Effect of Abdominal Obesity on Lipoprotein Metabolism
Primary Purpose
Obesity, Dyslipidemia, Insulin Resistance
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Weight loss by dietary restriction
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Lipoprotein metabolism, Cardiovascular disease, Obesity
Eligibility 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.
Sites / Locations
- Royal Perth Hospital
Outcomes
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
Full Information
NCT ID
NCT00438061
First Posted
February 20, 2007
Last Updated
February 23, 2007
Sponsor
The University of Western Australia
1. Study Identification
Unique Protocol Identification Number
NCT00438061
Brief Title
Effect of Abdominal Obesity on Lipoprotein Metabolism
Official Title
Effect of Weight Loss on Lipoprotein Metabolism in Abdominal Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
January 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1998 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Western Australia
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Dyslipidemia, Insulin Resistance
Keywords
Lipoprotein metabolism, Cardiovascular disease, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Weight loss by dietary restriction
Primary Outcome Measure Information:
Title
Primary: Fractional catabolic and production rates of LDL-apoB and HDL-apoA-I (before and after 16 week treatments)
Secondary Outcome Measure Information:
Title
Secondary: Cholesterol; Triglyceride; LDL-cholesterol; Adipocytokines; Genetic polymorphism
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dick C Chan, PhD
Organizational Affiliation
The University of Western Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerald F Watts, MD
Organizational Affiliation
The University of Western Australia
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
12. IPD Sharing Statement
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Effect of Abdominal Obesity on Lipoprotein Metabolism
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