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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)
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lifestyle and diabetes treatment | No Intervention | Counseil about lifestyle and current diabetes treatment | |
| CPAP nasal treatment | Experimental | Continuous positive airway pressure (CPAP) nasal during the night and current diabetes treatment. Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP nasal treatment | Device | Treatment with titred CPAP nasal during the nighttime |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine additional effects of CPAP on insulin resistance in patients with type 2 diabetes and SAHS. | . Determine the medium term additional effect of CPAP on insulin resistance in patients with type 2 diabetes and SAHS. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of CPAP on glycemic control | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Garcia-Rio, MD | Hospital Universitario La Paz, IdiPAZ | Study Chair |
| Elizabet MartÃnez-Cerón, MD | Hospital Universitario La Paz, IdiPAZ | Principal Investigator |
| Alberto Alonso-Fernández, MD | Hospital Son Espasses | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz- IdiPaz | Madrid | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26910598 | Derived | 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. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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 | 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 | 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 | 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 |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |