An Early Phase 1 interventional study of Colchicine in Hypertriglyceridemia, Gout and Pericarditis, sponsored by Scripps Translational Science Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-30.
Sponsored by Scripps Translational Science Institute · Early Phase 1, Interventional, and Basic science
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).
58 studies on the registry are indexed under Pericarditis; 23 are open to participants now.
This study's enrollment of 5 is below the median of 55 across 28 interventional studies indexed under Pericarditis.
Browse Pericarditis studies →Scripps Translational Science Institute is the lead sponsor of 52 studies on the registry; 13 are open to participants now.
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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:
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.
Drug: Colchicine
Also known as: Colcrys
Reduction in ApoCIII levels
Time frame: 6 weeks
Reduction of triglycerides and very low density lipoprotein (VLDL) levels
Time frame: 6 weeks
Measurement of Apolipoprotein A and Apolipoprotein B via Vertical Auto Profile (VAP)
Time frame: 6 weeks
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Scripps Translational Science Institute