DiabetesPhase 4DM-SAHSNCT01801150
CPAP in Diabetes Type 2 Patients With Sleep Apnea
A Phase 4 study testing CPAP nasal treatment in people with Diabetes and Sleep Apnea, run by Hospital Universitario La Paz at 1 site in Spain.
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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, Sleep Apnea
- What is being tested?
- CPAP nasal treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2011to Jan 2015
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- professional drivers, risk profession or respiratory failure; excessive daytime sleepiness is very high (Epworth scale> 18); morbid obesity (BMI> 40 kg/m2); CPAP treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Nasal CPAP On Glycemic Control In Patients With Poorly Controlled Type 2 Diabetes And Sleep Apnea-Hypopnea Syndrome
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)
Read the 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)
- Conditions
- Diabetes, Sleep Apnea
- Being tested
- CPAP nasal treatment
- Keywords
- Diabetes, Apnea- hypopnea Syndrome, Glycemic control, Prevalence, SAHS, life quality
- Medical subject headings
- Diabetes Mellitus, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP nasal treatmentDevice
Treatment with titred CPAP nasal during the nighttime
| Study group | Role | What they receive |
|---|---|---|
| lifestyle and diabetes treatment | No intervention | Counseil about lifestyle and current diabetes treatment |
| CPAP nasal treatment | Experimental | Continuous positive airway pressure (CPAP) nasal during the night and current diabetes treatment. Device Receives: Device: CPAP nasal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Six months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startOct 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Garcia-Rio, Hospital Universitario La Paz
- Investigators
- Francisco Garcia-Rio, MD, Study chair, Hospital Universitario La Paz, IdiPAZElizabet Martínez-Cerón, MD, Principal investigator, Hospital Universitario La Paz, IdiPAZAlberto Alonso-Fernández, MD, Principal investigator, Hospital Son Espasses
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801150
- Sponsor's protocol ID
- HULP-DM-SAHS-2012
- Acronym
- DM-SAHS
- Status last verified
- Mar 2015
- First submitted
- 16 Nov 2012
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26910598
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Nasal CPAP On Glycemic Control In Patients With Poorly Controlled Type 2 Diabetes And Sleep Apnea-Hypopnea Syndrome
- ClinicalTrials.gov ID
- NCT01801150
- Acronym / sponsor ID
- DM-SAHS / HULP-DM-SAHS-2012
- Conditions
- Diabetes, Sleep Apnea
- Keywords
- Diabetes, Apnea- hypopnea Syndrome, Glycemic control, Prevalence, SAHS, life quality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 28 Feb 2013 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lifestyle and diabetes treatment | No intervention | –Counseil about lifestyle and current diabetes treatment |
| CPAP nasal treatment | Experimental | Device: CPAP nasal treatmentContinuous positive airway pressure (CPAP) nasal during the night and current diabetes treatment. Device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- professional drivers, risk profession or respiratory failure; excessive daytime sleepiness is very high (Epworth scale> 18); morbid obesity (BMI> 40 kg/m2); CPAP treatment
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 |
|---|---|---|
| CPAP nasal treatmentTreatment with titred CPAP nasal during the nighttime | Device | CPAP nasal treatment |
Primary outcome
Glycemic control
Time frame: 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)
1 secondary outcome
To determine additional effects of CPAP on insulin resistance in patients with type 2 diabetes and SAHS.
Time frame: 6 months
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 24 Mar 2015.
- Derived from this study: PubMed 26910598Martinez-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.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Francisco Garcia-Rio, MD study chair
Hospital Universitario La Paz, IdiPAZ
Elizabet Martínez-Cerón, MD principal investigator
Hospital Universitario La Paz, IdiPAZ
Alberto Alonso-Fernández, MD principal investigator
Hospital Son Espasses
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CPAP nasal treatment in people with Diabetes and Sleep Apnea, run by Hospital Universitario La Paz 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 1 inclusion and 1 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 24 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Glycemic control (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01801150, which also lists 1 linked publication.
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 24 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.