Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

Phase 4

Completed

• Conditions: Hypertriglyceridemia
• Interventions: Drug: fenofibrate/omega; Drug: placebo; Drug: fenofibrate

• Registration Number: NCT01666041
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

The investigators hypothesize that fenofibrate/omega will improve insulin resistance compared with fenofibrate

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-08
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-16
• Primary Completion: 2013-02
• Study Completion: 2013-07
• Last Update Submitted: 2014-11-01
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• hypertriglyceridemia

Exclusion Criteria

• moderate or severe hypertension, uncontrolled diabetes (HbA1c > 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fenofibrate/omega	fenofibrate/omega	fenofibrate/omega
placebo	placebo	placebo
fenofibrate	fenofibrate	fenofibrate

Primary Outcome Measures

Name	Time	Method
flow-mediated dilation	8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
insulin resistance	8 weeks of treatment

Trial Locations

Locations (1)

Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of