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

This study has been completed.
Sponsor:
Collaborators:
Royal North Shore Hospital
Baker IDI Heart and Diabetes Institute
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT00509223
First received: July 29, 2007
Last updated: December 4, 2013
Last verified: December 2013

July 29, 2007
December 4, 2013
July 2007
February 2012   (final data collection date for primary outcome measure)
HbA1c Change [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
Month 6 change in HbA1c (%)
Assessment of the effectiveness of CPAP in improving glycaemic control in type 2 diabetic patients with newly diagnosed OSA. [ Time Frame: 18 months ]
Complete list of historical versions of study NCT00509223 on ClinicalTrials.gov Archive Site
Not Provided
  • Assessment of any improvements in cardiovascular outcomes eg: decrease in BP following PAP therapy [ Time Frame: 18 months ]
  • Evaluation of any improvement in quality of life [ Time Frame: 18 months ]
  • Determination as to whether there are any biochemical markers for OSA in the type 2 diabetic population. [ Time Frame: 18 months ]
Not Provided
Not Provided
 
GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Device: Positive Airway Pressure therapy
    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.
    Other Name: ResMed AutoSet S8
  • Behavioral: Lifestyle counseling
    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.
  • Experimental: Group 1
    Lifestyle counseling with Positive Airway Pressure (PAP) therapy
    Interventions:
    • Device: Positive Airway Pressure therapy
    • Behavioral: Lifestyle counseling
  • Active Comparator: Group 2
    Lifestyle counseling without Positive Airway Pressure (PAP) therapy
    Intervention: Behavioral: Lifestyle counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
416
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 18 years of age or older,
  2. Known diagnosis of type 2 diabetes for at least 3 months
  3. HbA1c >6.5% and </= 8.5%
  4. BMI </= 40 kg/m2

Exclusion Criteria:

  1. Requires oxygen therapy
  2. OSA is severe (AHI>70 or SaO2<70%)
  3. Work in transport related industries
  4. Previous diagnosis of OSA
  5. Known MVA due to sleepiness in the previous 5 years
  6. Insulin-requiring
  7. Use of GLP-1 mimetic (e.g. Byetta) for < 6 months or > 6 months but weight not stable
  8. Unstable angina
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00509223
CA-09-06-01
No
ResMed
ResMed
  • Royal North Shore Hospital
  • Baker IDI Heart and Diabetes Institute
  • International Diabetes Center at Park Nicollet
Study Chair: Paul Zimmet, MBBS MD PhD International Diabetes Institute, Australia
ResMed
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP