The effect of pioglitazone and fish oils on the regulation of fat transport in subjects with the metabolic syndrome

The effect of pioglitazone and fish oils on the therapeutic regulation of lipid transport and hepatic steatosis in the metabolic syndrome

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000620224

Acronym

PIFO

Enrollment

100

Registered

2009-07-27

Start date

2009-08-24

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

The aim of this study is to examine the independent and combined effects of Pioglitazone and Omacor (fish oil) on VLDL transport in metabolic syndrome subjects with non-alcoholic fatty liver disease (NAFLD). NAFLD, which afflicts 20-30% of our population, increases the risk of cardiovascular disease (CVD) and is related to a higher prevalence of insulin resistance, obesity and dyslipidaemia, key characteristics of the metabolic syndrome. Eligible participants will be randomised to one of 4 groups: Pioglitazone alone, Omacor alone, combined Pioglitazone and Omacor, or usual care, that is, no additional treatment or placebo.

Interventions

4 parellel groups. Pioglitazone and Fish oils (Omacor) alone will be compared with a no treatment group and a combined Pioglitazone and Fish oils (Omacor) group. Group 1. Pioglitazone alone 45mg oral tablets daily for a total of 12 weeks Group 2. Fish oils (Omacor) alone 4 1000mg oral capsules daily for a total of 12 weeks Group 3. Combined Pioglitazone 45mg oral tablets daily and Fish oils (Omacor) 4 1000mg oral capsules daily for a total of 12 weeks Group 4. No treatment group

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Non-smoking men aged 18-75 years and post menopausal women aged =75 years will be recruited. In this study we will define the metabolic syndrome on a composite of published criteria: waist circumference >94cm for men and >80cm for women, triglycerides >1.7mmol/L and/or High Density Lipoprotein (HDL)-cholesterol <1.0mmol/L, and Homeostais assessment (HOMA) score >2.5 (>75th percentile of a reference range). To define hepatic steatosis, we will select only metatbolic syndrome subjects with Alanine transaminase (ALT) levels >20U/L.

Exclusion criteria

Subjects with diabetes mellitus (fasting plasma glucose >7.0mmol/L), genetic hyperlipidaemia (e.g. Familial Hypercholesterolaemia), hypothyroidism, cholelithiasis; alcohol excess (>20g/day); proteinuria, creatinaemia (>130umol/L), hepatic dysfunction (Aspartate transaminase (AST) or ALT > 3x upper limit of normal (ULN); muscle disorders or creatinine kinase (>3xULN); major systemic illness or use of steroids or other agents that may influence lipid metabolism; cardiovascular event within the last six months, New York Heart Association (NYHA) class III/IV heart failure; anaemia, osteoporosis and pregnancy: patients on hypocaloric diets;. These exclusions have been defined to limit factors that may influence lipoprotein metabolism and introduce error in testing the hypothesis.

Outcome results