NCT00400231

The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Metabolic Syndrome x

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-12-01
• Completion: 2008-03-01
• First posted: 2006-11-16
• Last updated: 2017-03-20

Locations

1 site across 1 country: United States