The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by University of Pennsylvania.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00400231
First received: November 9, 2006
Last updated: January 8, 2008
Last verified: January 2008

November 9, 2006
January 8, 2008
August 2005
March 2008   (final data collection date for primary outcome measure)
triglyceride levels [ Time Frame: 5 months ] [ Designated as safety issue: No ]
triglyceride levels
Complete list of historical versions of study NCT00400231 on ClinicalTrials.gov Archive Site
HDL-C, Resistin, insulin resistance [ Time Frame: 5 months ] [ Designated as safety issue: No ]
HDL-C, insulin resistance, and inflammatory markers
Not Provided
Not Provided
 
The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study
The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Metabolic Syndrome X
  • 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
  • Active Comparator: 1
    Metformin
    Intervention: Drug: Study Drug: Metformin
  • Active Comparator: 2
    Fenofibrate
    Intervention: Drug: Study Drug: fenofibrate
  • Active Comparator: 3
    Fenofibrate and Metformin
    Intervention: Drug: Study drugs: Metformin and fenofibrate
  • Placebo Comparator: 4
    Intervention: Drug: Metformin and Fenofibrate placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
124
November 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00400231
800860
Not Provided
Frederick F. Samaha, MD, UPenn
University of Pennsylvania
Abbott
Principal Investigator: Frederick F. Samaha, M.D. University of Pennsylvania
University of Pennsylvania
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP