ObesityPhase 3NCT00392717
Regulation of Lipoprotein Metabolism in Obese Men
A Phase 3 study testing Atorvastatin and Fish oils in people with Obesity and Dyslipidemia, run by The University of Western Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Dyslipidemia, Insulin Resistance
- What is being tested?
- Atorvastatin and Fish oils
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 1998to Mar 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Atorvastatin and Fish Oils on Lipoprotein Metabolism in Visceral Obesity
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.
Read the 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.
- Conditions
- Obesity, Dyslipidemia, Insulin Resistance
- Being tested
- Atorvastatin, Fish oils
- Keywords
- lipoprotein metabolism, cardiovascular disease, obesity
- Medical subject headings
- Obesity, Dyslipidemias, Insulin Resistance, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Fish oilsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startFeb 1998
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Investigators
- Dick C Chan, PhD, Principal investigator, The University of Western AustraliaGerald F Watts, MBBS PhD, Study chair, The University of Western AustraliaP Hugh H Barrett, PhD, Study director, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392717
- Sponsor's protocol ID
- EC-576
- Status last verified
- Oct 2006
- First submitted
- 25 Oct 2006
- Last updated
- 26 Oct 2006
- Results posted
- No
Publications
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.
PubMed 19116237
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atorvastatin and Fish Oils on Lipoprotein Metabolism in Visceral Obesity
- ClinicalTrials.gov ID
- NCT00392717
- Acronym / sponsor ID
- EC-576
- Conditions
- Obesity, Dyslipidemia, Insulin Resistance
- Keywords
- lipoprotein metabolism, cardiovascular disease, obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Study start
- Feb 1998
- Study completion
- Mar 2002
- First posted
- 26 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin | Drug | – |
| Fish oils | Drug | – |
Primary outcome
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)
5 secondary outcomes
Cholesterol
Triglyceride
LDL-cholesterol
Adipocytokines
Genetic polymorphisms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2006.
- Derived from this study: PubMed 19116237Chan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dick C Chan, PhD principal investigator
The University of Western Australia
Gerald F Watts, MBBS PhD study chair
The University of Western Australia
P Hugh H Barrett, PhD study director
The University of Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin and Fish oils in people with Obesity and Dyslipidemia, run by The University of Western Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional catabolic rate of apoB, apoA, apoC-III and chylomicron remnants (before and after 6 week treatments). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00392717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2006.