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Sponsors and Collaborators: |
ResMed Royal North Shore Hospital(Australia) International Diabetes Institute, Australia |
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Information provided by: | ResMed |
ClinicalTrials.gov Identifier: | NCT00509223 |
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 normoglycaemic 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 glycaemic control in type 2 diabetic patients with OSA. The primary objective of this study is to assess the effectiveness of CPAP in improving glycaemic control (A1c, fasting & post prandial glucose) in type 2 diabetic patients with newly diagnosed OSA. Secondary objectives of this study include: · 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 glycaemic control.
Condition | Intervention |
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Diabetes Mellitus Type 2 |
Device: Positive airway pressure therapy Behavioral: Lifestyle control regarding nutrition and exercise |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of PAP Treatment on Glycaemic Control in Patients With Type 2 Diabetes and Obstructive Sleep Apnea |
Estimated Enrollment: | 230 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | January 2009 |
Arms | Assigned Interventions |
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Group 1: Experimental
PAP therapy with lifestyle control
|
Device: Positive airway pressure therapy
PAP therapy
|
Group 2: Active Comparator
Lifestyle control without PAP therapy
|
Behavioral: Lifestyle control regarding nutrition and exercise |
Patients attending the Diabetic Clinics at Royal North Shore Hospital, Sydney, The International Diabetes Institute and The International Diabetes Center will be asked to participate in the study. Patients will undergo a sleep test followed and if positive for OSA will continue in the study.
At the time of enrolment baseline history and physical examination will be assessed. Baseline lab sampleswill 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 QOL questionnaires.
Participants will be randomised into either CPAP treatment or no treatment. All subjects will be counselled regarding adopting a healthy lifestyle and advised on the Heart Foundation 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 patients' participation is 6 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Glenn Richards, physician | 64 92929119 | glennr@resmed.com |
United States, Minnesota | |
International Diabetes Centre | Recruiting |
St Louis Park, Minnesota, United States, 55416 | |
Contact: Richard Bergenstal, MD 952-993-1913 Richard.Bergenstal@ParkNicollet.com | |
Principal Investigator: Richard Bergenstal, MD | |
Australia, New South Wales | |
Royal North Shore Hospital | Recruiting |
Sydney, New South Wales, Australia, 2065 | |
Contact: Greg Fulcher, MBBS FRACP +61 2 9926 8388 gfulcher@med.usyd.edu.au | |
Contact: Peter Cistulli, MBBS PhD MBA +61 2 9926 7807 cistullip@med.usyd.edu.au | |
Principal Investigator: Greg Fulcher, MBBS FRACP | |
Australia, Victoria | |
International Diabetes Institute | Recruiting |
Melbourne, Victoria, Australia, 3162 | |
Contact: Paul Zimmet, MBBS MD PhD + 61 3 9258 5049 pzimmet@idi.org.au | |
Contact: Jonathan Shaw, MD FRACP + 61 3 9258 5047 jshaw@idi.org.au | |
Principal Investigator: Jonathan Shaw, MD FRACP |
Study Chair: | Paul Zimmet, MBBS MD PhD | International Diabetes Institute, Australia |
Study ID Numbers: | CA-09-06-01 |
Study First Received: | July 29, 2007 |
Last Updated: | August 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00509223 |
Health Authority: | Australia: Human Research Ethics Committee; United States: Institutional Review Board |
Type 2 diabetes Obstructive sleep apnea glycaemic control insulin resistance sleep disordered breathing |
Sleep Apnea Syndromes Metabolic Diseases Apnea Sleep Apnea, Obstructive Respiration Disorders Diabetes Mellitus Dyssomnias Endocrine System Diseases Sleep Disorders |
Insulin Sleep Disorders, Intrinsic Respiratory Tract Diseases Diabetes Mellitus, Type 2 Endocrinopathy Insulin Resistance Metabolic disorder Glucose Metabolism Disorders |
Nervous System Diseases |