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NCT Number: NCT01385995

Effects of Treatment of Sleep Apnea on Metabolic Syndrome

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.

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Key information

Conditions

Impaired Glucose Tolerance Apnea Dyssomnias Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)

Device

Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.

Other names: Philips-Respironics RemStar Pro® CPAP

Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)

Device

Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.

Other names: Philips-Respironics Sham CPAP

Primary outcomes

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

    Time frame: 20 weeks

    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 outcomes

  1. Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham

    Time frame: 20 weeks

    Reported values include: fasting glucose (mg/dL), 2 hour Oral Glucose Tolerance Test (OGTT) (mg/dL)

  2. Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham

    Time frame: 20 weeks

    The data for fasting and 2 hour Insulin (iIU/dL) are presented according to therapeutic CPAP vs. Sham CPAP.

  3. Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham

    Time frame: 20 weeks

    Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) with therapeutic CPAP vs. Sham CPAP

  4. Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham

    Time frame: 20 Weeks

    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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Case Western Reserve University
  • National Center for Research Resources (NCRR)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jun 30, 2011
Registry last updated
Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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