Clinical trial NCT00509223: GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes
Official title: Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes and Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: Type 2 diabetes
Obstructive sleep apnea
Glycemic control
Insulin resistance
Sleep disordered breathing
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: Royal North Shore Hospital
name: Baker Heart and Diabetes Institute
name: International Diabetes Center at Park Nicollet
First posted: 2007-07-31
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c Change
timeFrame: Baseline to Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Mission Internal Medical Group
state: California
city: Temecula
country: United States
facility: Advanced Metabolic Care and Research Institute
state: California
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Macon
country: United States
facility: SleepMed of Central Georgia
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: St Louis Park
country: United States
facility: International Diabetes Center
state: Minnesota
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Columbus
country: United States
facility: OSU Sleep Medicine Program
state: Ohio
city: Charleston
country: United States
facility: SleepMed of West Ashley
state: South Carolina
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
city: San Antonio
country: United States
facility: Cetero Research
state: Texas
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Box Hill
country: Australia
facility: Eastern Clinical Research Unit
state: Victoria
city: Melbourne
country: Australia
facility: Baker IDI Heart and Diabetes Institute
state: Victoria
city: Quebec City
country: Canada
facility: IUCPQ
state: Quebec
Study officials:
affiliation: International Diabetes Institute, Australia
name: Paul Zimmet, MBBS MD PhD
role: STUDY_CHAIR
References:
citation: 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.