NCT03221205

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2017

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

3 years

First QC Date

July 14, 2017

Last Update Submit

February 26, 2019

Conditions

Sleep Apnea, ObstructiveDiabetes Mellitus, Type 2Continuous Positive Airway PressureMyocardial DysfunctionEchocardiographyObesity

Keywords

sleep apnea, obstructiveobesityDM2TEI indexCPAP

Outcome Measures

Primary Outcomes (2)

  • TEI index

    Cardiac performance, evaluated through TEI index.

    After 3 months of CPAP use.

  • Strain

    Cardiac performance, evaluated through echocardiographic strain.

    After 3 months of CPAP use.

Secondary Outcomes (10)

  • Hemoglobin A1C

    After three months of CPAP use.

  • Plasma glucose.

    After 3 months of CPAP use.

  • Apnea hypopnea index

    After 3 months CPAP use.

  • Mean oxygen saturation

    After 3 months of CPAP use.

  • Time of hypercapnia

    After 3 months of CPAP use.

  • +5 more secondary outcomes

Study Arms (2)

Sham CPAP

SHAM COMPARATOR

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

Therapeutic CPAP

EXPERIMENTAL

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

Interventions

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.

Sham CPAP
Therapeutic CPAPDEVICE

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

Therapeutic CPAP

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Insituto Nacional de Enfermedades Respiratorias

Mexico City, Delegacion Tlalpan, 14080, Mexico

Location

Related Publications (5)

  • 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.

    PMID: 20932716BACKGROUND

  • 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.

    PMID: 19892057BACKGROUND

  • 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.

    PMID: 15316450BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 20009388BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDiabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Armando R Castorena-Maldonado, MD

    Instituto Nacional de Enfermedades Respiratorias

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Otolaryngology Department

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 18, 2017

Study Start

October 15, 2014

Primary Completion

October 24, 2017

Study Completion

November 24, 2017

Last Updated

February 28, 2019

Record last verified: 2019-02

Locations

ME(1)