DiabetesNCT02482584
Impact of CPAP Treatment on Arterial Stiffness in Patients With T2DM and Newly Diagnosed Obstructive Sleep Apnoea
A study testing CPAP in people with Diabetes and Obstructive Sleep Apnea, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The purpose of the trial is to investigate the effects of three months' treatment with a CPAP-device versus control group on change in arterial stiffness in type 2 diabetes (T2D) patients with newly detected Obstructive Sleep Apnoea (OSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Obstructive Sleep Apnea
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2015to Aug 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus (WHO criteria)
- Obstructive sleep apnea defined as apnoea-hypopnoea index (AHI) > 15 diagnosed with ApneaLink+® measured within three months or less prior to visit 0.
- Signed informed content.
Who cannot join
- Contraindications to CPAP treatment.
- Treatment with CPAP within the last 6 months prior to visit 1.
- Works in a transportation-related industry
- C-peptide < 300 pmol/l - measured less than 6 months prior to visit 0
- HbA1c:< 7% or >10% - both exclusive - at visit 0
- Changes in antidiabetic treatment during the last four weeks prior to visit 0.
- Unstable bodyweight, i.e. >5% change during the last three months prior to visit 0.
- Other sleep breathing disorder
Trial locations and contacts
1 site in 1 country.
Anne Banghøj, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Nordsjællands hospital
Hillerød, 3400
Anne Banghøj, MD, anne.margareta.banghoej@regionh.dk
About this study
Official title: DiaBOSA: Impact of CPAP Treatment on Arterial Stiffness in Patients With Type 2 Diabetes and Newly Diagnosed Obstructive Sleep Apnoea
The purpose of the trial is to investigate the effects of three months' treatment with a CPAP-device versus control group on change in arterial stiffness in type 2 diabetes (T2D) patients with newly detected Obstructive Sleep Apnoea (OSA).
Read the detailed description
Background: Obstructive sleep apnoea (OSA) is a common disorder characterised by recurrent episodes of apnoea or hypopnoea during sleep. OSA is associated with excessive daytime sleepiness and linked to increased cardiovascular morbidity and mortality. OSA can be alleviated with Continuous Positive Airway Pressure (CPAP) treatment.
Cardiovascular disease is the major cause of decreased life expectancy, morbidity and reduced quality of life in patients with type 2 diabetes (T2D). Increased stiffness of the aorta has been associated with increased cardiovascular morbidity and mortality in diabetic patients.
Previous studies have reported a much higher frequency of OSA in patients with obesity and T2D compared with non-diabetic subjects, and found that OSA was associated with arterial stiffness. However, whether CPAP treatment improves arterial stiffness and insulin sensitivity in T2D patients remain to be elucidated.
Objective: To investigate the effects of three months' treatment with a CPAP-device versus sham CPAP on change in arterial stiffness in T2D patients with newly detected OSA.
Design: Randomised, controlled, multicentre study of intervention with CPAP treatment versus control group. The treatment period is three months with a subsequent 9 months open extension.
Patient population: 70 patients with T2D and newly diagnosed OSA recruited from Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Department of Endocrinology, Gentofte University Hospital, Department of Endocrinology and Internal Medicine, Aarhus University Hospital Nørrebrogade and Department of Internal Medicine, Silkeborg Sygehus.
Intervention: CPAP treatment versus control group.
Endpoints:
Primary endpoint: Change in arterial stiffness measured by office carotid-femoral pulse wave velocity (cf-PWV) from start to end of 12 weeks intervention.
- Conditions
- Diabetes, Obstructive Sleep Apnea
- Being tested
- CPAP, Control
- Medical subject headings
- Diabetes Mellitus, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
CPAP intervention
ControlOther
Control
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Active comparator | Continuous Positive Airway Pressure (CPAP) treatment during three month. Receives: Device: CPAP |
| Control group | Other | Control group Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in arterial stiffness measured by office carotid-femoral pulse wave velocity (cf-PWV) from start to end of 12 weeks intervention
Measured: three month
Secondary outcomes (1)
Change from start to end of 13 weeks intervention in insulin sensitivity measured by hyperinsulinemic euglycemic clamp
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2018 (estimated)
- Study completionAug 2018 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Esben Laugesen, MD, Principal investigator, Aarhus Universitets Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482584
- Sponsor's protocol ID
- DiaBOSA
- Status last verified
- Nov 2016
- First submitted
- 31 Mar 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hvelplund Kristiansen M, Banghoj AM, Laugesen E, Tarnow L. Arterial stiffness in people with Type 2 diabetes and obstructive sleep apnoea. Diabet Med. 2018 Oct;35(10):1391-1398. doi: 10.1111/dme.13666. Epub 2018 May 24.
PubMed 29763980
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiaBOSA: Impact of CPAP Treatment on Arterial Stiffness in Patients With Type 2 Diabetes and Newly Diagnosed Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT02482584
- Acronym / sponsor ID
- DiaBOSA
- Conditions
- Diabetes, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Apr 2015
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 26 Jun 2015 (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 purpose of the trial is to investigate the effects of three months' treatment with a CPAP-device versus control group on change in arterial stiffness in type 2 diabetes (T2D) patients with newly detected Obstructive Sleep Apnoea (OSA).
Detailed description
Background: Obstructive sleep apnoea (OSA) is a common disorder characterised by recurrent episodes of apnoea or hypopnoea during sleep. OSA is associated with excessive daytime sleepiness and linked to increased cardiovascular morbidity and mortality. OSA can be alleviated with Continuous Positive Airway Pressure (CPAP) treatment.
Cardiovascular disease is the major cause of decreased life expectancy, morbidity and reduced quality of life in patients with type 2 diabetes (T2D). Increased stiffness of the aorta has been associated with increased cardiovascular morbidity and mortality in diabetic patients.
Previous studies have reported a much higher frequency of OSA in patients with obesity and T2D compared with non-diabetic subjects, and found that OSA was associated with arterial stiffness. However, whether CPAP treatment improves arterial stiffness and insulin sensitivity in T2D patients remain to be elucidated.
Objective: To investigate the effects of three months' treatment with a CPAP-device versus sham CPAP on change in arterial stiffness in T2D patients with newly detected OSA.
Design: Randomised, controlled, multicentre study of intervention with CPAP treatment versus control group. The treatment period is three months with a subsequent 9 months open extension.
Patient population: 70 patients with T2D and newly diagnosed OSA recruited from Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Department of Endocrinology, Gentofte University Hospital, Department of Endocrinology and Internal Medicine, Aarhus University Hospital Nørrebrogade and Department of Internal Medicine, Silkeborg Sygehus.
Intervention: CPAP treatment versus control group.
Endpoints:
Primary endpoint: Change in arterial stiffness measured by office carotid-femoral pulse wave velocity (cf-PWV) from start to end of 12 weeks intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Active comparator | Device: CPAPContinuous Positive Airway Pressure (CPAP) treatment during three month. |
| Control group | Other | Other: ControlControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus (WHO criteria)
- Obstructive sleep apnea defined as apnoea-hypopnoea index (AHI) > 15 diagnosed with ApneaLink+® measured within three months or less prior to visit 0.
- Signed informed content.
Key exclusion criteria (8 listed)
- Contraindications to CPAP treatment.
- Treatment with CPAP within the last 6 months prior to visit 1.
- Works in a transportation-related industry
- C-peptide < 300 pmol/l - measured less than 6 months prior to visit 0
- HbA1c:< 7% or >10% - both exclusive - at visit 0
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 |
|---|---|---|
| CPAPCPAP intervention | Device | CPAP treatment |
| ControlControl | Other | Control group |
Primary outcome
Change in arterial stiffness measured by office carotid-femoral pulse wave velocity (cf-PWV) from start to end of 12 weeks intervention
Time frame: three month
1 secondary outcome
Change from start to end of 13 weeks intervention in insulin sensitivity measured by hyperinsulinemic euglycemic clamp
Time frame: three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Derived from this study: PubMed 29763980Hvelplund Kristiansen M, Banghoj AM, Laugesen E, Tarnow L. Arterial stiffness in people with Type 2 diabetes and obstructive sleep apnoea. Diabet Med. 2018 Oct;35(10):1391-1398. doi: 10.1111/dme.13666. Epub 2018 May 24.
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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.
Anne Banghøj, MD contact
Esben Laugesen, MD principal investigator
Aarhus Universitets 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 CPAP in people with Diabetes and Obstructive Sleep Apnea, run by Nordsjaellands Hospital at 1 site in Denmark.
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 8 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: status not confirmed, as of the sponsor's last update on 28 Mar 2017. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Banghøj, MD (anne.margareta.banghoej@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in arterial stiffness measured by office carotid-femoral pulse wave velocity (cf-PWV) from start to end of 12 weeks intervention (time frame: three month). 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 NCT02482584, 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 28 Mar 2017.