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.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000252910

Enrollment

Registered

2011-03-08

Start date

2011-04-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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 criteria

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

Outcome results