GLYCOSA Study:Effect of PAP Treatment on Glycaemic Control in Patients With Type 2 Diabetes - Clinical Trials for Diabetes and Sleep Apnea

GLYCOSA Study:Effect of PAP Treatment on Glycaemic Control in Patients With Type 2 Diabetes
ClinicalTrials.gov

This study is currently recruiting participants.

Verified by ResMed, August 2007
Sponsors and Collaborators: ResMed Royal North Shore Hospital(Australia) International Diabetes Institute, Australia

Information provided by: ResMed

ClinicalTrials.gov Identifier: NCT00509223

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 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
Diabetes Mellitus Type 2 Device: Positive airway pressure therapy
Behavioral: Lifestyle control regarding nutrition
and exercise

MedlinePlus related topics: Diabetes Sleep Apnea
Drug Information available for: Insulin
U.S. FDA Resources
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

Further study details as provided by ResMed:

Primary Outcome Measures:
* Assessment of the effectiveness of CPAP in improving glycaemic control in type 2 diabetic patients with newly diagnosed OSA. [ Time Frame: 18 months ]

Secondary Outcome Measures:
* Assessment of any improvements in cardiovascular outcomes [ Time Frame: 18 months ]
* Evaluation of any improvement in quality of life [ Time Frame: 18 months ]
* Determination as to whether there are any biochemical markers for OSA in the type 2 diabetic population. [ Time Frame: 18 months ]

Estimated Enrollment: 230
Study Start Date: July 2007
Estimated Study Completion Date: January 2009
Arms Assigned Interventions
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

Detailed Description:
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.

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,
3. AHI>15
4. willing and able to complete specified follow-up evaluations.

Exclusion Criteria:

1. OSA is severe (AHI>70, SaO2<70%).
2. work in transport related industries.
3. previous diagnosis of OSA.
4. known MVA due to sleepiness in the previous 5 years .
5. insulin-requiring
6. HbA1c is < 6.5% or > 8.5%.
7. unstable angina or unstable hypertension.
8. the investigator considers they are unsuitable for inclusion.

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

Contacts
Contact: Glenn Richards, physician 64 92929119 glennr@resmed.com

Locations
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
Sponsors and Collaborators
ResMed
Royal North Shore Hospital(Australia)
International Diabetes Institute, Australia
Investigators
Study Chair: Paul Zimmet, MBBS MD PhD International Diabetes Institute, Australia
More Information

Study ID Numbers: CA-09-06-01
Study First Received: July 29, 2007
Last Updated: August 16, 2007
ClinicalTrials.gov Identifier: NCT00509223 [history]
Health Authority: Australia: Human Research Ethics Committee; United States: Institutional Review Board

Keywords provided by ResMed:
Type 2 diabetes
Obstructive sleep apnea
glycaemic control
insulin resistance
sleep disordered breathing

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009