GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes
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| ClinicalTrials.gov Identifier: NCT00509223 |
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Recruitment Status :
Completed
First Posted : July 31, 2007
Results First Posted : October 17, 2013
Last Update Posted : December 30, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus Type 2 | Device: Positive Airway Pressure therapy Behavioral: Lifestyle counseling | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 416 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes and Obstructive Sleep Apnea |
| Study Start Date : | July 2007 |
| Actual Primary Completion Date : | February 2012 |
| Actual Study Completion Date : | February 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1
Lifestyle counseling with Positive Airway Pressure (PAP) therapy
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Device: Positive Airway Pressure therapy
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.
Other Name: ResMed AutoSet S8 Behavioral: Lifestyle counseling 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. |
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Active Comparator: Group 2
Lifestyle counseling without Positive Airway Pressure (PAP) therapy
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Behavioral: Lifestyle counseling
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. |
- HbA1c Change [ Time Frame: Baseline to Month 6 ]Month 6 change in HbA1c (%)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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): NCT00509223
| United States, California | |
| Mission Internal Medical Group | |
| Mission Viejo, California, United States, 92691 | |
| Advanced Metabolic Care and Research Institute | |
| Temecula, California, United States, 92951 | |
| United States, Florida | |
| Clinical Research of South Florida | |
| Coral Gables, Florida, United States, 33134 | |
| United States, Georgia | |
| SleepMed of Central Georgia | |
| Macon, Georgia, United States, 31201 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21224 | |
| United States, Minnesota | |
| International Diabetes Center | |
| St Louis Park, Minnesota, United States, 55416 | |
| United States, New York | |
| Rochester Clinical Research | |
| Rochester, New York, United States, 14609 | |
| United States, Ohio | |
| OSU Sleep Medicine Program | |
| Columbus, Ohio, United States, 43210 | |
| United States, South Carolina | |
| SleepMed of West Ashley | |
| Charleston, South Carolina, United States, 29407 | |
| SleepMed of South Carolina | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Texas | |
| Cetero Research | |
| San Antonio, Texas, United States, 78229 | |
| Australia, New South Wales | |
| Royal North Shore Hospital | |
| Sydney, New South Wales, Australia, 2065 | |
| Australia, Victoria | |
| Eastern Clinical Research Unit | |
| Box Hill, Victoria, Australia, 3128 | |
| Baker IDI Heart and Diabetes Institute | |
| Melbourne, Victoria, Australia, 3004 | |
| Canada, Quebec | |
| IUCPQ | |
| Quebec City, Quebec, Canada, G1V 4G5 | |
| Study Chair: | Paul Zimmet, MBBS MD PhD | International Diabetes Institute, Australia |
| Responsible Party: | ResMed |
| ClinicalTrials.gov Identifier: | NCT00509223 |
| Other Study ID Numbers: |
CA-09-06-01 |
| First Posted: | July 31, 2007 Key Record Dates |
| Results First Posted: | October 17, 2013 |
| Last Update Posted: | December 30, 2013 |
| Last Verified: | December 2013 |
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Type 2 diabetes Obstructive sleep apnea Glycemic control Insulin resistance Sleep disordered breathing |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |