Sleep ApneaNCT04234217
Mechanisms of Prediabetic States in Sleep Apnea
A study testing Continuous positive airway pressure and Niacin in people with Sleep Apnea and Pre-diabetes, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to better understand how sleep apnea contributes to the development of diabetes. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Sleep Apnea, Pre-diabetes
- What is being tested?
- Continuous positive airway pressure and Niacin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2019to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Overweight or obese
- Prediabetic
- Sleep apnea
Who cannot join
- Diabetic
- Severe hypertension
- Taking medications that can confound assessments
- Any history of known bleeding disorders
- Any underlying disease likely to limit life span or increase risk of intervention
- Currently pregnant, trying to get pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to better understand how sleep apnea contributes to the development of diabetes.
Read the detailed description
Substantial evidence indicates that obstructive sleep apnea (OSA) is associated with impaired glucose metabolism, however, metabolic mechanisms underlying this association remain unclear. This mechanistic study will determine systemic and cellular metabolic pathways that contribute to impaired glucose metabolism in obstructive sleep apnea (OSA). Understanding of how obstructive sleep apnea (OSA) affects glucose metabolism may help identify novel targets for risk prediction and/or treatment of metabolic impairments beyond continuous positive airway pressure (CPAP). Obstructive sleep apnea (OSA) patients with prediabetes will be studied under three in-laboratory conditions in a randomized cross-over design: untreated condition (obstructive sleep apnea), treated condition (continuous positive airway pressure), untreated but pharmacologically suppressed lipolysis condition (Niacin). The investigator will perform whole body and cellular assessments under each study condition.
- Conditions
- Sleep Apnea, Pre-diabetes
- Being tested
- Continuous positive airway pressure, Niacin
- Keywords
- Sleep
- Medical subject headings
- Sleep Apnea Syndromes, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive airway pressureDevice
Also called CPAP
Continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA)
NiacinOther
Also called Suppression of lipolysis by niacin infusion
Suppression of lipolysis by niacin infusion
| Study group | Role | What they receive |
|---|---|---|
| Untreated | No intervention | Untreated condition (obstructive sleep apnea) |
| Continuous positive airway pressure (CPAP) treatment | Active comparator | Continuous positive airway pressure (CPAP) treatment Receives: Device: Continuous positive airway pressure |
| Niacin | Active comparator | Untreated, pharmacological suppression of lipolysis by Niacin Receives: Other: Niacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity
Insulin sensitivity is calculated from a model fitted to blood glucose using insulin and C-peptide values measured during a glucose tolerance test
Measured: Untreated, within 4 months of screening
Insulin Sensitivity
Insulin sensitivity is calculated from a model fitted to blood glucose using insulin and C-peptide values measured during a glucose tolerance test
Measured: CPAP, within 4 months of screening
Insulin Sensitivity
Insulin sensitivity is calculated from a model fitted to blood glucose using insulin and C-peptide values measured during a glucose tolerance test
Measured: Niacin, within 4 months of screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start26 Nov 2019
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI), AdventHealth
- Responsible party
- Sponsor
- Investigators
- Esra Tasali, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234217
- Sponsor's protocol ID
- IRB19-0593
- Other IDs
- R01HL146127
- Status last verified
- Oct 2026
- First submitted
- 18 Dec 2019
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Prediabetic States in Sleep Apnea
- ClinicalTrials.gov ID
- NCT04234217
- Acronym / sponsor ID
- IRB19-0593
- Conditions
- Sleep Apnea, Pre-diabetes
- Keywords
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI), AdventHealth
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand how sleep apnea contributes to the development of diabetes.
Detailed description
Substantial evidence indicates that obstructive sleep apnea (OSA) is associated with impaired glucose metabolism, however, metabolic mechanisms underlying this association remain unclear. This mechanistic study will determine systemic and cellular metabolic pathways that contribute to impaired glucose metabolism in obstructive sleep apnea (OSA). Understanding of how obstructive sleep apnea (OSA) affects glucose metabolism may help identify novel targets for risk prediction and/or treatment of metabolic impairments beyond continuous positive airway pressure (CPAP). Obstructive sleep apnea (OSA) patients with prediabetes will be studied under three in-laboratory conditions in a randomized cross-over design: untreated condition (obstructive sleep apnea), treated condition (continuous positive airway pressure), untreated but pharmacologically suppressed lipolysis condition (Niacin). The investigator will perform whole body and cellular assessments under each study condition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Untreated | No intervention | –Untreated condition (obstructive sleep apnea) |
| Continuous positive airway pressure (CPAP) treatment | Active comparator | Device: Continuous positive airway pressureContinuous positive airway pressure (CPAP) treatment |
| Niacin | Active comparator | Other: NiacinUntreated, pharmacological suppression of lipolysis by Niacin |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Overweight or obese
- Prediabetic
- Sleep apnea
Key exclusion criteria (6 listed)
- Diabetic
- Severe hypertension
- Taking medications that can confound assessments
- Any history of known bleeding disorders
- Any underlying disease likely to limit life span or increase risk of intervention
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 pressureAlso: CPAPContinuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA) | Device | Continuous positive airway pressure (CPAP) treatment |
| NiacinAlso: Suppression of lipolysis by niacin infusionSuppression of lipolysis by niacin infusion | Other | Niacin |
Primary outcome
Insulin Sensitivity
Time frame: Untreated, within 4 months of screening
Insulin sensitivity is calculated from a model fitted to blood glucose using insulin and C-peptide values measured during a glucose tolerance test
Insulin Sensitivity
Time frame: CPAP, within 4 months of screening
Insulin sensitivity is calculated from a model fitted to blood glucose using insulin and C-peptide values measured during a glucose tolerance test
Insulin Sensitivity
Time frame: Niacin, within 4 months of screening
Insulin sensitivity is calculated from a model fitted to blood glucose using insulin and C-peptide values measured during a glucose tolerance test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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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 Continuous positive airway pressure and Niacin in people with Sleep Apnea and Pre-diabetes, 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 3 inclusion and 6 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 2 Nov 2026. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Insulin Sensitivity (time frame: Untreated, within 4 months of screening). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.