Clinical trial NCT01385995: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impaired Glucose Tolerance
Obstructive Sleep Apnea
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Research Resources (NCRR)
name: Beth Israel Deaconess Medical Center
name: Case Western Reserve University
First posted: 2011-06-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT)
timeFrame: 20 weeks
Secondary outcomes:
measure: Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham
timeFrame: 20 weeks
measure: Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham
timeFrame: 20 weeks
measure: Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham
timeFrame: 20 weeks
measure: Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham
timeFrame: 20 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Susan Redline, M.D., M.P.H.
role: STUDY_DIRECTOR
affiliation: Case Western Reserve University
name: Faramarz Beigi
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: H Lester Kirchner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Carol Rosen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: John Haaga, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Kingman Strohl, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Reena Mehra, M.S., M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University
name: Denise Babineau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Tanya Weinstock, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.