Insulin SensitivityNCT02192684
Obesity, Sleep Apnea, and Insulin Resistance
A study testing Pioglitazone in people with Insulin Sensitivity and Obstructive Sleep Apnea, run by Stanford University.
Trial summary
Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and public health burdens in the United States. That these diseases appear to co-exist and together increase one's risk of cardiovascular disease renders investigation into their shared pathophysiology even more urgent. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Sensitivity, Obstructive Sleep Apnea
- What is being tested?
- Pioglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Mar 2015
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Individuals
- Age 30-70 years old
- BMI- 25-40 kg/m2
- Must meet criteria for obstructive sleep apnea by overnight in-laboratory polysomnography
Who cannot join
- Any significant co-morbidities, such as diabetes, active heart, kidney, liver diseases, or active or history of bladder cancer.
- Must not have previously received treatment for OSA, including CPAP.
- Must not be receiving any medications intended for weight loss, or those known to influence insulin sensitivity.
- Pregnancy/lactation is also an exclusion.
About this study
Official title: Interfacing Adiposity, Sleep Apnea, and Insulin Resistance
Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and public health burdens in the United States. That these diseases appear to co-exist and together increase one's risk of cardiovascular disease renders investigation into their shared pathophysiology even more urgent. Investigators will assess prevalence of insulin resistance, a precursor to diabetes, among overweight patients with OSA. Among those at highest risk of diabetes, investigators will randomize participants to pioglitazone or placebo to see the efficacy of the intervention on improving OSA, insulin resistance, and/or insulin secretion. In a separate intervention, investigators will evaluate the cardiometabolic benefits of continuous positive airway pressure (CPAP) for 12 weeks in patients with OSA. Investigators will also study subjects from the community without known sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea using clinical screening questionnaires.
- Conditions
- Insulin Sensitivity, Obstructive Sleep Apnea
- Being tested
- Pioglitazone, placebo
- Keywords
- obstructive sleep apnea, insulin sensitivity, cardiovascular risk, positive airway pressure therapy
- Medical subject headings
- Insulin Resistance, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called actos
45 mg daily Insulin sensitizing
placeboDrug
Compare with pioglitazone
| Study group | Role | What they receive |
|---|---|---|
| pioglitazone | Active comparator | pioglitazone 45 mg, oral, daily Receives: Drug: Pioglitazone |
| placebo | Placebo comparator | Placebo, one pill daily Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo
To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startSep 2010
- Primary completionJul 2014
- Study completionMar 2015
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 Insulin SensitivityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerald M Reaven, Stanford University
- Investigators
- Gerald M Reaven, M.D., Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192684
- Sponsor's protocol ID
- 5U01HL108647-04
- Status last verified
- Mar 2017
- First submitted
- 7 Jul 2014
- Last updated
- 21 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Liu A, Kim SH, Ariel D, Abbasi F, Lamendola C, Cardell J, Xu S, Patel S, Tomasso V, Mojaddidi H, Grove K, Tsao PS, Kushida CA, Reaven GM. Does enhanced insulin sensitivity improve sleep measures in patients with obstructive sleep apnea: a randomized, placebo-controlled pilot study. Sleep Med. 2016 Jun;22:57-60. doi: 10.1016/j.sleep.2016.06.005. Epub 2016 Jun 21.
PubMed 27544837
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interfacing Adiposity, Sleep Apnea, and Insulin Resistance
- ClinicalTrials.gov ID
- NCT02192684
- Acronym / sponsor ID
- 5U01HL108647-04
- Conditions
- Insulin Sensitivity, Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, insulin sensitivity, cardiovascular risk, positive airway pressure therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Posted 21 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and public health burdens in the United States. That these diseases appear to co-exist and together increase one's risk of cardiovascular disease renders investigation into their shared pathophysiology even more urgent. Investigators will assess prevalence of insulin resistance, a precursor to diabetes, among overweight patients with OSA. Among those at highest risk of diabetes, investigators will randomize participants to pioglitazone or placebo to see the efficacy of the intervention on improving OSA, insulin resistance, and/or insulin secretion. In a separate intervention, investigators will evaluate the cardiometabolic benefits of continuous positive airway pressure (CPAP) for 12 weeks in patients with OSA. Investigators will also study subjects from the community without known sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea using clinical screening questionnaires.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pioglitazone | Active comparator | Drug: Pioglitazonepioglitazone 45 mg, oral, daily |
| placebo | Placebo comparator | Drug: placeboPlacebo, one pill daily |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy Individuals
- Age 30-70 years old
- BMI- 25-40 kg/m2
- Must meet criteria for obstructive sleep apnea by overnight in-laboratory polysomnography
Key exclusion criteria (4 listed)
- Any significant co-morbidities, such as diabetes, active heart, kidney, liver diseases, or active or history of bladder cancer.
- Must not have previously received treatment for OSA, including CPAP.
- Must not be receiving any medications intended for weight loss, or those known to influence insulin sensitivity.
- Pregnancy/lactation is also an exclusion.
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 |
|---|---|---|
| PioglitazoneAlso: actos45 mg daily Insulin sensitizing | Drug | pioglitazone |
| placeboCompare with pioglitazone | Drug | placebo |
Primary outcome
Change in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo
Time frame: 8 weeks
To evaluate the effects of pioglitazone versus placebo on AHI in patients with OSA.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27544837Liu A, Kim SH, Ariel D, Abbasi F, Lamendola C, Cardell J, Xu S, Patel S, Tomasso V, Mojaddidi H, Grove K, Tsao PS, Kushida CA, Reaven GM. Does enhanced insulin sensitivity improve sleep measures in patients with obstructive sleep apnea: a randomized, placebo-controlled pilot study. Sleep Med. 2016 Jun;22:57-60. doi: 10.1016/j.sleep.2016.06.005. Epub 2016 Jun 21.
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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.
Gerald M Reaven, M.D. principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Pioglitazone in people with Insulin Sensitivity and Obstructive Sleep Apnea, run by Stanford University.
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 4 inclusion and 4 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 21 Apr 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2017). 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 in Apnea-hypopnea Index (AHI) Outcome Measure in Response to Pioglitazone or Placebo (time frame: 8 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 NCT02192684, 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 21 Apr 2017.