Effects of Interleukin-1 Beta on Low Testosterone Levels in Men With Obesity and Metabolic Syndrome

Exclusion Criteria

• •1. Previous or current medication with testosterone,
• •2. Testosterone deficiency of other cause, i.e. primary hypogonadism caused e.g. by Klinefelters syndrome, cryptorchidism, condition following orchiectomy. Known secondary hypogonadism caused by pituitary adenoma. Patients on antiandrogen medication,
• •3. Clinical signs of infection in the week before inclusion or history of a severe infection during the last 2 months,
• •4. Severe immunosuppression (e.g. patients with previously known infection with human immunodeficiency virus and a cluster of differentiation 4 (CD4) count below 350 x 109/L, patients on immunosuppressive therapy after solid organ transplantation and neutropenic patients with neutrophil count \< 500 x 109/L and patients under chemotherapy with neutrophils 500-1000 x 109/L with an expected decrease to values \< 500 x 109/L),
• •5. Hematologic disease (leukocyte count \< 1.5 x 109/l, hemoglobin \< 11 g/dl, platelets \<100 x 103/µl),
• •6. Other clinically significant concomitant disease states (e.g., renal failure \[Creatinine-Clearance \< 30 ml/min\], hepatic dysfunction \[transaminases \>3x upper normal range\], active carcinoma,
• •7. History of tuberculosis,
• •8. Known or suspected non-compliance, drug or alcohol abuse,
• •9. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to anakinra/Kineret®,
• •10. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• •11. Previous enrolment into the current study.