Diabetes, Sleep Apnea
Conditions
Keywords
Diabetes, Apnea- hypopnea Syndrome, Glycemic control, Prevalence, SAHS, life quality
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)
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)
Interventions
DEVICECPAP nasal treatment
Treatment with titred CPAP nasal during the nighttime
Sponsors
Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | 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
| Measure | Time frame | Description |
|---|---|---|
| To determine additional effects of CPAP on insulin resistance in patients with type 2 diabetes and SAHS. | 6 months | . Determine the medium term additional effect of CPAP on insulin resistance in patients with type 2 diabetes and SAHS. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory markers after CPAP | 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. |
| Impact of CPAP on glycemic control | 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 |
| Influence of body distribution and activity on metabolic control | 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. |
| Endocrine control with CPAP treatment | 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. |
| Quality of life after CPAP | 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. |
Countries
Spain
Outcome results
None listed