Metabolic Syndrome xPhase 2NCT00400231
The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study
A Phase 2 study testing Study drugs: Metformin and fenofibrate, Study Drug: Metformin and Study Drug: fenofibrate in people with Metabolic Syndrome x, run by University of Pennsylvania at 1 site in United States.
Trial summary
Patients with metabolic syndrome, insulin resistance, and elevated triglycerides of 150 mg/dl or higher will be randomized to one of four groups: 1) placebo; 2) metformin; 3) fenofibrate; or 4) combined metformin and fenofibrate for a period of 12 weeks after titration to target dose. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome x
- What is being tested?
- Study drugs: Metformin and fenofibrate, Study Drug: Metformin and Study Drug: fenofibrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Mar 2008
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects between the ages of 18 and 75 with both of the following risk factors:
- Fasting triglycerides >= 150 mg/dl (but less than 800 mg/dl)
- Glucose of 140 to 199 mg/dl, 2 hours after a 75 gm oral glucose load, a fasting HOMA level in the upper quartile (> 2.68), or a plasma triglyceride to high density lipoprotein cholesterol concentration > 3.0
- And at least one of the following three:
- Central obesity (waist size > 40 inches in men or >35 inches in women)
- A systolic blood Pressure of >130 mmHg and/or a diastolic blood pressure of >85 mmHg and/or taking an antihypertensive medication.
- HDL < 40 mg/dl for men or < 50 mg/dl for women
Who cannot join
- Blood pressure > 180/95 mmHg (subjects may be re-screened after adequate blood pressure control has been obtained)
- Women who are pregnant or lactating, or who are of child-bearing potential and not using an acceptable method of birth control.
- Chronic renal insufficiency (serum creatinine >1.5 mg/dl in men and > 1.4 mg/dl in women
- Any active liver disease or abnormal LFTs (>2x upper limit normal)(12)
- Active infection, malignancy or chronic inflammatory disorder
- Concomitant use of niacin, a bile acid sequestrant, or ezetimibe. If it is deemed safe by the patient's primary physician and by the principal investigator, patients may be screened for enrollment upon stopping these medications for at least 2 weeks.
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- Subjects on statins will need to be on less than maximal dose (e.g. < 80 mg per day for simvastatin or atorvastatin). Subjects will also need to have been on a stable dose of statin therapy for at least 1 month prior to enrollment and continue their currently prescribed statin at the same dose throughout the study. If it is deemed safe by the patient's primary physician and by the principal investigator, patients on maximal statin therapy (usually 80 mg/day) may reduce their dose of statin therapy to a sub maximal dose (usually 40 mg/day) for 4 weeks prior to screening for enrollment.
- History of lactic acidosis(12)
- Expected need for use of intravenous radiographic contrast during the study
- More than moderate alcohol use (> 14 drinks per week)
- Moderate to severe left ventricular dysfunction (ejection fraction <45%)
- Decompensated heart failure or decompensated lung disease that has resulted in hypoxia or reduced peripheral perfusion within the past year regardless of left ventricular ejection fraction (thus patients with underlying heart disease, coronary artery disease, mild left ventricular dysfunction (ejection fraction > 45%), or lung disease that has been stable for at least one year will be eligible to participate)
- Creatinine kinase (CK) levels ≥ 2.5 ULN or history of statin-induced myopathy. Patients with a CK level more than 2.5 times the upper limit of normal may undergo repeat testing up to two more times before being excluded (since vigorous physical activity can often elevate CK levels, and this would not increase the risk of myopathy).
- Participation in an investigational drug study within 6 weeks prior to the screening visit
- Surgery within the previous 30 days
- Concomitant use of ketoconazole, itraconazole, cyclosporin A, erythromycin, or Clarithromycin.
- Hemoglobin < 10 mg/dl, active use of coumadin, history of bleeding disorder, or abnormal clotting time (protime >14.6 seconds and aPTT > 37.0)
- Septic shock
- Acute coronary syndrome or stroke within 3 months prior to study
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Patients with metabolic syndrome, insulin resistance, and elevated triglycerides of 150 mg/dl or higher will be randomized to one of four groups: 1) placebo; 2) metformin; 3) fenofibrate; or 4) combined metformin and fenofibrate for a period of 12 weeks after titration to target dose. We are interested in the effects of these therapies on triglyceride levels, HDL-C, insulin resistance, and markers of inflammation.
- Conditions
- Metabolic Syndrome x
- Being tested
- Study drugs: Metformin and fenofibrate, Study Drug: Metformin, Study Drug: fenofibrate, Metformin and Fenofibrate placebo
- Keywords
- metabolic syndrome, Triglycerides, Insulin Resistance, inflammation, Cardiovascular Disease, Elevated triglycerides, without diabetes
- Medical subject headings
- Metabolic Syndrome, Insulin Resistance, Inflammation, Cardiovascular Diseases, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study drugs: Metformin and fenofibrateDrug
145mg fenofibrate once/day and 2000mg/day of metformin for arm 3.
Study Drug: MetforminDrug
2000mg/day
Study Drug: fenofibrateDrug
145mg/day of fenofibrate
Metformin and Fenofibrate placeboDrug
placebo metformin and fenofibrate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Metformin Receives: Drug: Study Drug: Metformin |
| 2 | Active comparator | Fenofibrate Receives: Drug: Study Drug: fenofibrate |
| 3 | Active comparator | Fenofibrate and Metformin Receives: Drug: Study drugs: Metformin and fenofibrate |
| 4 | Placebo comparator | Not described Receives: Drug: Metformin and Fenofibrate placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
triglyceride levels
Measured: 5 months
Secondary outcomes (1)
HDL-C, Resistin, insulin resistance
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startAug 2005
- Primary completionDec 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome xStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Frederick F. Samaha, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400231
- Sponsor's protocol ID
- 800860
- Status last verified
- Mar 2017
- First submitted
- 9 Nov 2006
- Last updated
- 20 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study
- ClinicalTrials.gov ID
- NCT00400231
- Acronym / sponsor ID
- 800860
- Conditions
- Metabolic Syndrome x
- Keywords
- metabolic syndrome, Triglycerides, Insulin Resistance, inflammation, Cardiovascular Disease, Elevated triglycerides, without diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Aug 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 16 Nov 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.
Patients with metabolic syndrome, insulin resistance, and elevated triglycerides of 150 mg/dl or higher will be randomized to one of four groups: 1) placebo; 2) metformin; 3) fenofibrate; or 4) combined metformin and fenofibrate for a period of 12 weeks after titration to target dose. We are interested in the effects of these therapies on triglyceride levels, HDL-C, insulin resistance, and markers of inflammation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Study Drug: MetforminMetformin |
| 2 | Active comparator | Drug: Study Drug: fenofibrateFenofibrate |
| 3 | Active comparator | Drug: Study drugs: Metformin and fenofibrateFenofibrate and Metformin |
| 4 | Placebo comparator | Drug: Metformin and Fenofibrate placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fasting triglycerides >= 150 mg/dl (but less than 800 mg/dl)
- Glucose of 140 to 199 mg/dl, 2 hours after a 75 gm oral glucose load, a fasting HOMA level in the upper quartile (> 2.68), or a plasma triglyceride to high density lipoprotein cholesterol concentration > 3.0
- Central obesity (waist size > 40 inches in men or >35 inches in women)
- A systolic blood Pressure of >130 mmHg and/or a diastolic blood pressure of >85 mmHg and/or taking an antihypertensive medication.
- HDL < 40 mg/dl for men or < 50 mg/dl for women
Key exclusion criteria (20 listed)
- Blood pressure > 180/95 mmHg (subjects may be re-screened after adequate blood pressure control has been obtained)
- Women who are pregnant or lactating, or who are of child-bearing potential and not using an acceptable method of birth control.
- Chronic renal insufficiency (serum creatinine >1.5 mg/dl in men and > 1.4 mg/dl in women
- Any active liver disease or abnormal LFTs (>2x upper limit normal)(12)
- Active infection, malignancy or chronic inflammatory disorder
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 |
|---|---|---|
| Study drugs: Metformin and fenofibrate145mg fenofibrate once/day and 2000mg/day of metformin for arm 3. | Drug | 3 |
| Study Drug: Metformin2000mg/day | Drug | 1 |
| Study Drug: fenofibrate145mg/day of fenofibrate | Drug | 2 |
| Metformin and Fenofibrate placeboplacebo metformin and fenofibrate | Drug | 4 |
Primary outcome
triglyceride levels
Time frame: 5 months
1 secondary outcome
HDL-C, Resistin, insulin resistance
Time frame: 5 months
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 20 Mar 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.
Frederick F. Samaha, M.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Study drugs: Metformin and fenofibrate, Study Drug: Metformin and Study Drug: fenofibrate in people with Metabolic Syndrome x, run by University of Pennsylvania 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 7 inclusion and 20 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 20 Mar 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
triglyceride levels (time frame: 5 months). 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 20 Mar 2017.