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

Phase 4

• Conditions: Metabolic syndrome; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12609000620224
• Lead Sponsor: Professor Gerald Watts

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified