CPAP in Diabetes Type 2 Patients With Sleep Apnea
Phase 4
Completed
- Conditions
- DiabetesSleep Apnea
- Registration Number
- NCT01801150
- Lead Sponsor
- 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)
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Hospital Universitario La Paz- IdiPaz
🇪🇸Madrid, Spain
Hospital Universitario La Paz- IdiPaz🇪🇸Madrid, Spain