Perhexiline effects on inflammatory activation and insulin sensitivity in diabetics or pre-diabetics with heart disease

Mechanism of action of perhexiline: expression of thioredoxin-interacting protein and insulin sensitivity in pre-diabetics or diabetics with cardiac disease

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000497505

Acronym

nil

Enrollment

Registered

2015-05-19

Start date

2014-04-07

Completion date

2015-12-31

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

Perhexiline is medication known to improve the efficiency of energy used by the heart. It works by reducing fatty acid and thereby improving glucose utilisation by the heart. The hypothesis of the current study is that perhexiline administration reduces pro-inflammatory markers, and improves insulin sensitivity. Analysis will be performed before and after perhexiline therapy in the diabetic patients, and further analysis will be performed to evaluate the extent of changes in the presence or absence of a type of commonly used heart medication in the diabetics (ACE-inhibitors).

Interventions

Perhexiline maleate oral tablet Dose: 600mg all at once on day 1, then 100mg twice daily from day 2 onwards for 14 days or dose adjusted depending on plasma drug concentration performed on day 2. Plasma drug concentration is also to be repeated on day 14.

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 No maximum

Healthy volunteers

Inclusion criteria

1. Diabetes or pre-diabetes 2. Chronic cardiac disease to be treated with perhexiline, any of the following: (a) myocardial ischaaemia (b) refractory angina (c) systolic heart failure (d) severe symptomatic aortic stenosis (e) hypertrophic cardiomyopathy

Exclusion criteria

1. Less than 18 years old 2. Pregnancy, or women of childbearing age who are not using effective contraception 3. Concurrent treatment with any P2Y12 antagonist or perhexiline.

Outcome results