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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01801150
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):
Francisco Garcia-Rio, Hospital Universitario La Paz

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Diabetes Sleep Apnea Device: CPAP nasal treatment Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect Of Nasal CPAP On Glycemic Control In Patients With Poorly Controlled Type 2 Diabetes And Sleep Apnea-Hypopnea Syndrome
Study Start Date : October 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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

  2. 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.

  3. 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.

  4. 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.


  5. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801150


Locations
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Spain
Hospital Universitario La Paz- IdiPaz
Madrid, Spain, 28046
Sponsors and Collaborators
Hospital Universitario La Paz
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francisco Garcia-Rio, PhD, Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01801150    
Other Study ID Numbers: HULP-DM-SAHS-2012
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015
Keywords provided by Francisco Garcia-Rio, Hospital Universitario La Paz:
Diabetes
Apnea- hypopnea Syndrome
Glycemic control
Prevalence
SAHS
life quality
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases