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Regulation of Lipoprotein Metabolism in Obese Men

Primary Purpose

Obesity, Dyslipidemia, Insulin Resistance

Status

Completed

Phase

Phase 3

Locations

Australia

Study Type

Interventional

Intervention

Atorvastatin

Fish oils

About this trial

This is an interventional treatment trial for Obesity focused on measuring lipoprotein metabolism, cardiovascular disease, obesity

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

Royal Perth Hospital

Outcomes

Primary Outcome Measures

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 Outcome Measures

Cholesterol

Triglyceride

LDL-cholesterol

Adipocytokines

Genetic polymorphisms

Full Information

NCT ID

NCT00392717

First Posted

October 25, 2006

Last Updated

October 25, 2006

Sponsor

The University of Western Australia

1. Study Identification

Unique Protocol Identification Number

NCT00392717

Brief Title

Regulation of Lipoprotein Metabolism in Obese Men

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2006

Overall Recruitment Status

Completed

Study Start Date

February 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

The University of Western Australia

4. Oversight

5. Study Description

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.

Detailed Description

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.

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

Factorial Assignment

Masking

Double

Allocation

Randomized

Enrollment

48 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Type

Drug

Intervention Name(s)

Fish oils

Primary Outcome Measure Information:

Title

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

Title

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

Secondary Outcome Measure Information:

Title

Cholesterol

Title

Triglyceride

Title

LDL-cholesterol

Title

Adipocytokines

Title

Genetic polymorphisms

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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, MBBS PhD

Organizational Affiliation

The University of Western Australia

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

P Hugh H Barrett, PhD

Organizational Affiliation

The University of Western Australia

Official's Role

Study Director

Facility Information:

Facility Name

Royal Perth Hospital

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6000

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

19116237

Citation

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.

Results Reference

derived

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Regulation of Lipoprotein Metabolism in Obese Men

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