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| Name | Class |
|---|---|
| Royal North Shore Hospital | OTHER |
| Baker Heart and Diabetes Institute | OTHER |
| International Diabetes Center at Park Nicollet | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Lifestyle counseling with Positive Airway Pressure (PAP) therapy |
|
| Group 2 | Active Comparator | Lifestyle counseling without Positive Airway Pressure (PAP) therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Airway Pressure therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Change | Month 6 change in HbA1c (%) | Baseline to Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Zimmet, MBBS MD PhD | International Diabetes Institute, Australia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mission Internal Medical Group | Mission Viejo | California | 92691 | United States | ||
| Advanced Metabolic Care and Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26926656 | Derived | 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. |
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Subjects were presented with an Informed Consent Form (and HIPAA in USA) and assessed for eligibility based on inclusion /exclusion criteria. If all IEC met, subjects randomized 1:1. 118 subjects not included in endpoint analysis due to reanalysis of Obstructive Sleep Apnea (OSA) inclusion criteria. 298 of the 416 were included for final analysis.
Subjects for this study were recruited from 15 medical clinics located in the United States and Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Lifestyle counseling with Positive Airway Pressure (PAP) therapy 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. Positive Airway Pressure therapy : PAP therapy was initiated at Randomization and continued through the entire study duration (6 months), with instructions for use on a daily basis, during periods of sleep. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Lifestyle counseling | Behavioral | 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. |
|
| Temecula |
| California |
| 92951 |
| United States |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States |
| SleepMed of Central Georgia | Macon | Georgia | 31201 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| International Diabetes Center | Saint Louis Park | Minnesota | 55416 | United States |
| Rochester Clinical Research | Rochester | New York | 14609 | United States |
| OSU Sleep Medicine Program | Columbus | Ohio | 43210 | United States |
| SleepMed of West Ashley | Charleston | South Carolina | 29407 | United States |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | United States |
| Cetero Research | San Antonio | Texas | 78229 | United States |
| Royal North Shore Hospital | Sydney | New South Wales | 2065 | Australia |
| Eastern Clinical Research Unit | Box Hill | Victoria | 3128 | Australia |
| Baker IDI Heart and Diabetes Institute | Melbourne | Victoria | 3004 | Australia |
| IUCPQ | Québec | Quebec | G1V 4G5 | Canada |
| FG001 | Group 2 | Lifestyle counseling without Positive Airway Pressure (PAP) therapy 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. |
| COMPLETED |
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| NOT COMPLETED |
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118 subjects (of the 416 that started in the participant flow module) were not included in endpoint analysis due to reanalysis of OSA inclusion criteria. Thus, 298 of the 416 were included for final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lifestyle Counseling With PAP Therapy | |
| BG001 | Lifestyle Counseling | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HbA1c Change | Month 6 change in HbA1c (%) | The following definition was applied to the primary endpoint: included in analysis were all participants that had at least 1 follow-up HbA1c value in addition to the Baseline HbA1c were considered. | Posted | Mean | Standard Deviation | HbA1c percent | Baseline to Month 6 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lifestyle Counseling | 5 | 147 | 78 | 147 | |||
| EG001 | Lifestyle Counseling With PAP Therapy | 10 | 151 | 94 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Distress | Gastrointestinal disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Procedure | Surgical and medical procedures | Systematic Assessment |
| ||
| TIA / Blockage of Artery | Cardiac disorders | Systematic Assessment |
| ||
| Ovarian Cancer | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Brachial Plexopathy | Nervous system disorders | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI Distress | Gastrointestinal disorders | Systematic Assessment |
| ||
| General Infection | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Nasal Dryness/Irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Skin Irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Shaw, MD, FRACP, FRCP | Baker IDI Heart and Diabetes Institute | +61 (0) 3 8532 1821 | jonathan.shaw@bakeridi.edu.au |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D020181 | Sleep Apnea, Obstructive |
| D007333 | Insulin Resistance |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006946 | Hyperinsulinism |
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| >=65 years |
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| Male |
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| Australia |
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