Evolution With CPAP Treatment of a Cohort of Type 2 Diabetic Patients With Apnea-hypopnea Syndrome (DM2-CPAP)
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ClinicalTrials.gov Identifier: NCT01307566 |
Recruitment Status
:
Completed
First Posted
: March 3, 2011
Last Update Posted
: January 6, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Apnea Type 2 Diabetes | Device: Continuous Positive Airway Pressure CPAP | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evolution With CPAP Treatment of a Cohort of Type 2 Diabetic Patients With Moderate to Severe Apnea-hypopnea Syndrome and Poor Glycemic Control |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Continuous Positive Airway Pressure
Continuous Positive Airway Pressure (CPAP)
|
Device: Continuous Positive Airway Pressure CPAP
CPAP treatment
Other Name: no other name
|
- Change in Hemoglobine A1C from baseline [ Time Frame: 14, 28, 42 and 56 weeks after initial intervention. ]
- Blood levels of fasting glucose from baseline [ Time Frame: 14 weeks after initial intervention ]
- Self measured capillary glucose profile [ Time Frame: 14 weeks after initial intervention ]
- Evening saliva collection for cortisol assay [ Time Frame: 14 weeks after initial intervention ]
- Noninvasive 24-hour ambulatory blood pressure monitoring [ Time Frame: 14 weeks after initial intervention. ]
- Analysis of urine to assess albumin to creatinine ratio [ Time Frame: 0, 14, 28, and 56 weeks after initial intervention. ]
- Blood levels of fasting insulin [ Time Frame: 14 weeks after initial intervention ]
- Blood levels of total cholesterol [ Time Frame: 14 weeks after initial intervention ]
- Blood levels of cholesterol HDL [ Time Frame: 14 weeks after initial intervention ]
- Blood levels of tryglicerids [ Time Frame: 14 weeks after initial intervention ]
- International Physical Activity Questionnaire [ Time Frame: 14 weeks after initial intervention ]
- Epworth Sleepiness Scale [ Time Frame: 14 weeks after initial intervention ]
- SF-36 v2 Health Survey [ Time Frame: 14 weeks after initial intervention ]
- subjective quantity and quality of sleep reported in a sleep log [ Time Frame: 14 weeks after initial intervention ]
- Change in ratio albumine to creatinine from baseline [ Time Frame: 14, 28, 42 and 56 weeks after initial intervention ]

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Ages Eligible for Study: | 18 Years to 69 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Type 2 diabetes on stable treatment for the last three months and HbA1C ≥ 7%
- Obstructive Sleep Apnea with and apnea-hypopnea index ≥20
- Acceptance of a therapeutic trial with CPAP
Exclusion criteria:
- Race: non caucasic
- Blood level of hemoglobin <10 in women or <11 in men or iron defitiency or hemoglobinopathy
- Glomerular filtration rate < 30
- Habitual sleeping time <6 hours per night
- Nocturnal work, shift work or unsual sleeping schedule
- Primary severe insomnia or secondary to restless legs syndrome
- Major or non stable psychiatric disorder
- Treatment with corticosteroids
- Chronic respiratory disorders that may require corticosteroids or cause respiratory insufficiency or FEV1/FVC<0.7 with FEV1<50 in spirometry
- Predominant nocturnal hypoventilation pattern
- Cardiac failure
- Alcohol abuse
- Active CPAP treatment
- Previous surgery for sleep apnea
- Severe nasal obstruction
- Illiteracy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307566
Spain | |
Granollers General Hospital | |
Granollers, Barcelnoa, Spain, 08402 |
Principal Investigator: | Marta Torrella, M.D. | Granollers General Hospital |
Responsible Party: | marta torrella, Chest Physician in Unitat de Pneumologia, Hospital de Granollers |
ClinicalTrials.gov Identifier: | NCT01307566 History of Changes |
Other Study ID Numbers: |
DM2-CPAP |
First Posted: | March 3, 2011 Key Record Dates |
Last Update Posted: | January 6, 2015 |
Last Verified: | January 2015 |
Additional relevant MeSH terms:
Apnea Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |