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Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01666041
Enrollment
120
Registered
2012-08-16
Start date
2012-01-31
Completion date
2013-07-31
Last updated
2014-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia

Keywords

insulin resistance

Brief summary

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

Interventions

DRUGplacebo
DRUGfenofibrate/omega
DRUGfenofibrate

Sponsors

Gachon University Gil Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
25 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
flow-mediated dilation8 weeks of treatment

Secondary

MeasureTime frame
insulin resistance8 weeks of treatment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026