Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
BEHAVIORAL - 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.

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.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
BEHAVIORAL
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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00509223