Effects of FXR Activation on Hepatic Lipid and Glucose Metabolism (NCT00465751) | Clinical Trial Compass
CompletedEarly Phase 1
Effects of FXR Activation on Hepatic Lipid and Glucose Metabolism
Switzerland30 participantsStarted 2004-10
Plain-language summary
The purpose of this study is to determine whether chenodeoxycholic acid decreases de novo hepatic lipogenesis, hepatic fat content, hepatic triglyceride production and plasma triglyceride concentrations and improves hepatic glucose metabolism in patients with the metabolic syndrome, Familial Hypertriglyceridemia and Familial Combined Hyperlipidemia.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age between 18 and 65 years.
✓. Patients with a metabolic syndrome defined by the presence of \>= 3 of the following criteria:
✓. Patients with Familial Combined Hyperlipidemia characterized by the following criteria:
✓. Patients with Familial Hypertriglyceridemia characterized by the following criteria:
✓. Controls fulfilling the following criteria:
Exclusion criteria
✕. Any significant hepatic, cardiac, pulmonary, renal, neurological, musculoskeletal, hematological or endocrine disease.
✕. Any form of primary or secondary hyperlipidemia other than the metabolic syndrome, FHTG or FCHL. \[These may include: Familial hypercholesterolemia and Familial defective apolipoprotein B (to be assessed by family history and lipid profiles), and Familial Dysbetalipoproteinemia (to be assessed by apo E genotyping), hypothyroidism, nephrotic syndrome, diabetes mellitus, cholestatic liver disease, drug induced hyperlipidemia (thiazides \> 25 mg/d, non cardioselective betablockers, isotretinoin, systemic glucocorticoids, cyclosporin A, tacrolimus, non nucleoside HIV protease inhibitors)\].
✕. Plasma TG levels \> 12 mmol/l in the past or at any time point during the study.
✕. History of acute pancreatitis
✕. History of cardiovascular disease, i.e. coronary artery disease, cerebrovascular disease, peripheral vascular disease, when assessed by medical history, physical exam. Additionally, a stress test will be performed in subjects with MS and FCHL at risk for CHD (see below).