ObesityPhase 4NCT00632840
Pharmacological Regulation of Fat Transport in Metabolic Syndrome
A Phase 4 study testing Atorvastatin and fenofibrate in people with Obesity and Lipid Disorders, run by The University of Western Australia.
Trial summary
The purpose of this study is to determine whether atorvastatin and fenofibrate are effective in the treatment of lipid disorders in obese, insulin resistant subjects. Read more about this study
- Who is it for?
- Ages 25 to 70 years, men only
- Conditions the study is for
- Obesity, Lipid Disorders, Hypertriglyceridemia
- What is being tested?
- Atorvastatin and fenofibrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- No sites listed yet
- Study dates
- Jun 2001to Dec 2007
- Phase
- Phase 4
- 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 25 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any three of the followings
- waist circumference >102cm
- triglycerides >1.7 mmol/L
- HDL-cholesterol <1.05 mmol/L
- blood glucose >6.1 mmol/L
- blood pressure >130/85mmHg
Who cannot join
- plasma cholesterol >7mmo/L
- triglycerides >4.5mmo/L
- diabetes mellitus (defined by oral glucose tolerance test)
- CVD
- consumption of >30g alcohol/day
- use of agents affecting lipid metabolism
Show all 10Show fewer
- APOE2/E2 genotype, macroproteinuria
- creatinaemia (>120umol/L)
- hypothyroidism
- abnormal liver and muscle enzymes.
About this study
Official title: Regulation of Lipoprotein Kinetics by Atorvastatin and Fenofibrate With the Metabolic Syndrome
The purpose of this study is to determine whether atorvastatin and fenofibrate are effective in the treatment of lipid disorders in obese, insulin resistant subjects.
Read the detailed description
Insulin resistance is a heterogeneous metabolic disorder of complex etiology. It underpins dyslipoproteinemia, a key feature of the metabolic syndrome (MetS) that independently predicts cardiovascular disease (CVD). Hypertriglyceridemia, the most consistent lipid disorder in subjects with obesity and type 2 diabetes mellitus, is chiefly a consequence of overproduction and delayed clearance of triglyceride-rich lipoproteins (TRLs). Although the precise mechanisms involved are incompletely understood, experimental and clinical evidence suggests that elevated apolipoprotein (apo) C-III may play a crucial role in the dysregulation of TRL metabolism. investigating the effects of these agents on VLDL-apoC-III kinetics. In this study, we aimed to examine the effect of two lipid-regulating agents, atorvastatin and fenofibrate on VLDL-apoC-III transport. We hypothesized that atorvastatin and fenofibrate would have similar effects on apoC-III transport by decreasing the production and increasing the catabolism of VLDL-apoC-III.
- Conditions
- Obesity, Lipid Disorders, Hypertriglyceridemia, Cardiovascular Disease
- Being tested
- Atorvastatin and fenofibrate
- Medical subject headings
- Obesity, Lipid Metabolism Disorders, Hypertriglyceridemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin and fenofibrateDrug
Also called Lipitor, Lofibra
atorvastatin (40mg/day) fenofibrate (200mg/day)
| Study group | Role | What they receive |
|---|---|---|
| P | Placebo comparator | placebo group Receives: Drug: Atorvastatin and fenofibrate |
| Feno | Active comparator | Fenofibrate Receives: Drug: Atorvastatin and fenofibrate |
| ATV | Active comparator | Atorvastatin Receives: Drug: Atorvastatin and fenofibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
VLDL-apoC-III transport rate
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startJun 2001
- Primary completionDec 2002
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart Foundation, Australia
- Investigators
- Dick C Chan, PhD, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632840
- Sponsor's protocol ID
- UWA_DC012008
- Status last verified
- Feb 2008
- First submitted
- 20 Feb 2008
- Last updated
- 11 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Chan DC, Watts GF, Ooi EM, Rye KA, Ji J, Johnson AG, Barrett PH. Regulatory effects of fenofibrate and atorvastatin on lipoprotein A-I and lipoprotein A-I:A-II kinetics in the metabolic syndrome. Diabetes Care. 2009 Nov;32(11):2111-3. doi: 10.2337/dc09-0519. Epub 2009 Aug 3.
PubMed 19651918Chan 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 11 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Lipoprotein Kinetics by Atorvastatin and Fenofibrate With the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00632840
- Acronym / sponsor ID
- UWA_DC012008
- Conditions
- Obesity, Lipid Disorders, Hypertriglyceridemia, Cardiovascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Collaborators
- National Heart Foundation, Australia
- Study start
- Jun 2001
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Mar 2008 (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.
The purpose of this study is to determine whether atorvastatin and fenofibrate are effective in the treatment of lipid disorders in obese, insulin resistant subjects.
Detailed description
Insulin resistance is a heterogeneous metabolic disorder of complex etiology. It underpins dyslipoproteinemia, a key feature of the metabolic syndrome (MetS) that independently predicts cardiovascular disease (CVD). Hypertriglyceridemia, the most consistent lipid disorder in subjects with obesity and type 2 diabetes mellitus, is chiefly a consequence of overproduction and delayed clearance of triglyceride-rich lipoproteins (TRLs). Although the precise mechanisms involved are incompletely understood, experimental and clinical evidence suggests that elevated apolipoprotein (apo) C-III may play a crucial role in the dysregulation of TRL metabolism. investigating the effects of these agents on VLDL-apoC-III kinetics. In this study, we aimed to examine the effect of two lipid-regulating agents, atorvastatin and fenofibrate on VLDL-apoC-III transport. We hypothesized that atorvastatin and fenofibrate would have similar effects on apoC-III transport by decreasing the production and increasing the catabolism of VLDL-apoC-III.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| P | Placebo comparator | Drug: Atorvastatin and fenofibrateplacebo group |
| Feno | Active comparator | Drug: Atorvastatin and fenofibrateFenofibrate |
| ATV | Active comparator | Drug: Atorvastatin and fenofibrateAtorvastatin |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- any three of the followings
- waist circumference >102cm
- triglycerides >1.7 mmol/L
- HDL-cholesterol <1.05 mmol/L
- blood glucose >6.1 mmol/L
Key exclusion criteria (10 listed)
- plasma cholesterol >7mmo/L
- triglycerides >4.5mmo/L
- diabetes mellitus (defined by oral glucose tolerance test)
- CVD
- consumption of >30g alcohol/day
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 and fenofibrateAlso: Lipitor, Lofibraatorvastatin (40mg/day) fenofibrate (200mg/day) | Drug | ATV, Feno, P |
Primary outcome
VLDL-apoC-III transport rate
Time frame: 5 weeks
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 11 Mar 2008.
- Derived from this study: PubMed 19651918Chan DC, Watts GF, Ooi EM, Rye KA, Ji J, Johnson AG, Barrett PH. Regulatory effects of fenofibrate and atorvastatin on lipoprotein A-I and lipoprotein A-I:A-II kinetics in the metabolic syndrome. Diabetes Care. 2009 Nov;32(11):2111-3. doi: 10.2337/dc09-0519. Epub 2009 Aug 3.
- 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin and fenofibrate in people with Obesity and Lipid Disorders, run by The University of Western 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 6 inclusion and 10 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 11 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
VLDL-apoC-III transport rate (time frame: 5 weeks). 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 NCT00632840, which also lists 2 linked publications.
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 11 Mar 2008.