Metabolic Syndrome X Clinical Trial
Official title:
A Mechanistic Study of the Effects of LY518674 on HDL C Metabolism
Agents that increase HDL-C via reverse cholesterol transport could provide a new therapeutic
option for the prevention of atherosclerotic cardiovascular disease. The investigators
propose to investigate the effects of LY518674 on components that may likely affect
atherogenesis in patients with the metabolic syndrome including HDL-C metabolism and reverse
cholesterol transport pathways, the inflammatory response, and oxidative stress in human
subjects.
As an agonist of the nuclear peroxisome proliferator activated receptor (PPAR) alpha,
LY518674 may affect the transcription of genes that encode various proteins involved in
atherogenesis. This study will explore the consequences of altered transcription such as
changes in messenger ribonucleic acid (mRNA) and protein levels as well as protein activity.
Study Objectives
I. Primary Objective:
- To determine the effects of LY518674 on the Apo A-I production rate (calculated from
the fractional synthetic rate and the fractional catabolic rate) in subjects with the
metabolic syndrome and low HDL-C.
II. Secondary Objectives:
- To determine the effects of LY518674 on markers of reverse cholesterol transport by
analyzing changes in serum cholesterol efflux capacity (an in vitro cell-based assay).
- To determine the effects of LY518674 on the activity of lecithin cholesterol
acyltransferase (LCAT), cholesterol ester transfer protein (CETP), lipoprotein lipase,
hepatic lipase, and endothelial lipase.
- To determine the effects of LY518674 on plasma lipids, lipid subfractions, free fatty
acids, and the free fatty acid metabolite, beta-OH butyrate.
- To determine the effects of LY518674 on high-density lipoprotein (HDL), low-density
lipoprotein (LDL) and very low-density lipoprotein (VLDL) particle size using nuclear
magnetic resonance (NMR).
- To determine the effects of LY518674 on Apo A-II and Apo B-100 kinetics.
- To determine the effects of LY518674 on hsCRP.
- To determine the safety and tolerability of LY518674
Study Design:
Study H8D-MC-EMBG is a single site, randomized, placebo-controlled, double-blind, parallel
study. A minimum of 40 subjects with low HDL cholesterol and metabolic syndrome will be
randomized to receive double-blind administration of LY518674 100 mcg/day or placebo for 8
weeks. There is a safety visit every 2 weeks after treatment has been initiated, resulting
in 7 visits over 10 weeks. There are 2 inpatient visits at zero and eight weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02702375 -
Meta-analyses of Impotrant Food Sources of Sugars and Incident Cardiometabolic Diseases
|
N/A | |
| Completed |
NCT02918422 -
Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption
|
N/A | |
| Completed |
NCT02649348 -
Effects of Prehabilitation in Gastric Cancer Patients With Metabolic Syndrome on Perioperative Outcome
|
N/A | |
| Completed |
NCT02459691 -
Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos (E-LITE Latinos)
|
N/A | |
| Completed |
NCT02356952 -
Effect of a Low Glycemic Index on Metabolic Syndrome
|
N/A | |
| Completed |
NCT02337933 -
Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome
|
Phase 2 | |
| Completed |
NCT02402985 -
Comparison of a Plant Protein Diet to a Animal Protein Diet Emphasized in Type 2 Diabetics
|
N/A | |
| Completed |
NCT01694056 -
Soy Protein Intake and the Metabolic Syndrome
|
N/A | |
| Completed |
NCT00344903 -
Dallas Heart Study 2: Return Clinic Visit for the Dallas Heart Study Cohort
|
N/A | |
| Recruiting |
NCT00408824 -
Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study)
|
N/A | |
| Completed |
NCT00362908 -
Effects of Low and Moderate Fat Diets on Lipids, Inflammation and Vascular Reactivity in the Metabolic Syndrome
|
N/A | |
| Completed |
NCT00395486 -
ROMEO (Rosuvastatin in Metabolic syndrOme)
|
Phase 4 | |
| Completed |
NCT00140816 -
Dairy Products and Metabolic Effects (Norwegian Part)
|
N/A | |
| Completed |
NCT00101517 -
Partnership Programs to Reduce Ethnic Differences in the Risk of Cardiovascular Disease
|
N/A | |
| Completed |
NCT00166036 -
Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells
|
Phase 2 | |
| Completed |
NCT00455325 -
Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS)
|
Phase 2 | |
| Recruiting |
NCT00177892 -
Obstructive Sleep Apnea (OSA) and Metabolic Syndrome: Role of Oxidative Stress
|
N/A | |
| Completed |
NCT00074451 -
Genomewide Search for Loci Underlying Metabolic Syndrome
|
||
| Completed |
NCT00073775 -
Epidemiology of Stress and the Metabolic Syndrome
|
N/A | |
| Completed |
NCT00200993 -
Peripheral Effects of Exercise on Cardiovascular Health (STRRIDE I)
|
Phase 2 |