CPAP in Diabetes Type 2 Patients With Sleep Apnea (DM-SAHS)

March 19, 2015 updated by: Francisco Garcia-Rio, Hospital Universitario La Paz

Effect Of Nasal CPAP On Glycemic Control In Patients With Poorly Controlled Type 2 Diabetes And Sleep Apnea-Hypopnea Syndrome

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz- IdiPaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: lifestyle and diabetes treatment
Counseil about lifestyle and current diabetes treatment
Experimental: CPAP nasal treatment
Continuous positive airway pressure (CPAP) nasal during the night and current diabetes treatment. Device
Device: CPAP nasal treatment
Treatment with titred CPAP nasal during the nighttime

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: Six months
To assess the effect of 6 months of CPAP therapy and conventional treatment on glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome (SAHS)
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine additional effects of CPAP on insulin resistance in patients with type 2 diabetes and SAHS.
Time Frame: 6 months
. Determine the medium term additional effect of CPAP on insulin resistance in patients with type 2 diabetes and SAHS.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of CPAP on glycemic control
Time Frame: 6 months
Analyze the impact of additional treatment with CPAP on serum lipids and C-reactive protein concentration in patients with type 2 diabetes and SAHS
6 months
Quality of life after CPAP
Time Frame: 6 months
Establish the impact of additional treatment with CPAP on quality of life related to health of patients with type 2 diabetes and SAHS.
6 months
Inflammatory markers after CPAP
Time Frame: 6 months
To evaluate the effect of CPAP on inflammatory cytokines, biomarkers of oxidative stress, sympathetic tone and intake regulating hormones in patients with type 2 diabetes and SAHS.
6 months
Endocrine control with CPAP treatment
Time Frame: 6 months

Relate the CPAP-induced changes in the concentration of HbA1c and HOMA index with changes produced in the basal inflammatory reaction, oxidative stress, sympathetic activity and intake regulatory hormones.

Identify the subset of patients with poorly controlled type 2 diabetes and SAHS in the six months of treatment with CPAP achieve a more pronounced reduction in HbA1c.
6 months
Influence of body distribution and activity on metabolic control
Time Frame: 6 months
To estimate the influence of the distribution of body mass and daily physical activity of patients with type 2 diabetes and SAHS on the metabolic response to treatment with CPAP.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Paz

Investigators

  • Study Chair: Francisco Garcia-Rio, MD, Hospital Universitario La PAZ, IdiPAZ
  • Principal Investigator: Elizabet Martínez-Cerón, MD, Hospital Universitario La PAZ, IdiPAZ
  • Principal Investigator: Alberto Alonso-Fernández, MD, Hospital Son Espasses

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULP-DM-SAHS-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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