The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study

Metabolic Syndrome x Clinical Trial

Official title:

The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400231
• Other study ID #: 800860
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2006
• Last updated: March 16, 2017
• Start date: August 2005
• Est. completion date: March 2008

Study information

• Verified date: March 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. We are interested in the effects of these therapies on triglyceride levels, HDL-C, insulin resistance, and markers of inflammation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Metabolic Syndrome x

Intervention

Drug:
• Study drugs: Metformin and fenofibrate
145mg fenofibrate once/day and 2000mg/day of metformin for arm 3.
• Study Drug: Metformin
2000mg/day
• Study Drug: fenofibrate
145mg/day of fenofibrate
• Metformin and Fenofibrate placebo
placebo metformin and fenofibrate

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	triglyceride levels		5 months
Secondary	HDL-C, Resistin, insulin resistance		5 months