Comparing Tricor, Avandia, or Weight Loss to Lower Cardiovascular Risk Factors in People With High Triglycerides. - NCT00186537-94305(Clinical Trial 129378)
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Stanford |
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State:
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CA |
| Zip Code: |
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94305 |
| Conditions: |
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Insulin Resistance - Hypertriglyceridemia |
| Purpose: |
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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.
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| Study summary: |
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It has been estimated that approximately ¼ of the US population has the Insulin Resistant
Syndrome (IRS). The notion that insulin resistance and compensatory hyperinsulinemia lead
to a cluster of abnormalities that increase CVD risk was first introduced in 1988, and
central to the changes identified was a dyslipidemia characterized by a high plasma
triglyceride (TG) and low high-density lipoprotein cholesterol (HDL-C) concentration. The
atherogenic lipoprotein pattern associated with the IRS has grown to include enhanced
postprandial lipemia and smaller and denser low-density lipoprotein (LDL) particles. In
addition to being associated with insulin resistance and compensatory hyperinsulinemia,
these changes in lipoprotein metabolism have been identified as increasing CVD risk. The
power of the dyslipidemia associated with the IRS is reinforced by reports that the plasma
TG/HDL-C concentration ratio is as powerful a predictor of CVD, if not more so, than the
more conventional total plasma cholesterol/LDL-C concentration ratio, and evidence from the
Copenhagen Male Study of the interaction between the plasma TG and HDL-C concentrations,
“conventional” CVD risk factors, and CVD events. Specifically, these latter investigators
were able to show in a prospective study (11) that CVD events were substantially attenuated
in: 1) smokers; 2) patients with high blood pressure; 3) individuals with a high LDL-C
concentration; and 4) subjects who were sedentary; as long as they were in the lowest 1/3rd
of the population with the lowest TG/HDL-C concentration ratio and presumably insulin
sensitive. Conversely, if they were in the tertile with the highest plasma TG/HDL-C
concentration ratio, and presumably insulin resistant, they had a significant increase in
CVD events in the absence of the four conventional CVD risk factors evaluated.
An obvious alternative therapeutic approach to decreasing CVD risk in patients with the IRS
would be to administer a thiazolidinedione (TZD) compound in an effort to directly treat the
basic defect of the syndrome. However, based upon our own results with rosiglitazone (ROSI)
in several different patient populations, improvements in insulin sensitivity were not
associated with a significant improvement in dyslipidemia. For example, in a recent study
(unpublished) of ROSI-treated patients with type 2 diabetes, neither plasma TG (358 to 347
mg/dL) nor HDL-C (40 to 42 mg/dL) concentrations improved, and both total (215 to 239 mg/dL
and LDL-C (118-142mg/dL) concentrations actually increased. Since the patients in this
study became more insulin sensitive with treatment, and had lower daylong plasma glucose,
insulin, and free fatty acid concentrations, the reason for the lack of a beneficial effect
of ROSI on lipoprotein metabolism is not clear. On the other hand, given evidence of the
importance of dyslipidemia in increasing CVD risk in insulin resistant individuals, it seems
reasonable to question the notion that TZD compounds provide the most beneficial approach
to decreasing CVD risk in the dyslipidemic patient with the IRS.
With this background in mind, we propose to initiate a study in which insulin resistant
individuals with the dyslipidemia characteristic of the IRS will be randomized to treatment
with fenofibrate,ROSI, or weight loss and the effect of these three treatments on CVD risk
factors compared. It is postulated that although insulin resistance will improve to a
greater degree with ROSI treatment, the atherogenic lipoprotein profile known to link IRS
and CVD will only significantly improve following treatment with fenofibrate and effects of
weight loss can effect both of these. |
| Criteria: |
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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 |
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| Study is available at: |
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Stanford University Medical Center
Stanford, CA 94305
United States
Primary Contact:
Cynthia A Lamendola, MSN/ANP
Phone: 650-723-7024
Secondary Contact:
Cynthia A Lamendola, MSN/ ANP
Phone: 650-723-7024 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
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above to view all information about this clinical trial. |
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