The purpose of this study is to determine whether the liver is exposed to excessive amounts of fat present in the bloodstream in obese and non-obese individuals with and without noninsulin-dependent diabetes mellitus. The results of the study indicate that hepatic FFA delivery is increased in obesity, but that visceral fat plays a significant role in increasing hepatic FFA delivery primarily in obese women. We found a positive correlation between visceral fat mass and the percentage of FFA delivered to the liver from visceral lipolysis in women, but did not find this relationship in men. The positive results from this study were important preliminary data for the competing renewal for DK 40484. We believe we have completed volunteer recruitment for this study. The weight loss portion of this study that included a randomized, placebo-controlled, blinded assignment of overweight volunteers to fenfluramine/phentermine was discontinued because of valvular heart disease. All volunteers have been removed from the medication and are being followed with echocardiography. Results of the studies have been analyzed. Pending the completion of animal studies to validate the model we used to estimate hepatic FFA delivery, the results of the studies will be submitted for publication.
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