GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes
NCT ID: NCT00509223
Last Updated: 2013-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
416 participants
INTERVENTIONAL
2007-07-31
2012-02-29
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Lifestyle counseling with Positive Airway Pressure (PAP) therapy
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.
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.
Group 2
Lifestyle counseling without Positive Airway Pressure (PAP) therapy
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Royal North Shore Hospital
OTHER
Baker Heart and Diabetes Institute
OTHER
International Diabetes Center at Park Nicollet
OTHER
ResMed
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Zimmet, MBBS MD PhD
Role: STUDY_CHAIR
International Diabetes Institute, Australia
Locations
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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
Countries
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References
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Shaw JE, Punjabi NM, Naughton MT, Willes L, Bergenstal RM, Cistulli PA, Fulcher GR, Richards GN, Zimmet PZ. The Effect of Treatment of Obstructive Sleep Apnea on Glycemic Control in Type 2 Diabetes. Am J Respir Crit Care Med. 2016 Aug 15;194(4):486-92. doi: 10.1164/rccm.201511-2260OC.
Other Identifiers
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CA-09-06-01
Identifier Type: -
Identifier Source: org_study_id