NCT02083510

Apolipoprotein CIII Reduction Via Colchicine

A Translational Study to Understand the Mechanism of Apolipoprotein CIII Reduction Via Colchicine

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Scripps Translational Science Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Hypertriglyceridemia
• Gout
• Pericarditis

Interventions

Type	Name	Description
DRUG	Colchicine

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-03-11
• Last updated: 2014-05-30

Locations

1 site across 1 country: United States