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

Completed · Not applicable

Conditions studied: Diabetes Mellitus Type 2

In brief

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.

Key facts

Study ID

NCT00509223

Run by

ResMed

People needed

416

Starts

2007-07-01

Expected to finish

2012-02-01

Last updated by the study team

2013-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mission Internal Medical Group — Mission Viejo, California, United States
• Advanced Metabolic Care and Research Institute — Temecula, California, United States
• Clinical Research of South Florida — Coral Gables, Florida, United States
• SleepMed of Central Georgia — Macon, Georgia, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• International Diabetes Center — Saint Louis Park, Minnesota, United States
• Rochester Clinical Research — Rochester, New York, United States
• OSU Sleep Medicine Program — Columbus, Ohio, United States
• SleepMed of West Ashley — Charleston, South Carolina, United States
• SleepMed of South Carolina — Columbia, South Carolina, United States
• Cetero Research — San Antonio, Texas, United States
• Royal North Shore Hospital — Sydney, New South Wales, Australia
• Eastern Clinical Research Unit — Box Hill, Victoria, Australia
• Baker IDI Heart and Diabetes Institute — Melbourne, Victoria, Australia
• IUCPQ — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.