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| ID | Type | Description | Link |
|---|---|---|---|
| 1UL1TR001114-01 | U.S. NIH Grant/Contract | View source |
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The aim of this trial will be to determine an effect-size for the administration of chronic low-dose colchicine in the reduction of serum levels of triglycerides (TG), very-low density lipoproteins (VLDL), and apolipoprotein CIII (apoCIII) in human subjects over a period of 4-6 weeks.
The aim of this proposal will be to show, in a translational fashion, a relationship between colchicine and reduction of factors affecting triglyceride metabolism, especially apoCIII and VLDL levels. We envision colchicine as playing a role in identifying and elucidating a new mechanism for lowering TG levels, which may have a great impact on targeting patients who have not met non-HDL goals according to Adult Treatment Panel III (ATPIII guidelines) or at risk for hypertriglyceridemia-induced pancreatitis [11]. We will accomplish this by conducting a prospective cohort clinical trial of low-dose colchicine in hypertriglyceridemic patients to assess percent (%) reduction of apoCIII, VLDL, and TG. Secondary endpoints will be to observe the effects of colchicine on apoA, apoB, HDL, low-density lipoprotein (LDL), and total cholesterol (TC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental | Patients will be enrolled with either gout/pericarditis or hypertriglyceridemia, have VAP and Apolipoprotein CIII levels at baseline, administer Colchicine for 6 weeks with reassessment of Apolipoprotein CIII and VAP. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in ApoCIII levels | 6 weeks | |
| Reduction of triglycerides and very low density lipoprotein (VLDL) levels | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Apolipoprotein A and Apolipoprotein B via Vertical Auto Profile (VAP) | 6 weeks |
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Inclusion Criteria:
Acute new-onset pericarditis or recurrent pericarditis (≥2 following criteria)
OR
•Acute gouty arthritis (according to the ACR; ≥1 of following criteria:
If N < 10 after 3 weeks of trial initiation, then employ enrollment strategy #2
Enrollment strategy #2:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Schultz, PhD | Scripps Translational Science Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Translational Science Institute | La Jolla | California | 92037 | United States |
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| ID | Term |
|---|---|
| D015228 | Hypertriglyceridemia |
| D006073 | Gout |
| D010493 | Pericarditis |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |