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| Name | Class |
|---|---|
| Center for Medicinal Cannabis Research | OTHER |
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This study will examine the effects THC has on Glucose Metabolism and Endothelial Functioning in participants with Type 2 Diabetes. The participants will complete blood tests and tests to measure energy expenditure, CVD risks, and glucose metabolism. These tests will be performed prior to start of treatment and again after 2-weeks of treatment with the THC or placebo.
A single-center, double-blind, placebo-controlled, cross-over study designed to evaluate the effects of THC on glucose metabolism and endothelial functioning in individuals with type 2 diabetes. To accomplish the specific AIMS proposed, a single clinical trial will be conducted in which a maximum of 30 subjects with T2D, who are otherwise healthy, will be treated with THC and matching placebo in a cross-over study design. Each treatment period will be 2 weeks in duration with metabolic and endothelial assessments done post-therapy. Subjects will be randomized on a 1:1 basis to either receive either THC or placebo for the first 2 weeks of therapy. Then following a 4-week washout, they will receive the opposite investigational product for the second 2 weeks of therapy. Subjects will remain on their standard treatment for T2D throughout the entire course of the study. There will be a total of 10 study visits and subjects will be enrolled for approximately 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active THC | Active Comparator | Daily, inhaled, flexible dose of cannabis product with THC. |
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| Placebo Cannabis | Placebo Comparator | Daily, inhaled, flexible dose of cannabis product without THC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THC | Drug | 2-Week, once daily, flexible dose, inhaled THC |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Glucose Disposal Rate | The change in glucose uptake from placebo treatment to THC treatment as measure by the hyperinsulinemic/euglycemic clamp. | 6 weeks |
| Change in Vascular Endothelial Function | The change in vascular endothelial function from placebo treatment to THC treatment as measured by reactive hyperemia-peripheral arterial tonometry (reactive hyperemia index). | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Todd May, MS | Contact | 858-246-2169 | tmay@health.ucsd.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Altman Clinical & Translational Research Institute | Recruiting | La Jolla | California | 92037 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| C587251 | nabiximols |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Single-Center, double-blind, placebo-controlled, crossover study.
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Double-blind
| Placebo | Drug | 2-Week, once daily, flexible dose, inhaled placebo |
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| D004700 | Endocrine System Diseases |