glycemic control via hemoglobin A1C, percent.
After three months of CPAP use.
Plasma glucose.
Time Frame: After 3 months of CPAP use.
Levels of glucose in plasma, in mg/dL.
After 3 months of CPAP use.
Apnea hypopnea index
Time Frame: After 3 months CPAP use.
Number of events of apnea and hypopnea per hour of sleep, evaluated through an type 3 overnight sleep study,
After 3 months CPAP use.
Mean oxygen saturation
Time Frame: After 3 months of CPAP use.
Mean value of the data of oxygen saturation reported in a type 3 overnight sleep study.
After 3 months of CPAP use.
Time of hypercapnia
Time Frame: After 3 months of CPAP use.
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.
Time of hypercapnia
Time Frame: After three months CPAP use.
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.
Mean CO2
Time Frame: After three months CPAP use
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
Highest CO2
Time Frame: After three months CPAP use
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
Time of saturation under 90%.
Time Frame: After 3 months CPAP use
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
Mean value of arterial pressure
Time Frame: After 3 months of CPAP use
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Enfermedades Respiratorias

Collaborators

National Council of Science and Technology, Mexico
Fundación Clínica Médica Sur

Investigators

  • Principal Investigator: Armando R Castorena-Maldonado, MD, Instituto Nacional de Enfermedades Respiratorias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2014

Primary Completion (Actual)

October 24, 2017

Study Completion (Actual)

November 24, 2017

Study Registration Dates

First Submitted

July 14, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C_30-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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