EFFECTS OF TESTOSTERONE SUPPLEMENTATION ON MARKERS OF THE METABOLIC SYNDROME AND INFLAMMATION IN HYPOGONADAL MEN WITH THE METABOLIC SYNDROME: THE DOUBLE-BLIND PLACEBO-CONTROLLED MOSCOW STUDY.

Author(s): Kalinchenko SY, Tishova YA, Mskhalaya GJ, Gooren LJ, Giltay EJ, Saad F

Affiliation(s): . Chair of Endocrinology, The Faculty of Medical Staff Refresher Training, People's Friendship University of Russia, Moscow, Russia.

Publication date & source: 2010-08-13, Clin Endocrinol (Oxf)., [Epub ahead of print]

ABSTRACT Objective: Men with the metabolic syndrome (MetS) have low plasma testosterone (T) levels. The aim of this study was to establish whether normalization of plasma T improves features of the MetS. Design: A randomized, placebo-controlled, double-blind, phase III trial of 184 men suffering from both the MetS and hypogonadism. Patients: 184 men, 35 to 70 years, with the MetS and hypogonadism (baseline total T level <12.0 nmol/l or calculated free T level < 225 pmol/l.), recruited in the outpatient andrology & urology clinic, Research Center for Endocrinology in Moscow, Russia Intervention: Treatment for 30 weeks with either parenteral T undecanoate (n=113; TU; 1000 mg IM) or placebo (n=71), administered at baseline, and after 6 and 18 weeks. 105 (92.9%) men receiving TU and 65 (91.5%) receiving placebo completed the trial. Measurements: Body weight, body mass index (BMI), waist circumference (WC), hip circumference (HC), waist-to-hip ratio (WHR), insulin, leptin, glucose, cholesterol, triglycerides, high density lipoprotein cholesterol (HDL), low density lipoprotein cholesterol (LDL), C-reactive protein (CRP), interleukin-1-beta (IL-1-beta), interleukin-6 (IL-6), interleukin-10 (IL-10), tumour necrosis factor-alpha (TNF-alpha). Results: There were significant decreases in weight, BMI and WC in the TU versus placebo group. Levels of leptin and insulin also decreased, but there were no changes in serum glucose or lipid profile. Of the inflammatory markers, IL-1-beta, TNF-alpha, and CRP decreased, while IL -6 and IL-10 did not change significantly. Conclusions: 30 weeks of T administration normalizing plasma T in hypogonadal men with the MetS improved some components of the MetS and a number of inflammatory markers.