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

M

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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