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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pioglitazone | Active Comparator | pioglitazone 45 mg, oral, daily |
|
| placebo | Placebo Comparator | Placebo, one pill daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | 45 mg daily Insulin sensitizing |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald M Reaven, M.D. | Stanford University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27544837 | Derived | 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. |
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Recruitment Dates: July 10 2010 - March 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone | pioglitazone 45 mg, oral, daily Pioglitazone: 45 mg daily Insulin sensitizing |
| FG001 | Placebo | Placebo, one pill daily placebo: Compare with pioglitazone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone | pioglitazone 45 mg, oral, daily Pioglitazone: 45 mg daily Insulin sensitizing |
| BG001 | Placebo | Placebo, one pill daily placebo: Compare with pioglitazone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | AHI events/hour | 8 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pioglitazone | pioglitazone 45 mg, oral, daily Pioglitazone: 45 mg daily Insulin sensitizing |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| weight gain | Product Issues | Other | Systematic Assessment |
Unrecognized adverse effect of pioglitazone could have obviated a beneficial effect of enhanced insulin sensitivity on OSA related sleep measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gerald Reaven | Stanford Universtiy | 650-724-3416 | greaven@stanford.edu |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| placebo | Drug | Compare with pioglitazone |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Changes in sleep measure | apnea-hypopnea index (AHI) events per hour | Mean | Standard Deviation | Apnea-hypopnea index (AHI) events/hour |
|
| Insulin Sensitivity | Steady-state plasma glucose (mmol/L) | Mean | Standard Deviation | mmol/L |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | Placebo | Placebo, one pill daily placebo: Compare with pioglitazone | 0 | 15 | 0 | 15 |
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| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |