Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia
HypertriglyceridemiaDyslipidemiaOnce a day oral administration with DCCR helps lower triglycerides
Lovaza® and Microvascular Function in Type 2 Diabetes
HypertriglyceridemiaDiabetic NeuropathyThe objective of this study is to determine the efficacy of 6 months of 4 g/day oral Lovaza® on endothelial-dependent and heat-induced vasodilation in type 2 diabetics with neuropathy and elevated triglyceride levels. Omega-3 fatty acids appear to exert beneficial effects on vascular function that are independent of the changes in serum triglycerides. The efficacy will be compared with a placebo given at the same duration. Efficacy of the drug will be evaluated after 3 and 6 months of treatment. This timeline should be adequate for evaluation of the primary neurophysiological endpoints. Previously, the investigators have demonstrated that it is feasible to pharmacologically alter nerve fiber density in as little as 18 weeks and that this correlates with subjective and objective measures of neurovascular function. The investigators are predicting an enhancement of post-ischemic hyperemia of the foot dorsum, where the dilative mechanism is primarily endothelium-dependent and a similar improvement in heat-induced hyperemia.
Open-Label Extension of a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy...
HypertriglyceridemiaIn a previous trial (LOV111858/OM6), subjects received in a double-blind fashion either 4 g/day of Lovaza® (omega-3-ethyl esters) [formerly known as Omacor] co-administered with simvastatin 40 mg/day or placebo co-administered with simvastatin 40 mg/day for 8 weeks. This extension trial, LOV111818/OM6X assessed the continued efficacy and safety of Lovaza® (omega-3-ethyl esters) co-administered with simvastatin 40 mg vs. switching from simvastatin plus placebo to simvastatin plus Lovaza® for lowering non-High Density Lipoprotein-Cholesterol (non-HDL-C) levels at 4 months (primary endpoint) and additionally at 12 and 24 months.
Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators...
Hypertriglyceridemia With the Metabolic SyndromeThis is a randomized placebo controlled clinical trial designed to investigate the effects of micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other characteristics of the metabolic syndrome.
Effect of Soluble Fiber on Hypertriglyceridemia and Immune Profile in HIV-positive Individuals....
HypertriglyceridemiaHIV InfectionsThe purpose of this study was to assess the effect of soluble fiber® (partially hydrolyzed guar gum) supplementation on hypertriglyceridemia and immune profile in HIV-positive individuals on HAART.
Evaluation of Safety and Effects of SLx-4090 After Dosing for 14 Days in Subjects With High Triglycerides...
HypertriglyceridemiaThe purpose is to investigate the effect of oral doses of SLx-4090 over 14 days on subjects with high triglycerides.
Pharmacological Regulation of Fat Transport in Metabolic Syndrome
ObesityLipid Disorders2 moreThe purpose of this study is to determine whether atorvastatin and fenofibrate are effective in the treatment of lipid disorders in obese, insulin resistant subjects.
Open-label Pharmacokinetic Study of Diazoxide Choline Coated vs. Uncoated Formulations
HypertriglyceridemiaThis is a single-center, randomized, open-label, multi-dose crossover study assessing the pharmacokinetic profiles of diazoxide choline coated versus uncoated formulations in healthy volunteers. The primary objective is to compare the pharmacokinetic (PK) profiles of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers under fed conditions. Secondary objectives are to assess diazoxide choline pharmacokinetic (PK) parameters under fasted conditions, and to assess the safety and tolerability of diazoxide choline controlled-release coated tablets versus uncoated tablets in healthy volunteers.
Niacin, N-3 Fatty Acids and Insulin Resistance
Metabolic SyndromeHypertriglyceridemiaThis research study is being conducted to test the effects of two drugs on blood lipids (cholesterol and triglycerides) and blood sugar (glucose) levels in patients with diabetes or "pre-diabetes" (both of which have a condition called "insulin-resistance"). These products are Niaspan (extended release nicotinic acid) and Omacor (omega-3 acid ethyl esters). We hypothesize that the combination of Niaspan and Omacor will reduce serum triglyceride levels, increase HDL-cholesterol levels and do so without altering glucose levels.
Study of Ezetimibe and Fenofibrate in Patients With Mixed Hyperlipidemia (0653-036)(COMPLETED)
HypercholesterolemiaHypertriglyceridemiaThe purpose of this study is to assess the cholesterol lowering safety and effectiveness of two investigational drugs in patients with mixed hyperlipidemia (high cholesterol and high triglycerides).