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
About this trial
This is an interventional treatment trial for Impaired Glucose Tolerance
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
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
NCT ID
NCT01385995
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
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
Learn more about this trial
Effects of Treatment of Sleep Apnea on Metabolic Syndrome
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