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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Device: Positive Airway Pressure therapy; Behavioral: Lifestyle counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c Change	Month 6 change in HbA1c (%)	Baseline to Month 6

Collaborators and Investigators

• Sponsor: ResMed
• Collaborators: Royal North Shore Hospital; International Diabetes Center at Park Nicollet; Baker Heart and Diabetes Institute
• Investigators: Study Chair: Paul Zimmet, MBBS MD PhD, International Diabetes Institute, Australia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: July 29, 2007
• First Submitted That Met QC Criteria: July 29, 2007
• First Posted (Estimate): July 31, 2007

Study Record Updates

• Last Update Posted (Estimate): December 30, 2013
• Last Update Submitted That Met QC Criteria: December 4, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Insulin resistance; Obstructive sleep apnea; Type 2 diabetes; Sleep disordered breathing; Glycemic control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CA-09-06-01