This study investigates whether blockade of TNF will result in reduced inflammatory indices in patients with the metabolic syndrome
Metabolic syndrome is an increasingly prevalent disorder associated with elevated risks of type II DM (diabetes mellitus) and cardiovascular morbidity and mortality. A subclinical inflammatory state is thought to contribute to the pathophysiology of metabolic syndrome, insulin resistance, and coronary artery disease (CAD). TNF-alpha is an inflammatory cytokine that is increased in a spectrum of inflammatory diseases as well as in insulin resistance. TNF-alpha antagonists are clinically effective in the inflammation of arthritides, but have not been examined in the metabolic syndrome population. Moreover, data suggests that adiponectin, a recently discovered adipocytokine that may protect against the development of insulin resistance and atherosclerosis, may be downregulated by TNF-alpha. We propose a study in which we administer etanercept, a TNF-alpha receptor fusion protein, to subjects with metabolic syndrome to examine its effect on inflammatory markers,CRP, adiponectin and insulin resistance. This would be the first study to investigate the anti-inflammatory properties and insulin sensitizing potential of TNF-alpha blockade on the growing population with metabolic syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
50 mg SC q week
SC q week
MGH
Boston, Massachusetts, United States
CRP
Time frame: 4 weeks
Insulin resistance
Time frame: 4 weeks
Muscle adiposity
Time frame: 4 weeks
High molecular weight adiponectin
Time frame: 4 weeks
resistin
Time frame: 4 weeks
leptin
Time frame: 4 weeks
TNF-R1
Time frame: 4 weeks
TNF-R2
Time frame: 4 weeks
weight
Time frame: 4 weeks
WBC
Time frame: 4 weeks
Lipids
Time frame: 4 weeks
IL-6
Time frame: 4 weeks
Fibrinogen
Time frame: 4 weeks
adiponectin
Time frame: 4 weeks
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