Hypertriglyceridemia With the Metabolic SyndromeNCT00422396
Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis
A study testing Fenofibrate (drug) in people with Hypertriglyceridemia With the Metabolic Syndrome, run by University of Michigan at 1 site in United States.
Trial summary
This is a randomized placebo controlled clinical trial designed to investigate the effects of micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia With the Metabolic Syndrome
- What is being tested?
- Fenofibrate (drug)
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Apr 2002
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- males and postmenopausal females 18 years of age with fasting triglycerides greater than or equal to 1.7 mmol/L and <6.9 mmol/L
- two or more of the following Adult Treatment Panel III (1) criteria of the metabolic syndrome: abdominal obesity (waist circumference >89 cm in females and >102 cm in males); low high-density lipoprotein cholesterol (HDL-C) (<1.3 mmol/L in women and <1.0 mmol/L in men); hypertension (systolic blood pressure >130 or diastolic blood pressure >85 mm Hg) or current drug therapy for hypertension; and impaired fasting glucose (between 6.1 mmol/L and 7.0 mmol/L).
Who cannot join
- included types 1 or 2 diabetes
- Body mass index >40 kg/m2
- Use of lipid-lowering therapies
- Oral hypoglycemic therapies
- Insulin
- Aspirin >81 mg daily
Show all 10Show fewer
- Regular use of non-steroidal anti-inflammatory agents or cyclooxygenase-2 inhibitors, corticosteroids (oral and inhaled), anti-oxidants (including multivitamins), herbal or fiber supplements recent changes in type or formulation of hormone replacement therapy (in the last 6 months)
- Alcohol intake >3 drinks per day
- Untreated hypothyroidism or recent change (within 2 months) of thyroid replacement therapy
- Cigarette smoking (current or within the last 6 months)
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University preventive Cardiology Center
Chicago, Illinois, 60611
About this study
This is a randomized placebo controlled clinical trial designed to investigate the effects of micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other characteristics of the metabolic syndrome.
Read the detailed description
The aim of this study was to determine the effects of micronized fenofibrate (160 mg/daily) on:
- Fasting and postprandial lipids and lipoproteins after a standarized test meal.
- Fasting and postprandial oxidized fatty acids and oxidized low density lipoprotein after a standarized test meal.
- Fasting and postprandial inflammatory mediators after a standarized test meal.
- Fasting and postprandial lipopolysaccharide-stimulated cytokine production after a standarized test meal.
- Fasting and postprandial markers of hemostasis, fibrinolysis and blood viscosity after a standarized test meal.
- Being tested
- Fenofibrate (drug)
- Keywords
- Hypertrigliceridemia, Metabolic syndrome, Obesity, Fenofibrate, Lipoproteins, Cytokines
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenofibrate (drug)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
1. lipids and lipoproteins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startJan 2001
- Primary completionApr 2002
- Study completionApr 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertriglyceridemia With the Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Robert S Rosenson, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422396
- Sponsor's protocol ID
- 877-017
- Status last verified
- Feb 2017
- First submitted
- 12 Jan 2007
- Last updated
- 10 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators and Thrombosis
- ClinicalTrials.gov ID
- NCT00422396
- Acronym / sponsor ID
- 877-017
- Keywords
- Hypertrigliceridemia, Metabolic syndrome, Obesity, Fenofibrate, Lipoproteins, Cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jan 2001 (actual)
- Primary completion
- Apr 2002 (actual)
- Study completion
- Apr 2002 (actual)
- First posted
- 17 Jan 2007 (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.
This is a randomized placebo controlled clinical trial designed to investigate the effects of micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other characteristics of the metabolic syndrome.
Detailed description
The aim of this study was to determine the effects of micronized fenofibrate (160 mg/daily) on:
- Fasting and postprandial lipids and lipoproteins after a standarized test meal.
- Fasting and postprandial oxidized fatty acids and oxidized low density lipoprotein after a standarized test meal.
- Fasting and postprandial inflammatory mediators after a standarized test meal.
- Fasting and postprandial lipopolysaccharide-stimulated cytokine production after a standarized test meal.
- Fasting and postprandial markers of hemostasis, fibrinolysis and blood viscosity after a standarized test meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- males and postmenopausal females 18 years of age with fasting triglycerides greater than or equal to 1.7 mmol/L and <6.9 mmol/L
- two or more of the following Adult Treatment Panel III (1) criteria of the metabolic syndrome: abdominal obesity (waist circumference >89 cm in females and >102 cm in males); low high-density lipoprotein cholesterol (HDL-C) (<1.3 mmol/L in women and <1.0 mmol/L in men); hypertension (systolic blood pressure >130 or diastolic blood pressure >85 mm Hg) or current drug therapy for hypertension; and impaired fasting glucose (between 6.1 mmol/L and 7.0 mmol/L).
Key exclusion criteria (10 listed)
- included types 1 or 2 diabetes
- Body mass index >40 kg/m2
- Use of lipid-lowering therapies
- Oral hypoglycemic therapies
- Insulin
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 |
|---|---|---|
| Fenofibrate (drug) | Drug | – |
Primary outcome
1. lipids and lipoproteins
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 10 Feb 2017.
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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.
Robert S Rosenson, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fenofibrate (drug) in people with Hypertriglyceridemia With the Metabolic Syndrome, run by University of Michigan at 1 site in United States.
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 2 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 10 Feb 2017. 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 United States. 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.
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?
1. lipids and lipoproteins. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2017.