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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00509223




Registration number
NCT00509223
Ethics application status
Date submitted
29/07/2007
Date registered
31/07/2007
Date last updated
30/12/2013

Titles & IDs
Public title
GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes
Scientific title
Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes and Obstructive Sleep Apnea
Secondary ID [1] 0 0
CA-09-06-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Positive Airway Pressure therapy
Behaviour - Lifestyle counseling

Experimental: Group 1 - Lifestyle counseling with Positive Airway Pressure (PAP) therapy

Active Comparator: Group 2 - Lifestyle counseling without Positive Airway Pressure (PAP) therapy


Treatment: Devices: 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.

Behaviour: 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.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c Change
Timepoint [1] 0 0
Baseline to Month 6

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
Accrual to date
Final
416
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [2] 0 0
Eastern Clinical Research Unit - Box Hill
Recruitment hospital [3] 0 0
Baker IDI Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal North Shore Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Baker Heart and Diabetes Institute
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
International Diabetes Center at Park Nicollet
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00509223
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Zimmet, MBBS MD PhD
Address 0 0
International Diabetes Institute, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries