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

NCT03221205 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2019-02-28

No results posted yet for this study

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

Conditions

  • Sleep Apnea, Obstructive
  • Diabetes Mellitus, Type 2
  • Continuous Positive Airway Pressure
  • Myocardial Dysfunction
  • Echocardiography
  • Obesity

Interventions

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.

DEVICE

Therapeutic CPAP

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

Sponsors & Collaborators

  • Fundación Clínica Médica Sur

    collaborator OTHER

  • National Council of Science and Technology, Mexico

    collaborator OTHER

  • Instituto Nacional de Enfermedades Respiratorias

    lead OTHER_GOV

Principal Investigators

  • Armando R Castorena-Maldonado, MD · Instituto Nacional de Enfermedades Respiratorias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-15
Primary Completion
2017-10-24
Completion
2017-11-24

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03221205 on ClinicalTrials.gov