CPAP in Diabetes Type 2 Patients With Sleep Apnea (DM-SAHS)
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|ClinicalTrials.gov Identifier: NCT01801150|
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : March 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Sleep Apnea||Device: CPAP nasal treatment||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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)
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
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
|Hospital Universitario La Paz- IdiPaz|
|Madrid, Spain, 28046|
|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|