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Completed

NCT Number: NCT00392717

Regulation of Lipoprotein Metabolism in Obese Men

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Dyslipidemia Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

atorvastatin

Drug

Fish oils

Drug

Primary outcomes

  1. Fractional catabolic rate of apoB, apoA, apoC-III and chylomicron remnants (before and after 6 week treatments)

  2. Production rate of apoB, apoA, apoC-III and chylomicron remnants (before and after 6 week treatments)

Secondary outcomes

  1. Cholesterol

  2. Triglyceride

  3. LDL-cholesterol

  4. Adipocytokines

  5. Genetic polymorphisms

Sponsors and collaborators

Lead sponsor

The University of Western Australia

Other

Registry information

Official study title

Effect of Atorvastatin and Fish Oils on Lipoprotein Metabolism in Visceral Obesity

Important dates

Study start
1998
Study completion
2002
First posted
Oct 26, 2006
Registry last updated
Oct 26, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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