CPAP in Diabetes Type 2 Patients With Sleep Apnea

Phase 4

Completed

• Conditions: Diabetes; Sleep Apnea
• Interventions: Device: CPAP nasal treatment

• 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)

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-24

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

Arm && Interventions

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

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