Effects of Treatment of Sleep Apnea on Metabolic Syndrome
This study has been completed.
Sponsor:
Brigham and Women's Hospital
Collaborators:
Beth Israel Deaconess Medical Center
Case Western Reserve University
Information provided by (Responsible Party):
Susan Redline, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01385995
First received: June 23, 2011
Last updated: July 24, 2012
Last verified: June 2012
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by Brigham and Women's Hospital:
Primary Outcome Measures:
- Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 50 |
| Study Start Date: | January 2004 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385995
Sponsors and Collaborators
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Case Western Reserve University
Investigators
| 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
No publications provided by Brigham and Women's Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Susan Redline, MD, MPH, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01385995 History of Changes |
| Other Study ID Numbers: | HL075077, UL1RR024989 |
| Study First Received: | June 23, 2011 |
| Results First Received: | February 21, 2012 |
| Last Updated: | July 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Glucose Intolerance Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013