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Effects of Treatment of Sleep Apnea on Metabolic Syndrome

Primary Purpose

Impaired Glucose Tolerance, Obstructive Sleep Apnea

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)
Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impaired Glucose Tolerance

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Continuous Positive Airway Pressure (CPAP)

    Sham-Continuous Positive Airway Pressure (CPAP)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT)
    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

    Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham
    Reported values include: fasting glucose (mg/dL), 2 hour Oral Glucose Tolerance Test (OGTT) (mg/dL)
    Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham
    The data for fasting and 2 hour Insulin (iIU/dL) are presented according to therapeutic CPAP vs. Sham CPAP.
    Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham
    Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) with therapeutic CPAP vs. Sham CPAP
    Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham
    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.

    Full Information

    First Posted
    June 23, 2011
    Last Updated
    February 10, 2014
    Sponsor
    Brigham and Women's Hospital
    Collaborators
    National Institutes of Health (NIH), National Center for Research Resources (NCRR), Beth Israel Deaconess Medical Center, Case Western Reserve University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01385995
    Brief Title
    Effects of Treatment of Sleep Apnea on Metabolic Syndrome
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2004 (undefined)
    Primary Completion Date
    September 2008 (Actual)
    Study Completion Date
    September 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital
    Collaborators
    National Institutes of Health (NIH), National Center for Research Resources (NCRR), Beth Israel Deaconess Medical Center, Case Western Reserve University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Impaired Glucose Tolerance, Obstructive Sleep Apnea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Continuous Positive Airway Pressure (CPAP)
    Arm Type
    Active Comparator
    Arm Title
    Sham-Continuous Positive Airway Pressure (CPAP)
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)
    Other Intervention Name(s)
    Philips-Respironics RemStar Pro® CPAP
    Intervention Description
    Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.
    Intervention Type
    Device
    Intervention Name(s)
    Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)
    Other Intervention Name(s)
    Philips-Respironics Sham CPAP
    Intervention Description
    Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.
    Primary Outcome Measure Information:
    Title
    Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT)
    Description
    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)
    Time Frame
    20 weeks
    Secondary Outcome Measure Information:
    Title
    Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham
    Description
    Reported values include: fasting glucose (mg/dL), 2 hour Oral Glucose Tolerance Test (OGTT) (mg/dL)
    Time Frame
    20 weeks
    Title
    Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham
    Description
    The data for fasting and 2 hour Insulin (iIU/dL) are presented according to therapeutic CPAP vs. Sham CPAP.
    Time Frame
    20 weeks
    Title
    Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham
    Description
    Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) with therapeutic CPAP vs. Sham CPAP
    Time Frame
    20 weeks
    Title
    Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham
    Description
    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.
    Time Frame
    20 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susan Redline, M.D., M.P.H.
    Organizational Affiliation
    Brigham and Women's Hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Faramarz Beigi
    Organizational Affiliation
    Case Western Reserve University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    H Lester Kirchner, PhD
    Organizational Affiliation
    Case Western Reserve University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Carol Rosen, M.D.
    Organizational Affiliation
    Case Western Reserve University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    John Haaga, M.D.
    Organizational Affiliation
    Case Western Reserve University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kingman Strohl, M.D.
    Organizational Affiliation
    Case Western Reserve University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Reena Mehra, M.S., M.S.
    Organizational Affiliation
    Case Western Reserve University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Denise Babineau, PhD
    Organizational Affiliation
    Case Western Reserve University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Tanya Weinstock, M.D.
    Organizational Affiliation
    Brigham and Women's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22547887
    Citation
    Weinstock TG, Wang X, Rueschman M, Ismail-Beigi F, Aylor J, Babineau DC, Mehra R, Redline S. A controlled trial of CPAP therapy on metabolic control in individuals with impaired glucose tolerance and sleep apnea. Sleep. 2012 May 1;35(5):617-625B. doi: 10.5665/sleep.1816.
    Results Reference
    derived

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    Effects of Treatment of Sleep Apnea on Metabolic Syndrome

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