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The Fenofibrate and Metformin for Atherogenic Dyslipidemia (FAMA) Study

NCT00400231 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2017-03-20

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Frederick F. Samaha, M.D. · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2007-12-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00400231 on ClinicalTrials.gov