Effects of Interleukin-1 Beta on Low Testosterone Levels in Men With Obesity and Metabolic Syndrome
Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Mirjam Christ-Crain University Hospital, Basel, Switzerland
Treatments:
Interleukin 1 Receptor Antagonist Protein Testosterone