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Effects of Treatment of Sleep Apnea on Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01385995
Recruitment Status : Completed
First Posted : June 30, 2011
Results First Posted : July 26, 2012
Last Update Posted : March 12, 2014
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Beth Israel Deaconess Medical Center
Case Western Reserve University
Information provided by (Responsible Party):
Susan Redline, Brigham and Women's Hospital

Study Description
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Brief Summary:
The investigators performed a randomized, cross-over controlled clinical trial comparing 8 weeks of Continuous Positive Airway Pressure (CPAP) to 8 weeks of sham-CPAP in patients with moderate to severe Sleep Disordered Breathing (SDB) and impaired glucose tolerance. A rigorous assessment of metabolic responses to SDB treatment in this group is of great clinical significance because this sample is at high risk for developing diabetes. The paradigm shift of CPAP as a mode of prevention can affect clinical practice in the fields of both primary care and sleep medicine.

Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance Obstructive Sleep Apnea Device: Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP) Device: Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics) Phase 2

Detailed Description:
There are few controlled studies that address whether treatment of sleep apnea improves glucose tolerance. This is a randomized, double-blind cross-over study of subjects with sleep apnea (apnea hypopnea index > 15) and impaired glucose tolerance. Subjects will be randomized to 8 weeks of Continuous Positive Airway Pressure (CPAP) or sham-CPAP, followed by the alternate therapy after a one month wash-out. After each treatment, subjects will undergo 2-hour oral glucose tolerance testing, polysomnography, actigraphy, and measurements of indices of glucose control. The investigators intend to analyze the changes in glucose metabolism and insulin sensitivity in patients with sleep apnea with CPAP intervention.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Trial of Continuous Positive Airway Pressure (CPAP) Therapy on Metabolic Control in Individuals With Impaired Glucose Tolerance and Sleep Apnea
Study Start Date : January 2004
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Continuous Positive Airway Pressure (CPAP) Device: Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)
Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.
Other Name: Philips-Respironics RemStar Pro® CPAP
Sham Comparator: Sham-Continuous Positive Airway Pressure (CPAP) Device: Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)
Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.
Other Name: Philips-Respironics Sham CPAP


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT) [ Time Frame: 20 weeks ]
    Number of subjects who experienced normalization of the mean 2-hour oral glucose tolerance test (OGTT) in the overall sample undergoing therapeutic CPAP vs. sham CPAP. (2-hour OGTT glucose< 140 mg/dL)


Secondary Outcome Measures :
  1. Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham [ Time Frame: 20 weeks ]
    Reported values include: fasting glucose (mg/dL), 2 hour Oral Glucose Tolerance Test (OGTT) (mg/dL)

  2. Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham [ Time Frame: 20 weeks ]
    The data for fasting and 2 hour Insulin (iIU/dL) are presented according to therapeutic CPAP vs. Sham CPAP.

  3. Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham [ Time Frame: 20 weeks ]
    Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) with therapeutic CPAP vs. Sham CPAP

  4. Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham [ Time Frame: 20 Weeks ]
    Insulin Sensitivity Index derived from the Gutt Index, uses the plasma glucose and insulin concentration from fasting (0 min) and 120-min samples from the OGTT, to calculate (Metabolic Clearance Rate)/log (Mean Serum Insulin). The range of possible values is based on the subset ranges of fasting and oral glucose tolerance test (OGTT) insulin and fasting and OGTT glucose, which calculate to be a range of 1.6 to 206.8. An increase in the ISI (0,120) indicates an improvement in the insulin sensitivity.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate to severe Sleep Disordered Breathing (SDB) defined by an Apnea Hypopnea Index (AHI) > 15
  • had evidence of Impaired Glucose Tolerance (IGT) defined by the mean 2-hour Oral Glucose Tolerance Test (OGTT) glucose of > 140 mg/dl calculated from the two 2-hour OGTTs performed within 3 days of each other
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385995


Sponsors and Collaborators
Brigham and Women's Hospital
National Institutes of Health (NIH)
National Center for Research Resources (NCRR)
Beth Israel Deaconess Medical Center
Case Western Reserve University
Investigators
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Study Director: Susan Redline, M.D., M.P.H. Brigham and Women's Hospital
Principal Investigator: Faramarz Beigi Case Western Reserve University
Principal Investigator: H Lester Kirchner, PhD Case Western Reserve University
Principal Investigator: Carol Rosen, M.D. Case Western Reserve University
Principal Investigator: John Haaga, M.D. Case Western Reserve University
Principal Investigator: Kingman Strohl, M.D. Case Western Reserve University
Principal Investigator: Reena Mehra, M.S., M.S. Case Western Reserve University
Principal Investigator: Denise Babineau, PhD Case Western Reserve University
Principal Investigator: Tanya Weinstock, M.D. Brigham and Women's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Susan Redline, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01385995    
Other Study ID Numbers: HL075077
UL1RR024989 ( U.S. NIH Grant/Contract )
First Posted: June 30, 2011    Key Record Dates
Results First Posted: July 26, 2012
Last Update Posted: March 12, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Glucose Intolerance
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases