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This study will investigate the molecular mechanisms of atypical-antipsychotic induced insulin resistance. This will be accomplished by administering olanzapine or placebo to healthy subjects for 7 days and analyzing genetic and protein changes in peripheral tissues known to play an important role in insulin resistance pathophysiology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| olanzapine | Experimental | Atypical antipsychotic |
|
| placebo | Placebo Comparator | Placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olanzapine | Drug | atypical antipsychotic |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in DNA methylation | Change in peripheral tissue candidate gene methylation will be measured in the olanzapine intervention group compared to placebo | Baseline (day 1) to endpoint of intervention (day 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in protein levels | Change in peripheral tissue candidate protein levels will be measured in the olanzapine intervention group compared to placebo | Baseline (day 1) to endpoint of intervention (day 7) |
| Change in protein activity |
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We will include persons that meet the following criteria:
The following persons will be excluded:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University Clinical Research Center | Detroit | Michigan | 48202 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 28, 2018 | Feb 6, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| placebo | Drug | placebo control |
|
Change in peripheral tissue candidate protein phosphorylation will be measured in the olanzapine intervention group compared to placebo
| Baseline (day 1) to endpoint of intervention (day 7) |
| D006571 | Heterocyclic Compounds |