Status:
COMPLETED
Regulation of Lipoprotein Metabolism in Obese Men
Lead Sponsor:
The University of Western Australia
Conditions:
Obesity
Dyslipidemia
Eligibility:
MALE
20-70 years
Phase:
PHASE3
Brief Summary
Visceral obesity is strongly associated with dyslipidaemia (hypertriglyceridaemia, low HDL-cholesterol and mildly elevated LDL-cholesterol) and insulin resistance, key characteristics of metabolic syn...
Detailed 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 atorvastati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 1998
Trial Type :
INTERVENTIONAL
End Date :
March 1 2002
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00392717
Start Date
February 1 1998
End Date
March 1 2002
Last Update
October 26 2006
Active Locations (1)
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1
Royal Perth Hospital
Perth, Western Australia, Australia, 6000