Regulation of Lipoprotein Metabolism in Obese Men

The University of Western Australia

Status and phase

Completed

Phase 3

Conditions

Insulin Resistance

Obesity

Dyslipidemia

Treatments

Drug: Fish oils

Drug: Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00392717

EC-576

Details and patient eligibility

About

Visceral obesity is strongly associated with dyslipidaemia (hypertriglyceridaemia, low HDL-cholesterol and mildly elevated LDL-cholesterol) and insulin resistance, key characteristics of metabolic syndrome (MetS). Recent evidence has clearly established that the risk of CVD is increased in subjects with the MetS. The precise reason for this remains unclear, but appears to be closely related with dyslipidaemia. Effective management of dyslipidaemia is important to reduce the risk of CVD in these subjects.

Hypothesis: Inhibition of hepatic cholesterol synthesis by statins and triglyceride synthesis by fish oils improve lipoprotein metabolism in visceral obese men.

Full description

The study employed a factorial study design, stable isotopy and mathematical modelling to examine the independent and combined effects of decreasing cholesterol substrate availability with atorvastatin and decreasing triglyceride substrate availability with fish oils on lipoprotien kinetics (apoB, apoA, apoC-III and chylomicron remnants) in insulin-resistant men with visceral obesity.

Sex

Male

Ages

20 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Obesity was defined as a waist circumference >100 cm, waist:hip ratio >0.97 and BMI >29 kg/m2.
Subjects were selected for having insulin-resistance, defined as a homostasis model assessment (HOMA) score (21) >5.1 (i.e. one SD above the mean for a reference population of 22 lean, normolipidemic healthy males of similar age).
All subjects had plasma triglyceride >1.2 mmol/L and cholesterol >5.2 mmol/L at screening while consuming ad libitum, weight-maintaining diets

Exclusion criteria

diabetes mellitus, apolipoprotein E2/E2 genotype, macroproteinuria, creatinemia, hypothyrodism, or abnormal liver enzymes.
Subjects did not consume fish oil supplements or drank more than 30g alcohol/day.
None reported a history of CVD, or was taking medication or other agents known to affect lipid metabolism.