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

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ClinicalTrials.gov Identifier: NCT03221205
Recruitment Status : Active, not recruiting
First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Collaborators:
Fundación Clínica Médica Sur
National Council of Science and Technology, Mexico
Information provided by (Responsible Party):
Armando Castorena-Maldonado, Instituto Nacional de Enfermedades Respiratorias

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 ecocardiogram, laboratory studies, ambulatory monitoring of arterial tension and sleep study before and after CPAP use.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Diabetes Mellitus, Type 2 Continuous Positive Airway Pressure Myocardial Dysfunction Echocardiography Obesity Device: Sham CPAP Device: Therapeutic CPAP Not Applicable

Detailed Description:
The obstructive sleep apnea syndrome (OSAS) is a disease characterized by repeated episodes of partial o 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, and 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 comparation 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  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Nasal CPAP on Myocardial Dysfunction and Glycemic Control in Patients With Type 2 Diabetes, Obstructive Sleep Apnea and Obesity
Actual Study Start Date : October 15, 2014
Estimated Primary Completion Date : October 15, 2017
Estimated Study Completion Date : November 1, 2017


Arm Intervention/treatment
Sham Comparator: Sham CPAP
Patientes 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 (messured 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.




Primary Outcome Measures :
  1. TEI index [ Time Frame: After 3 months of CPAP use. ]
    Cardiac performance, evaluated through TEI index.

  2. Strain [ Time Frame: After 3 months of CPAP use. ]
    Cardiac performance, evaluated through echocardiographic strain.


Secondary Outcome Measures :
  1. Hemoglobin A1C [ Time Frame: After three months of CPAP use. ]
    Glycemic control via hemoglobin A1C, percent.

  2. Plasma glucose. [ Time Frame: After 3 months of CPAP use. ]
    Levels of glucose in plasma, in mg/dL.

  3. 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,

  4. Mean oxygen saturation [ Time Frame: After 3 months of CPAP use. ]
    Mean value of the data of oxygen saturation reported in an type 3 overnight sleep study.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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%.

  10. 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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, sulphonilurea, meglitinide, tiazolinedione, alpha-glucosidasa 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221205


Locations
Mexico
Insituto Nacional de Enfermedades Respiratorias
Mexico City, Delegacion Tlalpan, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Enfermedades Respiratorias
Fundación Clínica Médica Sur
National Council of Science and Technology, Mexico
Investigators
Principal Investigator: Armando R Castorena-Maldonado, MD Instituto Nacional de Enfermedades Respiratorias

Publications:
Responsible Party: Armando Castorena-Maldonado, Head of Otolaryngology Department, Instituto Nacional de Enfermedades Respiratorias
ClinicalTrials.gov Identifier: NCT03221205     History of Changes
Other Study ID Numbers: C_30-13
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Armando Castorena-Maldonado, Instituto Nacional de Enfermedades Respiratorias:
sleep apnea, obstructive
obesity
DM2
TEI index
CPAP

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases