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
  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.


Condition Intervention Phase
Metabolic Syndrome X
Drug: Study drugs: Metformin and fenofibrate
Drug: Study Drug: Metformin
Drug: Study Drug: fenofibrate
Drug: Metformin and Fenofibrate placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • triglyceride levels [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HDL-C, Resistin, insulin resistance [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: August 2005
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Metformin
Drug: Study Drug: Metformin
2000mg/day
Active Comparator: 2
Fenofibrate
Drug: Study Drug: fenofibrate
145mg/day of fenofibrate
Active Comparator: 3
Fenofibrate and Metformin
Drug: Study drugs: Metformin and fenofibrate
145mg fenofibrate once/day and 2000mg/day of metformin for arm 3.
Placebo Comparator: 4 Drug: Metformin and Fenofibrate placebo
placebo metformin and fenofibrate

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400231

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Abbott
Investigators
Principal Investigator: Frederick F. Samaha, M.D. University of Pennsylvania
  More Information

No publications provided

Responsible Party: Frederick F. Samaha, MD, UPenn
ClinicalTrials.gov Identifier: NCT00400231     History of Changes
Other Study ID Numbers: 800860
Study First Received: November 9, 2006
Last Updated: January 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
metabolic syndrome
Triglycerides
Insulin Resistance
inflammation
Cardiovascular Disease
Elevated triglycerides
without diabetes

Additional relevant MeSH terms:
Dyslipidemias
Metabolic Syndrome X
Lipid Metabolism Disorders
Metabolic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metformin
Fenofibrate
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014