Impaired Glucose TolerancePhase 2NCT01385995

Effects of Treatment of Sleep Apnea on Metabolic Syndrome

A Phase 2 study testing Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP) in people with Impaired Glucose Tolerance and Obstructive Sleep Apnea, run by Brigham and Women's Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Impaired Glucose Tolerance, Obstructive Sleep Apnea
What is being tested?: Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: No sites listed yet
Study dates: Jan 2004to Sep 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

About this study

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

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.

Read the 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.

Conditions: Impaired Glucose Tolerance, Obstructive Sleep Apnea
Being tested: Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP), Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)
Medical subject headings: Glucose Intolerance, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)Device
Also called 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)Device
Also called Philips-Respironics Sham CPAP
Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.

Study groups in NCT01385995
Study group	Role	What they receive
Continuous Positive Airway Pressure (CPAP)	Active comparator	Not described Receives: Device: Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)
Sham-Continuous Positive Airway Pressure (CPAP)	Sham comparator	Not described Receives: Device: Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 20 weeks

Secondary outcomes (4)

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)
Measured: 20 weeks
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.
Measured: 20 weeks
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
Measured: 20 weeks
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.
Measured: 20 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2004Sep 2008

First posted30 Jun 2011 (estimated)
Study startJan 2004
Primary completionSep 2008
Study completionSep 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01385995
Sponsor's protocol ID: HL075077
Other IDs: UL1RR024989
Status last verified: Feb 2014
First submitted: 23 Jun 2011
Last updated: 12 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 22547887

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Impaired Glucose Tolerance trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Controlled Trial of Continuous Positive Airway Pressure (CPAP) Therapy on Metabolic Control in Individuals With Impaired Glucose Tolerance and Sleep Apnea
ClinicalTrials.gov ID: NCT01385995
Acronym / sponsor ID: HL075077
Conditions: Impaired Glucose Tolerance, Obstructive Sleep Apnea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Center for Research Resources (NCRR), Beth Israel Deaconess Medical Center, Case Western Reserve University
Study start: Jan 2004
Primary completion: Sep 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 30 Jun 2011 (estimated)
Results: Posted 26 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Continuous Positive Airway Pressure (CPAP)	Active comparator	Device: Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)
Sham-Continuous Positive Airway Pressure (CPAP)	Sham comparator	Device: Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)Also: Philips-Respironics RemStar Pro® CPAPSubjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.	Device	Continuous Positive Airway Pressure (CPAP)
Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)Also: Philips-Respironics Sham CPAPSubjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.	Device	Sham-Continuous Positive Airway Pressure (CPAP)

Primary outcome

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)

4 secondary outcomes

Mean and Standard Deviation of Glucose Indices After Therapeutic CPAP vs. Sham
Time frame: 20 weeks
Mean and Standard Deviation of Insulin Indices After Therapeutic CPAP vs. Sham
Time frame: 20 weeks
Mean and Standard Deviation of Indices of Insulin Resistance With Therapeutic CPAP vs. Sham
Time frame: 20 weeks
Mean and Standard Deviation of Insulin Sensitivity Index (ISI(0,120)) With Therapeutic CPAP vs. Sham
Time frame: 20 Weeks

Results and safety

Results posted to the registry on 26 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Continuous Positive Airway Pressure (CPAP)	25	24
Sham-Continuous Positive Airway Pressure	25	25

Primary outcome: Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT)

Time frame: 20 weeks. Number. Unit: subjects

Measure	Therapeutic CPAP n = 47	Sham CPAP n = 47
Value	7	5

Therapeutic CPAP vs Sham CPAP: Odds Ratio (OR): 1.30 (95% CI 0.52 to 3.24), p = 0.57, Generalized Estimating Equation

Population analysed: All available oral glucose tolerance test data was analyzed for the total sample.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Continuous Positive Airway Pressure (CPAP)	1 of 50 (2%)	12 of 50 (24%)	Not reported
Sham-Continuous Positive Airway Pressure	0 of 50 (0%)	7 of 50 (14%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22547887Weinstock 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susan Redline, M.D., M.P.H. study director

Brigham and Women's Hospital

Faramarz Beigi principal investigator

Case Western Reserve University

H Lester Kirchner, PhD principal investigator

Case Western Reserve University

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Normalization of Impaired Glucose Tolerance (IGT) (time frame: 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01385995, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.