Effects of fenofibrate and fish oil on gene expression and metabolic changes in obese subjects

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Body Mass Index > 27 kg/mw
or waist circumference > 88 cm (women) or >102 cm (men)

Exclusion Criteria

- BMI < 27 kg/m2 and waistcircumference <88 cm (women) or <102 cm (men)
- Use of PPARa agonists and / or n-3 / n-6 fatty acid supplements
- Serum cholesterol > 8 mmol/l
- Use of medication that can interact with fenofibrate (study medication), including: HMGCoA reductase inhibitors (statins, eg. lovastatin, pravastatin, simvastatin), anticoagulants (eg. acenocoumarol, phenindione, warfarin)
- Hypersensitivity to (feno)fibrate products
- Active cardiovascular disease like congestive heart failure or recent (<6 months) event (acute myocardial infarction, CVA)
- Pre-existing gallbladder disease
- Diabetes mellitus and anti-diabetic medication (e.g. PPARγ agonists)
- Familial hypercholesterolemia
- Severe medical conditions that might interfere with the study such as epilepsy, asthma, COPD, inflammatory bowel diseases and rheumatoid arthritis.
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Impairment of renal function, as evidenced by increased serum creatinine >150 mmol/L
- Hepatic diseases as manifested by ALT, AST, GGT, total bilirubin or ALP > 2 times the upper limit of normal
- Abuse of drugs and/or alcohol
- Pregnant or breast-feeding women
- Participation in another biomedical study within 1 month prior to the start of this study
- Having donated blood (as blood donor) within 1 month prior to start of this study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Expression of PPARa related genes, markers of insulin resistance, serum lipid<br /><br>and lipoprotein profile and markers of inflammation. </p><br>

Secondary Outcome Measures