DiabetesNCT01156116
Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk
A study testing CPAP mask in people with Diabetes and Sleep Apnea, run by University of Chicago at 1 site in United States.
Trial summary
Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetes, Sleep Apnea
- What is being tested?
- CPAP mask
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2012
- Phase
- Interventional
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight or obese adults (age ≥45 yrs and BMI ≥25 kg/m2)
- prediabetes and OSA (AHI ≥ 5)
- regular life styles and schedules (no shift work in the past 6 months, no travel across time zones during the past 4 weeks)
- habitual bedtimes of at least 6 hours but not exceeding 9 hours will be eligible.
- not to take any medications during the study period with the exception of antihypertensives and lipid lowering agents
- not on hormone replacement therapy.
- have sedentary activities and no competitive athletes or subjects with high exercise levels.
Who cannot join
- previous or current treatment with supplemental oxygen
- requirement of supplemental oxygen or bi-level positive airway pressure for OSA treatment during titration
- presence of active infection, psychiatric disease or history of other significant illness (e.g., myocardial infarction, congestive heart failure, stroke, arrhythmia, chronic kidney or liver disease0
- clinical depression as evidenced by a score >16 in CES-D scale
- smoking, or routine alcohol use (more than 2 drinks per day), or excessive caffeine intake (>300mg per day)
Trial locations and contacts
1 site in 1 country.
About this study
Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. The objective of this study is to determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA.
Read the detailed description
Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. To determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA. In a randomized, controlled parallel group study, 39 participants were randomized (2:1) to receive either 8-hour nightly CPAP (n=26) or oral placebo (n=13). Sleep was polysomnographically recorded in the laboratory on each night. CPAP adherence was ensured by continuous supervision. Participants continued their daily daytime routine activities outside the laboratory. Glucose metabolism was assessed at baseline and after 2-weeks of assigned treatment using both the oral and intravenous glucose tolerance tests (OGTT and ivGTT, respectively). The primary outcome was the overall glucose response as quantified by the area under the curve for glucose during 2-hour oral glucose tolerance testing.
- Conditions
- Diabetes, Sleep Apnea
- Being tested
- CPAP mask, Placebo
- Keywords
- CPAP, diabetes, sleep apnea
- Medical subject headings
- Diabetes Mellitus, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP maskDevice
Also called continuous positive airway pressure therapy
The subjects who are randomized to CPAP treatment will undergo an overnight CPAP titration in the laboratory, which will be performed manually by a registered technician according to American Academy of Sleep Medicine (AASM) guidelines .Subjects will be admitted in the early evening and will receive positive airway pressure education, hands on demonstration, careful mask fitting and acclimatization prior to titration. The goal during the titration will be to determine the optimal CPAP pressure setting that eliminates obstructive respiratory events, restore oxygen saturations and sleep continuity.
________________________________________
PlaceboDrug
oral placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Continuous positive airway pressure | Active comparator | 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night Receives: Device: CPAP mask |
| Placebo | Placebo comparator | 2 weeks of oral administration of a placebo tablet 30min before bedtime Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2
The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule .
Change = Week 2 - Baseline.
Measured: Baseline and Week 2
Secondary outcomes (3)
Change From Baseline in Insulin Sensitivity (SI) at Week 2
SI is estimated from modeling of the insulin and glucose values during the intravenous glucose tolerance test (ivGTT).
Change = Week 2 - Baseline.
Measured: Baseline and Week 2
Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2
The average systolic blood pressure measured over a 24-hr period was calculated for each patient.
Change = Week 2 - Baseline.
Measured: Baseline and Week 2
Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2
The average diastolic blood pressure over a 24-hr period was calculated for each patient.
Change = Week 2 - Baseline
Measured: Baseline and Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionOct 2012
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 (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esra Tasali, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156116
- Sponsor's protocol ID
- 09-249-A
- Status last verified
- May 2015
- First submitted
- 23 Jun 2010
- Last updated
- 27 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pamidi S, Chapotot F, Wroblewski K, Whitmore H, Polonsky T, Tasali E. Optimal Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea Reduces Daytime Resting Heart Rate in Prediabetes: A Randomized Controlled Study. J Am Heart Assoc. 2020 Oct 20;9(19):e016871. doi: 10.1161/JAHA.120.016871. Epub 2020 Oct 1.
PubMed 32998624Pamidi S, Wroblewski K, Stepien M, Sharif-Sidi K, Kilkus J, Whitmore H, Tasali E. Eight Hours of Nightly Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea Improves Glucose Metabolism in Patients with Prediabetes. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2015 Jul 1;192(1):96-105. doi: 10.1164/rccm.201408-1564OC.
PubMed 25897569
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effective Treatment of Sleep Apnea in Prediabetes to Reduce Cardiometabolic Risk
- ClinicalTrials.gov ID
- NCT01156116
- Acronym / sponsor ID
- 09-249-A
- Conditions
- Diabetes, Sleep Apnea
- Keywords
- CPAP, diabetes, sleep apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Posted 27 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. The objective of this study is to determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA.
Detailed description
Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. To determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA. In a randomized, controlled parallel group study, 39 participants were randomized (2:1) to receive either 8-hour nightly CPAP (n=26) or oral placebo (n=13). Sleep was polysomnographically recorded in the laboratory on each night. CPAP adherence was ensured by continuous supervision. Participants continued their daily daytime routine activities outside the laboratory. Glucose metabolism was assessed at baseline and after 2-weeks of assigned treatment using both the oral and intravenous glucose tolerance tests (OGTT and ivGTT, respectively). The primary outcome was the overall glucose response as quantified by the area under the curve for glucose during 2-hour oral glucose tolerance testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous positive airway pressure | Active comparator | Device: CPAP mask2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night |
| Placebo | Placebo comparator | Drug: Placebo2 weeks of oral administration of a placebo tablet 30min before bedtime |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Overweight or obese adults (age ≥45 yrs and BMI ≥25 kg/m2)
- prediabetes and OSA (AHI ≥ 5)
- regular life styles and schedules (no shift work in the past 6 months, no travel across time zones during the past 4 weeks)
- habitual bedtimes of at least 6 hours but not exceeding 9 hours will be eligible.
- not to take any medications during the study period with the exception of antihypertensives and lipid lowering agents
Key exclusion criteria (5 listed)
- previous or current treatment with supplemental oxygen
- requirement of supplemental oxygen or bi-level positive airway pressure for OSA treatment during titration
- presence of active infection, psychiatric disease or history of other significant illness (e.g., myocardial infarction, congestive heart failure, stroke, arrhythmia, chronic kidney or liver disease0
- clinical depression as evidenced by a score >16 in CES-D scale
- smoking, or routine alcohol use (more than 2 drinks per day), or excessive caffeine intake (>300mg per day)
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 |
|---|---|---|
| CPAP maskAlso: continuous positive airway pressure therapyThe subjects who are randomized to CPAP treatment will undergo an overnight CPAP titration in the laboratory, which will be performed manually by a registered technician according to American Academy of Sleep Medicine (AASM) guidelines .Subjects will be admitted in the early evening and will receive positive airway pressure education, hands on demonstration, careful mask fitting and acclimatization prior to titration. The goal during the titration will be to determine the optimal CPAP pressure setting that eliminates obstructive respiratory events, restore oxygen saturations and sleep continuity. ________________________________________ | Device | Continuous positive airway pressure |
| Placebooral placebo tablet | Drug | Placebo |
Primary outcome
Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2
Time frame: Baseline and Week 2
The area under the glucose time curve, between 0 and 120 minutes of the OGTT, was calculated for each patient using the trapezoidal rule . Change = Week 2 - Baseline.
3 secondary outcomes
Change From Baseline in Insulin Sensitivity (SI) at Week 2
Time frame: Baseline and Week 2
Change From Baseline in 24-hr Systolic Blood Pressure (mmHg) at Week 2
Time frame: Baseline and Week 2
Change From Baseline in 24-hr Diastolic Blood Pressure (mmHg) at Week 2
Time frame: Baseline and Week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32998624Pamidi S, Chapotot F, Wroblewski K, Whitmore H, Polonsky T, Tasali E. Optimal Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea Reduces Daytime Resting Heart Rate in Prediabetes: A Randomized Controlled Study. J Am Heart Assoc. 2020 Oct 20;9(19):e016871. doi: 10.1161/JAHA.120.016871. Epub 2020 Oct 1.
- Derived from this study: PubMed 25897569Pamidi S, Wroblewski K, Stepien M, Sharif-Sidi K, Kilkus J, Whitmore H, Tasali E. Eight Hours of Nightly Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea Improves Glucose Metabolism in Patients with Prediabetes. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2015 Jul 1;192(1):96-105. doi: 10.1164/rccm.201408-1564OC.
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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.
Esra Tasali, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP mask in people with Diabetes and Sleep Apnea, run by University of Chicago at 1 site in United States.
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 7 inclusion and 5 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 May 2015). 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?
Change From Baseline in Area Under the Curve (AUC) Glucose at Week 2 (time frame: Baseline and Week 2). 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 NCT01156116, which also lists 2 linked publications.
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 27 May 2015.