GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes and Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00509223
• Other study ID #: CA-09-06-01
• Status: Completed
• Phase: N/A
• First received: July 29, 2007
• Last updated: December 4, 2013
• Start date: July 2007
• Est. completion date: February 2012

Study information

• Verified date: December 2013
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeUnited States: Institutional Review BoardCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Sleep Apnea, Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Australia	Eastern Clinical Research Unit	Box Hill	Victoria
Australia	Baker IDI Heart and Diabetes Institute	Melbourne	Victoria
Australia	Royal North Shore Hospital	Sydney	New South Wales
Canada	IUCPQ	Quebec City	Quebec
United States	Johns Hopkins University	Baltimore	Maryland
United States	SleepMed of West Ashley	Charleston	South Carolina
United States	SleepMed of South Carolina	Columbia	South Carolina
United States	OSU Sleep Medicine Program	Columbus	Ohio
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	SleepMed of Central Georgia	Macon	Georgia
United States	Mission Internal Medical Group	Mission Viejo	California
United States	Rochester Clinical Research	Rochester	New York
United States	Cetero Research	San Antonio	Texas
United States	International Diabetes Center	St Louis Park	Minnesota
United States	Advanced Metabolic Care and Research Institute	Temecula	California

Sponsors (4)

Lead Sponsor	Collaborator
ResMed	Baker IDI Heart and Diabetes Institute, International Diabetes Center at Park Nicollet, Royal North Shore Hospital

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c Change	Month 6 change in HbA1c (%)	Baseline to Month 6	No