CPAP in Diabetes Type 2 Patients With Sleep Apnea

NCT ID: NCT01801150

Last Updated: 2015-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-01-31

Brief Summary

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Aim: To assess if six months of treatment with CPAP associated with conventional drug therapy, contribute to improved glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome SAHS)

Detailed Description

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Main objective:

To assess the effect of 6 months of CPAP treatment associated with conventional drug therapy on glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome (SAHS)

Conditions

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Diabetes Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lifestyle and diabetes treatment

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Group Type NO_INTERVENTION

No interventions assigned to this group

CPAP nasal treatment

Continuous positive airway pressure (CPAP) nasal during the night and current diabetes treatment. Device

Group Type EXPERIMENTAL

CPAP nasal treatment

Intervention Type DEVICE

Treatment with titred CPAP nasal during the nighttime

Interventions

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CPAP nasal treatment

Treatment with titred CPAP nasal during the nighttime

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* subjects 18 to 75 years old; diagnosis of type 2 diabetes mellitus; treatment with diet; oral antidiabetics or insulin stable in the last month; levels of HbA1c\> 7.5% (if not supported clinic two controls to confirm with a difference not exceeding 0.5%); overweight or obese (BMI ≥ 25 kg/m2)

Exclusion Criteria

* professional drivers, risk profession or respiratory failure; excessive daytime sleepiness is very high (Epworth scale\> 18); morbid obesity (BMI\> 40 kg/m2); CPAP treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Francisco Garcia-Rio

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco Garcia-Rio, MD

Role: STUDY_CHAIR

Hospital Universitario La Paz, IdiPAZ

Elizabet Martínez-Cerón, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz, IdiPAZ

Alberto Alonso-Fernández, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Son Espasses

Locations

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Hospital Universitario La Paz- IdiPaz

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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Martinez-Ceron E, Barquiel B, Bezos AM, Casitas R, Galera R, Garcia-Benito C, Hernanz A, Alonso-Fernandez A, Garcia-Rio F. Effect of Continuous Positive Airway Pressure on Glycemic Control in Patients with Obstructive Sleep Apnea and Type 2 Diabetes. A Randomized Clinical Trial. Am J Respir Crit Care Med. 2016 Aug 15;194(4):476-85. doi: 10.1164/rccm.201510-1942OC.

Reference Type DERIVED
PMID: 26910598 (View on PubMed)

Other Identifiers

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HULP-DM-SAHS-2012

Identifier Type: -

Identifier Source: org_study_id

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