Metabolic Syndrome Clinical Trial
Official title:
Effects of Activation of the Farnesoid X Receptor (FXR) on Hepatic Lipid and Glucose Metabolism in Patients With the Metabolic Syndrome and Familial Forms of Hypertriglyceridemia
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.
Insulin resistance has been found to be the key pathophysiological factor of the metabolic
syndrome and may precede the onset of impaired glucose tolerance, diabetes and dyslipidemia.
Recently, nonalcoholic fatty liver disease (NAFLD), has been identified as another feature
of this syndrome. Importantly, a close relation between liver fat content and hepatic
insulin sensitivity has been described. We hypothesize that activation of FXR with
chenodeoxycholic acid decreases hepatic de novo lipogenesis and subsequently hepatic fat
content and triglyceride production. The decrease in liver fat content will be associated
with improved hepatic insulin sensitivity and a decrease in hepatic glucose production.
Patients diagnosed with metabolic syndrome, familial hypertriglyceridemia or familial
combined hyperlipidemia will be recruited from the the outpatients department of the
Division of Endocrinology, Diabetology and Clinical Nutrition, University Hospital Basel.
Eligible patients will be admitted to the CRC for metabolic studies, including baseline
blood samples for the measurement of hormones, cytokines and adipokines,
euglycemic-hyperinsulinemic clamp studies for the assessment of glucose turnover and insulin
sensitivity and in vivo NMR studies to determine intrahepatic and intramyocellular lipid
content. Patients will alternatively receive chenodeoxycholic acid and placebo. The study
population will be compared to a group of age, gender and weight matched normolipidemic
controls.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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