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

This study has been completed.
Sponsor:
Collaborators:
Royal North Shore Hospital
Baker IDI Heart and Diabetes Institute
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT00509223
First received: July 29, 2007
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus Type 2
Device: Positive Airway Pressure therapy
Behavioral: Lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes and Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by ResMed:

Primary Outcome Measures:
  • HbA1c Change [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Month 6 change in HbA1c (%)


Enrollment: 416
Study Start Date: July 2007
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Lifestyle counseling with Positive Airway Pressure (PAP) therapy
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.
Other Name: ResMed AutoSet S8
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.
Active Comparator: Group 2
Lifestyle counseling without Positive Airway Pressure (PAP) therapy
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509223

Locations
United States, California
Mission Internal Medical Group
Mission Viejo, California, United States, 92691
Advanced Metabolic Care and Research Institute
Temecula, California, United States, 92951
United States, Florida
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
United States, Georgia
SleepMed of Central Georgia
Macon, Georgia, United States, 31201
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Minnesota
International Diabetes Center
St Louis Park, Minnesota, United States, 55416
United States, New York
Rochester Clinical Research
Rochester, New York, United States, 14609
United States, Ohio
OSU Sleep Medicine Program
Columbus, Ohio, United States, 43210
United States, South Carolina
SleepMed of West Ashley
Charleston, South Carolina, United States, 29407
SleepMed of South Carolina
Columbia, South Carolina, United States, 29201
United States, Texas
Cetero Research
San Antonio, Texas, United States, 78229
Australia, New South Wales
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Australia, Victoria
Eastern Clinical Research Unit
Box Hill, Victoria, Australia, 3128
Baker IDI Heart and Diabetes Institute
Melbourne, Victoria, Australia, 3004
Canada, Quebec
IUCPQ
Quebec City, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
ResMed
Royal North Shore Hospital
Baker IDI Heart and Diabetes Institute
International Diabetes Center at Park Nicollet
Investigators
Study Chair: Paul Zimmet, MBBS MD PhD International Diabetes Institute, Australia
  More Information

No publications provided

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT00509223     History of Changes
Other Study ID Numbers: CA-09-06-01
Study First Received: July 29, 2007
Results First Received: August 8, 2013
Last Updated: December 4, 2013
Health Authority: Australia: Human Research Ethics Committee
United States: Institutional Review Board
Canada: Ethics Review Committee

Keywords provided by ResMed:
Type 2 diabetes
Obstructive sleep apnea
Glycemic control
Insulin resistance
Sleep disordered breathing

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Sleep Apnea, Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014