NCT00392717

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at below P25 for phase_3 obesity

Timeline
Completed

Started Feb 1998

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

February 1, 1998

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
Last Updated

October 26, 2006

Status Verified

October 1, 2006

First QC Date

October 25, 2006

Last Update Submit

October 25, 2006

Conditions

ObesityDyslipidemiaInsulin Resistance

Keywords

lipoprotein metabolismcardiovascular diseaseobesity

Outcome Measures

Primary Outcomes (2)

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

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

Secondary Outcomes (5)

  • Cholesterol

  • Triglyceride

  • LDL-cholesterol

  • Adipocytokines

  • Genetic polymorphisms

Interventions

AtorvastatinDRUG
Fish oilsDRUG

Eligibility Criteria

Age20 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Related Publications (1)

  • Chan DC, Barrett PH, Ooi EM, Ji J, Chan DT, Watts GF. Very low density lipoprotein metabolism and plasma adiponectin as predictors of high-density lipoprotein apolipoprotein A-I kinetics in obese and nonobese men. J Clin Endocrinol Metab. 2009 Mar;94(3):989-97. doi: 10.1210/jc.2008-1457. Epub 2008 Dec 30.

    PMID: 19116237DERIVED

MeSH Terms

Conditions

ObesityDyslipidemiasInsulin ResistanceCardiovascular Diseases

Interventions

AtorvastatinFish Oils

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsOils

Study Officials

  • Dick C Chan, PhD

    The University of Western Australia

    PRINCIPAL INVESTIGATOR

  • Gerald F Watts, MBBS PhD

    The University of Western Australia

    STUDY CHAIR

  • P Hugh H Barrett, PhD

    The University of Western Australia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2006

First Posted

October 26, 2006

Study Start

February 1, 1998

Study Completion

March 1, 2002

Last Updated

October 26, 2006

Record last verified: 2006-10

Locations

AU(1)