Not Yet RecruitingPhase 3Phase 4ACTRN12611000252910

Nicotinic Acid and Lipoprotein (a): The Effect of Extended Release Nicotinic Acid on Plasma Lipoprotein (a), its Isoforms and apo(a) Fragments

Effect Of Extended Release Nicotinic Acid On Plasma Lipoprotein (a), Its Isoforms And Apo(a) Fragments.


Sponsor

A/Prof. K.Kostner

Enrollment

30 participants

Start Date

Apr 1, 2011

Study Type

Interventional

Conditions

Summary

Lipoprotein(a) [Lp(a)] is one of the most atherogenic lipoproteins and consists of a glycoprotein called apo(a) which is covalently linked to an LDL particle. Lp(a) is mostly synthesized in the liver and metabolized both via the kidney and liver. A size polymorphism of apo(a) (high and low molecular weight isoforms) exists that negatively correlates with plasma Lp(a) levels. We could previously show that fragments of apo(a) are secreted into the urine and the daily secretion rate correlates with plasma Lp(a) concentrations. Nicotinic acid (NA) and extended release nicotinic acid (ERN) are currently the only lipid lowering drugs that consistently reduce plasma Lp(a) by up to 30%. Since the mechanism by which ERN lowers Lp(a) is not entirely clear we aim to investigate this mechanism in vivo and in vitro.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Inclusion Criteria2

  • Approximately 30 participants will be recruited for this study.
  • As per the protocol all participants will have elevated Lipoprotein (a), already be taking lipid lowering medication, and be either male or female between 18 and 75 years of age. It is expected that the ratio of recruitment will be unbalanced (male (60%) to female (40%) purely due to the incidence of disease in the community.

Exclusion Criteria1

  • Children are excluded for legal reasons and pregnant women are excluded due to safety considerations to the unborn.

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Interventions

Extended release niacin dose: 2g once daily duration of administration: 8 weeks mode of administration: oral capsule

Extended release niacin dose: 2g once daily duration of administration: 8 weeks mode of administration: oral capsule


Locations(1)

Australia

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