Effects of Treatment of Sleep Apnea on Metabolic Syndrome

Obstructive Sleep Apnea Clinical Trial

Official title:

A Controlled Trial of Continuous Positive Airway Pressure (CPAP) Therapy on Metabolic Control in Individuals With Impaired Glucose Tolerance and Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385995
• Other study ID #: HL075077
• Secondary ID: UL1RR024989
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2011
• Last updated: February 10, 2014
• Start date: January 2004
• Est. completion date: September 2008

Study information

• Verified date: February 2014
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Glucose Intolerance
• Impaired Glucose Tolerance
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Beth Israel Deaconess Medical Center, Case Western Reserve University, National Center for Research Resources (NCRR), National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	20 weeks	No
Secondary	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)	20 weeks	No
Secondary	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.	20 weeks	No
Secondary	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	20 weeks	No
Secondary	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.	20 Weeks	No