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

Madrid Health Service

Status and phase: Completed; Phase 4

Conditions: Diabetes; Sleep Apnea

Treatments: Device: CPAP nasal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01801150

HULP-DM-SAHS-2012

Details and patient eligibility

About

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)

Full 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)

Enrollment: 61 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

lifestyle and diabetes treatment

No Intervention group

Description:

Counseil about lifestyle and current diabetes treatment

CPAP nasal treatment

Experimental group

Description:

Continuous positive airway pressure (CPAP) nasal during the night and current diabetes treatment. Device

Treatment:

Device: CPAP nasal treatment