Obesity Clinical Trial
Official title:
Effects of IL-1 Beta on the Hypothalamic-pituitary-gonadal (HPG) Axis in Men With Obesity and Metabolic Syndrome - The TestIL Trial
Obesity and the metabolic syndrome in men are associated with a high prevalence of hypogonadism of up to 50%. Increased fat mass leads to augmented release of adipocytokines and pro-inflammatory cytokines such as IL-1-beta, IL-6 and tumor necrosis factor-alpha which in turn suppress the hypothalamic-pituitary-gonadal (HPG) axis, leading to hypogonadism. This pathophysiological interplay is termed hypogonadal-obesity-adipocytokine hypothesis. TestIL is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to test the hypothesis that inhibition of IL-1-activity diminishes the inhibitory effects on HPG axis and increases testosterone levels in men with metabolic syndrome.
Obesity and the metabolic syndrome are considered as chronic low-grade inflammatory states.
Elevated pro-inflammatory mediators in obesity and metabolic syndrome have an inhibitory
effect on the hypothalamic-pituitary-gonadal axis (HPG axis) leading to hypogonadism.
Decreased testosterone production in obese men in turn promotes additional fat deposition,
contributing to a vicious cycle of fat accumulation. This complex pathophysiological
interplay is termed hypogonadal-obesity-adipocytokine hypothesis, describing a bidirectional
relationship between low levels of testosterone and the metabolic syndrome.
TestIL is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to
test the hypothesis that inhibition of IL-1-activity diminishes the inhibitory effects on HPG
axis and increases testosterone levels in men with metabolic syndrome.
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