GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes
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Purpose
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 | Intervention |
|---|---|
|
Diabetes Mellitus Type 2 |
Device: Positive Airway Pressure therapy Behavioral: Lifestyle counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes and Obstructive Sleep Apnea |
- HbA1c Change [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]Month 6 change in HbA1c (%)
| Enrollment: | 416 |
| Study Start Date: | July 2007 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Lifestyle counseling with Positive Airway Pressure (PAP) therapy
|
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.
|
|
Active Comparator: Group 2
Lifestyle counseling without Positive Airway Pressure (PAP) therapy
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| Responsible Party: | ResMed |
| ClinicalTrials.gov Identifier: | NCT00509223 History of Changes |
| Other Study ID Numbers: | CA-09-06-01 |
| Study First Received: | July 29, 2007 |
| Results First Received: | August 8, 2013 |
| Last Updated: | December 4, 2013 |
| Health Authority: | Australia: Human Research Ethics Committee United States: Institutional Review Board Canada: Ethics Review Committee |
Keywords provided by ResMed:
|
Type 2 diabetes Obstructive sleep apnea Glycemic control Insulin resistance Sleep disordered breathing |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Sleep Apnea, Obstructive Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sleep Apnea Syndromes |
Apnea Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on September 23, 2016