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N/A Completed N=416 Randomized Treatment

GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes

Source: ClinicalTrials.gov NCT00509223 ↗
Enrolled (actual)
416
Serious AEs
5.0%
Results posted
Oct 2013
Primary outcomePrimary: HbA1c Change — -0.1; -0.1 HbA1c percent

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
HbA1c Change
-0.1; -0.1

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older,
  • Known diagnosis of type 2 diabetes for at least 3 months
  • HbA1c >6.5% and 70 or SaO2 6 months but weight not stable
  • Unstable angina
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00509223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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