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Effect of Abdominal Obesity on Lipoprotein Metabolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00438061
First Posted: February 21, 2007
Last Update Posted: February 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The University of Western Australia
  Purpose

Abdominal obesity is strongly associated with dyslipidemia, which may account for the associated increased risk of atherosclerosis and coronary disease. Weight reduction is suggested to be a preferred and effective first-line strategy to correct lipid abnormalities, particularly in overweight/obese subjects. This improvement may be related to the effect of reduction in abdominal fat mass on apoB and apoA-I metabolism, but this remains to be fully demonstrated.

Hypothesis: Reduction in abdominal fat mass by weight loss decreases apoB concentration and raises HDL-cholesterol chiefly by increasing LDL-apoB fractional catabolic rate (FCR), as well as decreasing HDL apoA-I, respectively.


Condition Intervention Phase
Obesity Dyslipidemia Insulin Resistance Behavioral: Weight loss by dietary restriction Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Weight Loss on Lipoprotein Metabolism in Abdominal Obesity

Resource links provided by NLM:


Further study details as provided by The University of Western Australia:

Primary Outcome Measures:
  • Primary: Fractional catabolic and production rates of LDL-apoB and HDL-apoA-I (before and after 16 week treatments)

Secondary Outcome Measures:
  • Secondary: Cholesterol; Triglyceride; LDL-cholesterol; Adipocytokines; Genetic polymorphism

Estimated Enrollment: 40
Study Start Date: January 1995
Estimated Study Completion Date: December 1998
Detailed Description:
We examined the mechanism of the effect of weight loss through dieting on LDL and HDL metabolism in abdominally obese men. LDL apoB-100 and HDL apoA-I kinetics were studied using a primed-constant infusion of 1-[13C]-leucine in a controlled, dietary intervention trial of 16 weeks duration in middle-aged, obese men with the metabolic syndrome. Isotopic enrichment in apoB and apoA-I was measured by gas chromatography-mass spectrometry and fractional turnover rates estimated using multi-compartmental modelling.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obesity was defined as a body mass index (BMI) >28kg/m2 and visceral visceral obesity (waist to hip ratio> 1.0 or waist circumference >100 cm)

Exclusion Criteria:

  • Diabetes mellitus,
  • Proteinuria,
  • Hypothyroidism,
  • Abnormal liver enzymes,
  • Major systemic illness,
  • A history of alcohol abuse,
  • A family history of hyperlipidemia or premature coronary artery disease or were taking medication known to affect lipid metabolism.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438061


Locations
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
The University of Western Australia
Investigators
Principal Investigator: Dick C Chan, PhD The University of Western Australia
Study Chair: Gerald F Watts, MD The University of Western Australia
  More Information

ClinicalTrials.gov Identifier: NCT00438061     History of Changes
Other Study ID Numbers: EC-256
First Submitted: February 20, 2007
First Posted: February 21, 2007
Last Update Posted: February 26, 2007
Last Verified: February 2007

Keywords provided by The University of Western Australia:
Lipoprotein metabolism
Cardiovascular disease
Obesity

Additional relevant MeSH terms:
Obesity
Insulin Resistance
Dyslipidemias
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders