At a glance
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Free Fatty Acid-Induced Hypertension in Obese Subjects With Type 2 Diabetes
In Brief
A Phase 4 clinical trial evaluating Rosiglitazone, Normal saline 0.9%, and 1 other intervention for Type 2 Diabetes and Hypertension. Completed, enrolled 36 participants across 1 site.
Detailed Summary
Insulin resistance has been implicated as the central pathogenetic feature of cardiovascular risk factor cluster that includes hypertension, impaired glucose tolerance, diabetes, dyslipidemia, and hemostatic disorders. Recent evidence suggests that increased levels of free fatty acids (FFA) in obese subjects is a leading candidate in the pathogenesis of insulin resistance (1-4). In our preliminary studies on the effect of FFA on insulin secretion and action (lipotoxicity), we have observed that the infusion of Intralipid/heparin to increase FFA \~ four-fold-baseline levels for 48 hours results in a significant and reproducible raise in systolic and diastolic blood pressure (BP) in obese African American subjects with and without diabetes. The increase in blood pressure is apparent after 12 hours of infusion, reaching a peak increment of 32 mm Hg in systolic and 14 mm Hg in diastolic pressure at 24 hours. These preliminary findings indicate that, in addition to the well-known effect on insulin resistance, sustained elevation of FFA results in the development of an acute metabolic syndrome.
Study Details
Timeline
Interventions
Diabetic subjects will be receive rosiglitazone for 6 weeks
Normal saline 0.9% intravenous infusion at 40ml/hr for 48 hours
Intralipid 20% at 40ml/hr intravenously for 48 hours