NCT00438061

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3 obesity

Timeline
Completed

Started Jan 1995

Longer than P75 for phase_3 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1995

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1998

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2007

Completed
Last Updated

February 26, 2007

Status Verified

February 1, 2007

First QC Date

February 20, 2007

Last Update Submit

February 23, 2007

Conditions

ObesityDyslipidemiaInsulin Resistance

Keywords

Lipoprotein metabolismCardiovascular diseaseObesity

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Weight loss by dietary restrictionBEHAVIORAL

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

MeSH Terms

Conditions

ObesityDyslipidemiasInsulin ResistanceCardiovascular Diseases

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLipid Metabolism DisordersMetabolic DiseasesHyperinsulinismGlucose Metabolism Disorders

Study Officials

  • Dick C Chan, PhD

    The University of Western Australia

    PRINCIPAL INVESTIGATOR

  • Gerald F Watts, MD

    The University of Western Australia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 21, 2007

Study Start

January 1, 1995

Study Completion

December 1, 1998

Last Updated

February 26, 2007

Record last verified: 2007-02

Locations

AU(1)