Diabetes Mellitus Type 2 Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01267448 -
Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia
|
Phase 4 | |
| Active, not recruiting |
NCT05330247 -
Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study
|
N/A | |
| Terminated |
NCT02743598 -
Liraglutide for HIV-associated Neurocognitive Disorder
|
Phase 4 | |
| Terminated |
NCT02373865 -
Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT01741181 -
Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2
|
Phase 4 | |
| Completed |
NCT01305434 -
Mulberry Leaf Extract and Blood Glucose Control in Diabetics
|
Phase 1/Phase 2 | |
| Completed |
NCT01330121 -
Bridging the Gap by Transitional Care
|
N/A | |
| Recruiting |
NCT00992797 -
Diabetes Intervention Trial With Vitamin D in Subjects of Nordic and Sub-Indian Ethnicity
|
Phase 2 | |
| Completed |
NCT01580904 -
Impact of Pharmaceutical Care in Diabetics Patients
|
N/A | |
| Active, not recruiting |
NCT00728403 -
Metabolic and Therapeutic Effects of American and Korean Red Ginseng in the Treatment of Type 2 Diabetes
|
Phase 2 | |
| Completed |
NCT00763815 -
GLP-1 Receptor Agonist Lixisenatide in Patients With Type 2 Diabetes for Glycemic Control and Safety Evaluation, on Top of Pioglitazone
|
Phase 3 | |
| Active, not recruiting |
NCT00529815 -
Continuous Glucose Monitoring in Patients With Type 2 Diabetes
|
Phase 4 | |
| Completed |
NCT00517465 -
A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.
|
Phase 1 | |
| Completed |
NCT00119041 -
Diabetes Telemedicine Consultation: A Systems Improvement Intervention
|
N/A | |
| Withdrawn |
NCT00417716 -
Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema
|
Phase 3 | |
| Withdrawn |
NCT00600236 -
HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population
|
Phase 3 | |
| Active, not recruiting |
NCT05887635 -
Study of Duodenal Mucosal RF Vapor Ablation in Subjects With Type-2 Diabetes Mellitus
|
N/A | |
| Completed |
NCT03903965 -
Comparison of Retinal Perfusion Between Diabetic and Non-diabetic Patients With OCT Angiography After Cataract Surgery.
|
||
| Completed |
NCT02666924 -
Cooking Classes for Chinese Canadian Patients Living With Diabetes
|
N/A | |
| Recruiting |
NCT02501850 -
The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a)
|
Phase 4 |