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NCT00509223 · ClinicalTrials.gov registry record · NA
GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes
A NA study, sponsored by ResMed.
- Completed
- Registry status
- NA
- Development phase
- 416
- Enrollment target
NCT00509223 is a NA study that has completed, run by ResMed. The registered enrollment target is 416 participants.
The verdict
NCT00509223, a NA study, has completed, sponsored by ResMed.
- COMPLETED
- Registry status
- NA
- Development phase
- 416 participants
- Enrollment target
Study Summary
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.
Interventions
- BEHAVIORAL Lifestyle counseling
- DEVICE Positive Airway Pressure therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 416 participants |
| Start Date | 2007-07 |
| Est. Completion | 2012-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00509223
The ClinicalTrials.gov registry entry for NCT00509223 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 416 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ResMed, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lifestyle counseling is the first listed.
NCT00509223 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00509223 about?
NCT00509223 is a clinical study titled "GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes". 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 pat...
What is the current status of trial NCT00509223?
This trial is currently completed. It is a NA study. The enrollment target is 416 participants. The study started on 2007-07. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00509223?
The interventions under investigation include: Lifestyle counseling (BEHAVIORAL), Positive Airway Pressure therapy (DEVICE).
Who is sponsoring clinical trial NCT00509223?
This trial is sponsored by ResMed, which has 25 total clinical trials registered on ClinicalTrials.gov.
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