Diabetes Mellitus Type 2NCT00509223
GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes
A study testing Positive Airway Pressure therapy and Lifestyle counseling in people with Diabetes Mellitus Type 2, run by ResMed at 15 sites in 3 countries.
Trial summary
Obstructive Sleep Apnea (OSA) and type 2 diabetes mellitus are two prevalent medical conditions with significant associated cardiovascular and cerebrovascular morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Positive Airway Pressure therapy and Lifestyle counseling
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 15 sitesin 3 countries
- Study dates
- Jul 2007to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 18 years of age or older,
- Known diagnosis of type 2 diabetes for at least 3 months
- HbA1c >6.5% and </= 8.5%
- BMI </= 40 kg/m2
Who cannot join
- Requires oxygen therapy
- OSA is severe (AHI>70 or SaO2<70%)
- Work in transport related industries
- Previous diagnosis of OSA
- Known MVA due to sleepiness in the previous 5 years
- Insulin-requiring
- Use of GLP-1 mimetic (e.g. Byetta) for < 6 months or > 6 months but weight not stable
- Unstable angina
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States11 sites
Johns Hopkins University
Baltimore, Maryland, 21224
SleepMed of West Ashley
Charleston, South Carolina, 29407
SleepMed of South Carolina
Columbia, South Carolina, 29201
OSU Sleep Medicine Program
Columbus, Ohio, 43210
Clinical Research of South Florida
Coral Gables, Florida, 33134
SleepMed of Central Georgia
Macon, Georgia, 31201
Mission Internal Medical Group
Mission Viejo, California, 92691
Rochester Clinical Research
Rochester, New York, 14609
International Diabetes Center
Saint Louis Park, Minnesota, 55416
Cetero Research
San Antonio, Texas, 78229
Advanced Metabolic Care and Research Institute
Temecula, California, 92951
Australia3 sites
Eastern Clinical Research Unit
Box Hill, Victoria, 3128
Baker IDI Heart and Diabetes Institute
Melbourne, Victoria, 3004
Royal North Shore Hospital
Sydney, New South Wales, 2065
About this study
Official title: Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes and Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA) and type 2 diabetes mellitus are two prevalent medical conditions with significant associated cardiovascular and cerebrovascular morbidity and mortality. Research indicates that the prevalence of OSA is increased in diabetic patients when compared with normoglycemic patients and that OSA is independently associated with type 2 diabetes. Further research suggests that effective treatment of the OSA with continuous positive airway pressure (CPAP) improves insulin responsiveness in both non-diabetic OSA patients and diabetic-OSA patients. We are proposing a clinical trial to evaluate the impact of 6 months of CPAP therapy on glycemic control in type 2 diabetic patients with OSA.
The primary objective of this study is to assess the effectiveness of CPAP in improving glycemic control (HbA1c) in type 2 diabetic patients with newly diagnosed OSA. Secondary objectives of this study include: assessment of fasting and post prandial glucose, determination as to whether there are any biochemical markers for OSA in the type 2 diabetic population; assessment of any improvements in cardiovascular outcomes; evaluation of any improvement in quality of life. Patients with OSA will be randomized into one of two groups: either a CPAP treatment group or a non-treatment group. Patients will be followed at 3 months and 6 months with collection of various lab tests to assess glycemic control.
Read the detailed description
Patients attending clinical sites involved with the trial will be asked to participate in the study. Patients will undergo a sleep test and if positive for Obstructive Sleep Apnea (OSA) will continue in the study.
At the time of enrolment baseline history and physical examination will be assessed. Baseline lab samples will also be obtained to measure levels of fasting blood glucose, insulin, HbA1c, lipids, biochemical markers and creatinine/albumin ratio. Post-prandial glucose levels and 24-hour ambulatory blood pressure will be evaluated. Participants will also be asked to complete Quality of Life (QoL) questionnaires.
Participants will be randomised into either continuous positive airway pressure CPAP treatment or no treatment. All subjects will be counselled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations. Follow-up on adoption of the healthy lifestyle approach will be done for all study participants for the duration of the trial period. Total duration of a patient's participation is 6 months.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Positive Airway Pressure therapy, Lifestyle counseling
- Keywords
- Type 2 diabetes, Obstructive sleep apnea, Glycemic control, Insulin resistance, Sleep disordered breathing
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Apnea, Obstructive, Insulin Resistance, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway Pressure therapyDevice
Also called ResMed AutoSet S8
Positive Airway Pressure (PAP) therapy initiated at Randomization and continued through the entire study duration (6 months), with instructions for use on a daily basis, during periods of sleep.
Lifestyle counselingBehavioural
Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Lifestyle counseling with Positive Airway Pressure (PAP) therapy Receives: Device: Positive Airway Pressure therapy; Behavioral: Lifestyle counseling |
| Group 2 | Active comparator | Lifestyle counseling without Positive Airway Pressure (PAP) therapy Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Change
Month 6 change in HbA1c (%)
Measured: Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- 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
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal North Shore Hospital, Baker Heart and Diabetes Institute, International Diabetes Center at Park Nicollet
- Responsible party
- Sponsor
- Investigators
- Paul Zimmet, MBBS MD PhD, Study chair, International Diabetes Institute, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509223
- Sponsor's protocol ID
- CA-09-06-01
- Status last verified
- Dec 2013
- First submitted
- 29 Jul 2007
- Last updated
- 30 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shaw JE, Punjabi NM, Naughton MT, Willes L, Bergenstal RM, Cistulli PA, Fulcher GR, Richards GN, Zimmet PZ. The Effect of Treatment of Obstructive Sleep Apnea on Glycemic Control in Type 2 Diabetes. Am J Respir Crit Care Med. 2016 Aug 15;194(4):486-92. doi: 10.1164/rccm.201511-2260OC.
PubMed 26926656
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00509223
- Acronym / sponsor ID
- CA-09-06-01
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- Type 2 diabetes, Obstructive sleep apnea, Glycemic control, Insulin resistance, Sleep disordered breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- Royal North Shore Hospital, Baker Heart and Diabetes Institute, International Diabetes Center at Park Nicollet
- Study start
- Jul 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 31 Jul 2007 (estimated)
- Results
- Posted 17 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive Sleep Apnea (OSA) and type 2 diabetes mellitus are two prevalent medical conditions with significant associated cardiovascular and cerebrovascular morbidity and mortality. Research indicates that the prevalence of OSA is increased in diabetic patients when compared with normoglycemic patients and that OSA is independently associated with type 2 diabetes. Further research suggests that effective treatment of the OSA with continuous positive airway pressure (CPAP) improves insulin responsiveness in both non-diabetic OSA patients and diabetic-OSA patients. We are proposing a clinical trial to evaluate the impact of 6 months of CPAP therapy on glycemic control in type 2 diabetic patients with OSA.
The primary objective of this study is to assess the effectiveness of CPAP in improving glycemic control (HbA1c) in type 2 diabetic patients with newly diagnosed OSA. Secondary objectives of this study include: assessment of fasting and post prandial glucose, determination as to whether there are any biochemical markers for OSA in the type 2 diabetic population; assessment of any improvements in cardiovascular outcomes; evaluation of any improvement in quality of life. Patients with OSA will be randomized into one of two groups: either a CPAP treatment group or a non-treatment group. Patients will be followed at 3 months and 6 months with collection of various lab tests to assess glycemic control.
Detailed description
Patients attending clinical sites involved with the trial will be asked to participate in the study. Patients will undergo a sleep test and if positive for Obstructive Sleep Apnea (OSA) will continue in the study.
At the time of enrolment baseline history and physical examination will be assessed. Baseline lab samples will also be obtained to measure levels of fasting blood glucose, insulin, HbA1c, lipids, biochemical markers and creatinine/albumin ratio. Post-prandial glucose levels and 24-hour ambulatory blood pressure will be evaluated. Participants will also be asked to complete Quality of Life (QoL) questionnaires.
Participants will be randomised into either continuous positive airway pressure CPAP treatment or no treatment. All subjects will be counselled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations. Follow-up on adoption of the healthy lifestyle approach will be done for all study participants for the duration of the trial period. Total duration of a patient's participation is 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Positive Airway Pressure therapy, Behavioral: Lifestyle counselingLifestyle counseling with Positive Airway Pressure (PAP) therapy |
| Group 2 | Active comparator | Behavioral: Lifestyle counselingLifestyle counseling without Positive Airway Pressure (PAP) therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older,
- Known diagnosis of type 2 diabetes for at least 3 months
- HbA1c >6.5% and </= 8.5%
- BMI </= 40 kg/m2
Key exclusion criteria (8 listed)
- Requires oxygen therapy
- OSA is severe (AHI>70 or SaO2<70%)
- Work in transport related industries
- Previous diagnosis of OSA
- Known MVA due to sleepiness in the previous 5 years
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 |
|---|---|---|
| Positive Airway Pressure therapyAlso: ResMed AutoSet S8Positive Airway Pressure (PAP) therapy initiated at Randomization and continued through the entire study duration (6 months), with instructions for use on a daily basis, during periods of sleep. | Device | Group 1 |
| Lifestyle counselingLifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations. | Behavioural | Group 1, Group 2 |
Primary outcome
HbA1c Change
Time frame: Baseline to Month 6
Month 6 change in HbA1c (%)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26926656Shaw JE, Punjabi NM, Naughton MT, Willes L, Bergenstal RM, Cistulli PA, Fulcher GR, Richards GN, Zimmet PZ. The Effect of Treatment of Obstructive Sleep Apnea on Glycemic Control in Type 2 Diabetes. Am J Respir Crit Care Med. 2016 Aug 15;194(4):486-92. doi: 10.1164/rccm.201511-2260OC.
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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.
Paul Zimmet, MBBS MD PhD study chair
International Diabetes Institute, Australia
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Airway Pressure therapy and Lifestyle counseling in people with Diabetes Mellitus Type 2, run by ResMed at 15 sites in 3 countries.
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 4 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: finished, as of the sponsor's last update on 30 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Australia, Canada. 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?
Yes. Results are posted in the registry (first posted 17 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
HbA1c Change (time frame: Baseline to Month 6). 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 NCT00509223, 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 30 Dec 2013.