The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Metabolic Syndrome X |
| Intervention | Drug: Study drugs: Metformin and fenofibrate Drug: Study Drug: Metformin Drug: Study Drug: fenofibrate Drug: Metformin and Fenofibrate placebo |
| Phase | Phase 2 |
| Sponsor | University of Pennsylvania |
| Responsible Party | University of Pennsylvania |
| ClinicalTrials.gov Identifier | NCT00400231 |
| First Received | November 9, 2006 |
| Last Updated | January 8, 2008 |
| Last verified | January 2008 |
Tracking Information[ + expand ][ + ]
| First Received Date | November 9, 2006 |
|---|---|
| Last Updated Date | January 8, 2008 |
| Start Date | August 2005 |
| Estimated Primary Completion Date | November 2008 |
| Current Primary Outcome Measures | triglyceride levels [Time Frame: 5 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | HDL-C, Resistin, insulin resistance [Time Frame: 5 months] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study |
|---|---|
| Official Title | The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study |
| Brief 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. We are interested in the effects of these therapies on triglyceride levels, HDL-C, insulin resistance, and markers of inflammation. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic |
| Condition | Metabolic Syndrome X |
| Intervention | Drug: Study drugs: Metformin and fenofibrate 145mg fenofibrate once/day and 2000mg/day of metformin for arm 3. Drug: Study Drug: Metformin 2000mg/day Drug: Study Drug: fenofibrate 145mg/day of fenofibrate Drug: Metformin and Fenofibrate placebo placebo metformin and fenofibrate |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 124 |
| Estimated Completion Date | November 2008 |
| Estimated Primary Completion Date | March 2008 |
| Eligibility Criteria | Inclusion Criteria: Subjects between the ages of 18 and 75 with both of the following risk factors: 1. Fasting triglycerides >= 150 mg/dl (but less than 800 mg/dl) 2. 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: 1. Central obesity (waist size > 40 inches in men or >35 inches in women) 2. A systolic blood Pressure of >130 mmHg and/or a diastolic blood pressure of >85 mmHg and/or taking an antihypertensive medication. 3. HDL < 40 mg/dl for men or < 50 mg/dl for women Exclusion Criteria: 1. Blood pressure > 180/95 mmHg (subjects may be re-screened after adequate blood pressure control has been obtained) 2. Women who are pregnant or lactating, or who are of child-bearing potential and not using an acceptable method of birth control. 3. Chronic renal insufficiency (serum creatinine >1.5 mg/dl in men and > 1.4 mg/dl in women 4. Any active liver disease or abnormal LFTs (>2x upper limit normal)(12) 5. Active infection, malignancy or chronic inflammatory disorder 6. 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. 7. 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. 8. History of lactic acidosis(12) 9. Expected need for use of intravenous radiographic contrast during the study 10. More than moderate alcohol use (> 14 drinks per week) 11. Moderate to severe left ventricular dysfunction (ejection fraction <45%) 12. 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) 13. 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). 14. Participation in an investigational drug study within 6 weeks prior to the screening visit 15. Surgery within the previous 30 days 16. Concomitant use of ketoconazole, itraconazole, cyclosporin A, erythromycin, or Clarithromycin. 17. Hemoglobin < 10 mg/dl, active use of coumadin, history of bleeding disorder, or abnormal clotting time (protime >14.6 seconds and aPTT > 37.0) 18. Septic shock 19. Acute coronary syndrome or stroke within 3 months prior to study 20. 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00400231 |
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| Other Study ID Numbers | 800860 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | University of Pennsylvania |
| Study Sponsor | University of Pennsylvania |
| Collaborators | Abbott |
| Investigators | Principal Investigator: Frederick F. Samaha, M.D. University of Pennsylvania |
| Verification Date | January 2008 |
Locations[ + expand ][ + ]
| University of Pennsylvania | Philadelphia, Pennsylvania, United States, 19104 |
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