The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study

Tracking Information
First Submitted Date ICMJE	November 9, 2006
First Posted Date ICMJE	November 16, 2006
Last Update Posted Date	March 20, 2017
Study Start Date ICMJE	August 2005
Actual Primary Completion Date	December 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 5, 2007)	triglyceride levels [ Time Frame: 5 months ]
Original Primary Outcome Measures ICMJE; (submitted: November 15, 2006)	triglyceride levels
Change History	Complete list of historical versions of study NCT00400231 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 5, 2007)	HDL-C, Resistin, insulin resistance [ Time Frame: 5 months ]
Original Secondary Outcome Measures ICMJE; (submitted: November 15, 2006)	HDL-C, insulin resistance, and inflammatory markers
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study
Official Title ICMJE	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 ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Diagnostic
Condition ICMJE	Metabolic Syndrome x
Intervention ICMJE	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 Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: November 15, 2006)	124
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	March 2008
Actual Primary Completion Date	December 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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.; 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00400231
Other Study ID Numbers ICMJE	800860
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of Pennsylvania
Study Sponsor ICMJE	University of Pennsylvania
Collaborators ICMJE	Abbott
Investigators ICMJE	Principal Investigator: Frederick F. Samaha, M.D. University of Pennsylvania
PRS Account	University of Pennsylvania
Verification Date	March 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP