Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

This study is currently recruiting participants.
Verified August 2012 by Gachon University Gil Medical Center
Information provided by:
Gachon University Gil Medical Center Identifier:
First received: August 15, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted

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

Condition Intervention Phase
Drug: placebo
Drug: fenofibrate/omega
Drug: fenofibrate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • flow-mediated dilation [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin resistance [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
Active Comparator: fenofibrate/omega Drug: fenofibrate/omega
Active Comparator: fenofibrate Drug: fenofibrate


Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • hypertriglyceridemia

Exclusion Criteria:

  • moderate or severe hypertension, uncontrolled diabetes (HbA1c > 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease
  Contacts and Locations
Please refer to this study by its identifier: NCT01666041

Contact: Kwang K Koh, MD,PhD

Korea, Republic of
Gil Medical Center Recruiting
Incheon, Korea, Republic of, 405-760
Contact: Seung Han, MD   
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

No publications provided Identifier: NCT01666041     History of Changes
Other Study ID Numbers: GMC-201202
Study First Received: August 15, 2012
Last Updated: August 15, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:
insulin resistance

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses processed this record on April 17, 2014