Apolipoprotein CIII Reduction Via Colchicine

May 28, 2014 updated by: Peter G. Schultz, PhD, Scripps Translational Science Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Scripps Translational Science Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute new-onset pericarditis or recurrent pericarditis (≥2 following criteria)

    • Sharp and pleuritic chest pain improved or relieved by sitting up and leaning forward
    • A pericardial friction rub
    • Electrocardiogram (EKG) findings of diffuse ST-segment elevations or PR depression
    • New or worsening pericardial effusion visualized on echocardiogram.

OR

•Acute gouty arthritis (according to the ACR; ≥1 of following criteria:

  • Joint fluid containing urate crystals
  • Tophus proved to contain urate crystals by chemical means
  • Polarized light microscopy
  • Presence of six of the following in the absence of crystal identification:
  • >1 attack of acute arthritis
  • Maximum inflammation developed in 1 day
  • Monoarthritis attack
  • Redness observed over joints
  • 1st metatarsal joint painful or swollen
  • Unilateral 1st metatarsal joint attack
  • Unilateral tarsal joint attack
  • Tophus (suspected)
  • Hyperuricemia
  • Asymmetric swelling within a joint visible on physical examination or radiography
  • Subcortical cysts without erosions visible on radiography
  • Monosodium urate monohydrate microcrystals in joint fluid during attack
  • Joint fluid culture negative for organisms during attack.

If N < 10 after 3 weeks of trial initiation, then employ enrollment strategy #2

Enrollment strategy #2:

  • History of hypertriglyceridemia (TG ≥ 150 mg/dL) AND
  • Age ≥ 18 years old
  • Capable of providing informed consent
  • Capable of taking Colchicine 0.6-1.2 mg/day orally for 6 weeks
  • Capable of providing a blood sample

Exclusion Criteria:

  • Colchicine use < 8 weeks from baseline VAP panel
  • Pregnant or female of child bearing age
  • On corticosteroid therapy or corticosteroid use < 4 weeks from baseline VAP panel
  • History of statin myopathy or hepatotoxicity
  • History of colchicine intolerance or hypersensitivity
  • Severe end-stage renal disease (eGFR ≤ 20 mL/min/1.73 m2) or requiring dialysis
  • Hepatic Impairment (Child-Pugh class B or C)
  • Myopericarditis (If TnI is elevated on presentation of acute pericarditis)
  • Inflammatory Bowel Disease
  • Tuberculous, neoplastic, or purulent pericarditis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colchicine
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
Other Names:
  • Colcrys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in ApoCIII levels
Time Frame: 6 weeks
6 weeks
Reduction of triglycerides and very low density lipoprotein (VLDL) levels
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of Apolipoprotein A and Apolipoprotein B via Vertical Auto Profile (VAP)
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Translational Science Institute

Investigators

  • Principal Investigator: Peter Schultz, PhD, Scripps Translational Science Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Estimate)

May 30, 2014

Last Update Submitted That Met QC Criteria

May 28, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-6293
  • 1UL1TR001114-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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