Skip to main content
OpenTrials
Completed

NCT Number: NCT03221205

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Apnea, Obstructive Apnea Body Weight Continuous Positive Airway Pressure Diabetes Mellitus Diabetes Mellitus, Type 2 Dyssomnias Echocardiography Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Myocardial Dysfunction Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Insituto Nacional de Enfermedades Respiratorias

Mexico City, Delegacion Tlalpan, 14080, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sham CPAP

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

Device

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

Primary outcomes

  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 outcomes

  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 a 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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Enfermedades Respiratorias

Other Gov

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2017
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.