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
1 other identifier
interventional
416
3 countries
15
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Jul 2007
Longer than P75 for not_applicable diabetes-mellitus-type-2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 29, 2007
CompletedFirst Posted
Study publicly available on registry
July 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedResults Posted
Study results publicly available
October 17, 2013
CompletedDecember 30, 2013
December 1, 2013
4.6 years
July 29, 2007
August 8, 2013
December 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c Change
Month 6 change in HbA1c (%)
Baseline to Month 6
Study Arms (2)
Group 1
EXPERIMENTALLifestyle counseling with Positive Airway Pressure (PAP) therapy
Group 2
ACTIVE COMPARATORLifestyle counseling without Positive Airway Pressure (PAP) therapy
Interventions
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: 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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
- Royal North Shore Hospitalcollaborator
- Baker Heart and Diabetes Institutecollaborator
- International Diabetes Center at Park Nicolletcollaborator
Study Sites (15)
Mission Internal Medical Group
Mission Viejo, California, 92691, United States
Advanced Metabolic Care and Research Institute
Temecula, California, 92951, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
SleepMed of Central Georgia
Macon, Georgia, 31201, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
International Diabetes Center
Saint Louis Park, Minnesota, 55416, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
OSU Sleep Medicine Program
Columbus, Ohio, 43210, United States
SleepMed of West Ashley
Charleston, South Carolina, 29407, United States
SleepMed of South Carolina
Columbia, South Carolina, 29201, United States
Cetero Research
San Antonio, Texas, 78229, United States
Royal North Shore Hospital
Sydney, New South Wales, 2065, Australia
Eastern Clinical Research Unit
Box Hill, Victoria, 3128, Australia
Baker IDI Heart and Diabetes Institute
Melbourne, Victoria, 3004, Australia
IUCPQ
Québec, Quebec, G1V 4G5, Canada
Related Publications (1)
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.
PMID: 26926656DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan Shaw, MD, FRACP, FRCP
- Organization
- Baker IDI Heart and Diabetes Institute
Study Officials
- STUDY CHAIR
Paul Zimmet, MBBS MD PhD
International Diabetes Institute, Australia
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2007
First Posted
July 31, 2007
Study Start
July 1, 2007
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
December 30, 2013
Results First Posted
October 17, 2013
Record last verified: 2013-12