Sleep ApneaDM2-CPAPNCT01307566
Evolution With CPAP Treatment of a Cohort of Type 2 Diabetic Patients With Apnea-hypopnea Syndrome
A study testing Continuous Positive Airway Pressure CPAP in people with Sleep Apnea and Type 2 Diabetes, run by Hospital de Granollers at 1 site in Spain.
Trial summary
The main purpose of this study is to measure the evolution of hemoglobin A1c level after treatment with CPAP in a cohort of type 2 diabetes mellitus patients with poor glycemic control and associated moderate or severe obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Sleep Apnea, Type 2 Diabetes
- What is being tested?
- Continuous Positive Airway Pressure CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2011to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The main purpose of this study is to measure the evolution of hemoglobin A1c level after treatment with CPAP in a cohort of type 2 diabetes mellitus patients with poor glycemic control and associated moderate or severe obstructive sleep apnea.
Read the detailed description
Subjects with poorly controlled type 2 diabetes are a high cardiovascular risk group in which a high prevalence of moderate to severe sleep apnea is expected. Studies based on interstitial glycemic measurement demonstrate a reduction in glucose levels when treating sleep apnea with CPAP. Nevertheless, the effectiveness of CPAP in improving glycemic control has been questioned as most studies have failed to demonstrate a reduction in hemoglobin A1c (HbA1C) level over time. Most of these studies have limitations such as a short follow-up or a suboptimal fulfillment of CPAP treatment. We hypothesize that treating moderate to severe sleep apnea with CPAP will improve glycemic control (measured by HbA1C) at 14 weeks in good compliers and that this improvement will be sustained at one year. We aim to test this hypothesis in consecutive type 2 diabetes patients on stable treatment with HbA1c ≥7% in routine outpatient visits in our Diabetes, Nutrition and Endocrinology Unit. After providing informed consent, patients will be screened for sleep apnea by nocturnal oximetry followed by a diagnostic respiratory polygraphy. Those patients with obstructive sleep apnea with an apnea-hypopnea index ≥20 will be invited to enter the study. After a 3-month observation period without any intervention to rule out a potential influence of entering the study on HbA1C levels, patients will be treated with CPAP. HbA1C levels will be measured at baseline, after 14 weeks, and thereafter every 14 weeks until completing one year of treatment. Other endocrine, metabolic and cardiovascular risk variables will be determined at baseline and at 14 weeks of the intervention.
- Conditions
- Sleep Apnea, Type 2 Diabetes
- Being tested
- Continuous Positive Airway Pressure CPAP
- Medical subject headings
- Sleep Apnea Syndromes, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure CPAPDevice
Also called no other name
CPAP treatment
| Study group | Role | What they receive |
|---|---|---|
| Continuous Positive Airway Pressure | Experimental | Continuous Positive Airway Pressure (CPAP) Receives: Device: Continuous Positive Airway Pressure CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobine A1C from baseline
Measured: 14, 28, 42 and 56 weeks after initial intervention.
Secondary outcomes (14)
Blood levels of fasting glucose from baseline
Measured: 14 weeks after initial intervention
Self measured capillary glucose profile
Measured: 14 weeks after initial intervention
Evening saliva collection for cortisol assay
Measured: 14 weeks after initial intervention
Noninvasive 24-hour ambulatory blood pressure monitoring
Measured: 14 weeks after initial intervention.
Analysis of urine to assess albumin to creatinine ratio
Measured: 0, 14, 28, and 56 weeks after initial intervention.
Blood levels of fasting insulin
Measured: 14 weeks after initial intervention
Blood levels of total cholesterol
Measured: 14 weeks after initial intervention
Blood levels of cholesterol HDL
Measured: 14 weeks after initial intervention
Blood levels of tryglicerids
Measured: 14 weeks after initial intervention
International Physical Activity Questionnaire
Measured: 14 weeks after initial intervention
Epworth Sleepiness Scale
Measured: 14 weeks after initial intervention
SF-36 v2 Health Survey
Measured: 14 weeks after initial intervention
subjective quantity and quality of sleep reported in a sleep log
Measured: 14 weeks after initial intervention
Change in ratio albumine to creatinine from baseline
Measured: 14, 28, 42 and 56 weeks after initial intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Collaborators
- EsteveTeijin Healthcare
- Responsible party
- Principal investigator, marta torrella, Hospital de Granollers
- Investigators
- Marta Torrella, M.D., Principal investigator, Granollers General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01307566
- Sponsor's protocol ID
- DM2-CPAP
- Acronym
- DM2-CPAP
- Status last verified
- Jan 2015
- First submitted
- 11 Feb 2011
- Last updated
- 6 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01307566
- Acronym / sponsor ID
- DM2-CPAP / DM2-CPAP
- Conditions
- Sleep Apnea, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Collaborators
- EsteveTeijin Healthcare
- Study start
- Mar 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to measure the evolution of hemoglobin A1c level after treatment with CPAP in a cohort of type 2 diabetes mellitus patients with poor glycemic control and associated moderate or severe obstructive sleep apnea.
Detailed description
Subjects with poorly controlled type 2 diabetes are a high cardiovascular risk group in which a high prevalence of moderate to severe sleep apnea is expected. Studies based on interstitial glycemic measurement demonstrate a reduction in glucose levels when treating sleep apnea with CPAP. Nevertheless, the effectiveness of CPAP in improving glycemic control has been questioned as most studies have failed to demonstrate a reduction in hemoglobin A1c (HbA1C) level over time. Most of these studies have limitations such as a short follow-up or a suboptimal fulfillment of CPAP treatment. We hypothesize that treating moderate to severe sleep apnea with CPAP will improve glycemic control (measured by HbA1C) at 14 weeks in good compliers and that this improvement will be sustained at one year. We aim to test this hypothesis in consecutive type 2 diabetes patients on stable treatment with HbA1c ≥7% in routine outpatient visits in our Diabetes, Nutrition and Endocrinology Unit. After providing informed consent, patients will be screened for sleep apnea by nocturnal oximetry followed by a diagnostic respiratory polygraphy. Those patients with obstructive sleep apnea with an apnea-hypopnea index ≥20 will be invited to enter the study. After a 3-month observation period without any intervention to rule out a potential influence of entering the study on HbA1C levels, patients will be treated with CPAP. HbA1C levels will be measured at baseline, after 14 weeks, and thereafter every 14 weeks until completing one year of treatment. Other endocrine, metabolic and cardiovascular risk variables will be determined at baseline and at 14 weeks of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Positive Airway Pressure | Experimental | Device: Continuous Positive Airway Pressure CPAPContinuous Positive Airway Pressure (CPAP) |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway Pressure CPAPAlso: no other nameCPAP treatment | Device | Continuous Positive Airway Pressure |
Primary outcome
Change in Hemoglobine A1C from baseline
Time frame: 14, 28, 42 and 56 weeks after initial intervention.
14 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Torrella, M.D. principal investigator
Granollers General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure CPAP in people with Sleep Apnea and Type 2 Diabetes, run by Hospital de Granollers at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobine A1C from baseline (time frame: 14, 28, 42 and 56 weeks after initial intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.