CPAP in Diabetes Type 2 Patients With Sleep Apnea

Diabetes Clinical Trial

— DM-SAHS  

Official title:

Effect Of Nasal CPAP On Glycemic Control In Patients With Poorly Controlled Type 2 Diabetes And Sleep Apnea-Hypopnea Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801150
• Other study ID #: HULP-DM-SAHS-2012
• Status: Completed
• Phase: Phase 4
• First received: November 16, 2012
• Last updated: March 19, 2015
• Start date: October 2011
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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)

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 information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Diabetes
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• CPAP nasal treatment
Treatment with titred CPAP nasal during the nighttime

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz- IdiPaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Impact of CPAP on glycemic control	Analyze the impact of additional treatment with CPAP on serum lipids and C-reactive protein concentration in patients with type 2 diabetes and SAHS	6 months	No
Other	Quality of life after CPAP	Establish the impact of additional treatment with CPAP on quality of life related to health of patients with type 2 diabetes and SAHS.	6 months	No
Other	Inflammatory markers after CPAP	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.	6 months	No
Other	Endocrine control with CPAP treatment	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.	6 months	No
Other	Influence of body distribution and activity on metabolic control	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.	6 months	No
Primary	Glycemic control	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)	Six months	No
Secondary	To determine additional effects of CPAP on insulin resistance in patients with type 2 diabetes and SAHS.	. Determine the medium term additional effect of CPAP on insulin resistance in patients with type 2 diabetes and SAHS.	6 months	No