N/A
N=47
Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides.
Insulin Resistance · Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT00186537 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Pre- and Post-Intervention Triglyceride Levels — 231; 209; 201; 140 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rosiglitazone (Drug); Fenofibrate (Drug); Weight Loss (Behavioral)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre- and Post-Intervention Triglyceride Levels |
231; 209; 201; 140; 232; 143 | — |
| PRIMARY Pre- and Post-Intervention LDL Cholesterol Levels |
114; 119; 144; 111; 129; 128 | — |
| PRIMARY Pre- and Post-Intervention HDL Cholesterol Levels |
35; 40; 38; 36; 42; 38 | — |
Summary
Approximately 1/4 of the US population has insulin resistance and the associated risk factors such as elevated lipid levels -triglycerides (type of fat from what we eat and what the liver produces and low HDL cholesterol which is the good cholesterol helping to protect against heart disease. Currently one known treatment for this a medication called fenofibrate, another medication that can improve insulin resistance is rosiglitazone, a third treatment known to improve insulin resistance an decrease triglycerides is weight loss. In this study insulin resistant individuals with elevated triglycerides and or a ratio of triglycerides to HDL cholesterol of 3:1 or greater will be randomized (selected by chance) to receive one of these treatments and results of insulin sensitivity and cardiac risk profiles will be compared at the end of the study.
Eligibility Criteria
Inclusion Criteria
Insulin Resistant Triglyceride 150 mg/dL or greater or triglyceride HDL-C ratio 3 or greater BMI 25-35
Exclusion Criteria
Diabetes Mellitus History of gall stones History of CHF History of CAD Severe anemia,kidney, or liver disease
Data sourced from ClinicalTrials.gov (NCT00186537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.