Back to resultsCPAP in Diabetes Type 2 Patients With Sleep Apnea (DM-SAHS)
Primary Purpose
Diabetes, Sleep Apnea
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
CPAP nasal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes focused on measuring Diabetes, Apnea- hypopnea Syndrome, Glycemic control, Prevalence, SAHS, life quality
Eligibility Criteria
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
Sites / Locations
- Hospital Universitario La Paz- IdiPaz
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
lifestyle and diabetes treatment
CPAP nasal treatment
Arm Description
Counseil about lifestyle and current diabetes treatment
Continuous positive airway pressure (CPAP) nasal during the night and current diabetes treatment. Device
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01801150
First Posted
November 16, 2012
Last Updated
March 19, 2015
Sponsor
Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT01801150
Brief Title
CPAP in Diabetes Type 2 Patients With Sleep Apnea
Acronym
DM-SAHS
Official Title
Effect Of Nasal CPAP On Glycemic Control In Patients With Poorly Controlled Type 2 Diabetes And Sleep Apnea-Hypopnea Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Paz
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Sleep Apnea
Keywords
Diabetes, Apnea- hypopnea Syndrome, Glycemic control, Prevalence, SAHS, life quality
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lifestyle and diabetes treatment
Arm Type
No Intervention
Arm Description
Counseil about lifestyle and current diabetes treatment
Arm Title
CPAP nasal treatment
Arm Type
Experimental
Arm Description
Continuous positive airway pressure (CPAP) nasal during the night and current diabetes treatment. Device
Intervention Type
Device
Intervention Name(s)
CPAP nasal treatment
Intervention Description
Treatment with titred CPAP nasal during the nighttime
Primary Outcome Measure Information:
Title
Glycemic control
Description
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)
Time Frame
Six months
Secondary Outcome Measure Information:
Title
To determine additional effects of CPAP on insulin resistance in patients with type 2 diabetes and SAHS.
Description
. Determine the medium term additional effect of CPAP on insulin resistance in patients with type 2 diabetes and SAHS.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Impact of CPAP on glycemic control
Description
Analyze the impact of additional treatment with CPAP on serum lipids and C-reactive protein concentration in patients with type 2 diabetes and SAHS
Time Frame
6 months
Title
Quality of life after CPAP
Description
Establish the impact of additional treatment with CPAP on quality of life related to health of patients with type 2 diabetes and SAHS.
Time Frame
6 months
Title
Inflammatory markers after CPAP
Description
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.
Time Frame
6 months
Title
Endocrine control with CPAP treatment
Description
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.
Time Frame
6 months
Title
Influence of body distribution and activity on metabolic control
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Garcia-Rio, MD
Organizational Affiliation
Hospital Universitario La Paz, IdiPAZ
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Elizabet Martínez-Cerón, MD
Organizational Affiliation
Hospital Universitario La Paz, IdiPAZ
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alberto Alonso-Fernández, MD
Organizational Affiliation
Hospital Son Espasses
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Paz- IdiPaz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
26910598
Citation
Martinez-Ceron E, Barquiel B, Bezos AM, Casitas R, Galera R, Garcia-Benito C, Hernanz A, Alonso-Fernandez A, Garcia-Rio F. Effect of Continuous Positive Airway Pressure on Glycemic Control in Patients with Obstructive Sleep Apnea and Type 2 Diabetes. A Randomized Clinical Trial. Am J Respir Crit Care Med. 2016 Aug 15;194(4):476-85. doi: 10.1164/rccm.201510-1942OC.
Results Reference
derived
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CPAP in Diabetes Type 2 Patients With Sleep Apnea
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