Effects of testosterone supplementation on markers of the metabolic syndrome and inflammation in hypogonadal men with the metabolic syndrome: The double-blinded placebo-controlled Moscow study

Objective- Men with the metabolic syndrome (MetS) have low plasma testosterone (T) levels. The aim of this study was to establish whether the normalization of plasma T improves the features of the MetS. Design- A randomized, placebo-controlled, double-blinded, phase III trial of 184 men suffering from both the MetS and hypogonadism. Patients- One hundred and eighty-four men, aged 35-70, with the MetS and hypogonadism (baseline total T level <12•0 nm or calculated free T level <225 pm.), recruited in the outpatient andrology and 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. One hundred and five (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, waist-to-hip ratio, insulin, leptin, glucose, cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, C-reactive protein (CRP), interleukin-1-beta (IL-1β), interleukin-6 (IL-6), interleukin-10 (IL-10) and tumour necrosis factor-alpha (TNF-α). Results- There were significant decreases in weight, BMI and WC in the TU vs 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-1β, TNF-α and CRP decreased, while IL-6 and IL-10 did not change significantly. Conclusions- Thirty 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. © 2010 Blackwell Publishing Ltd.

Номер выпуска
  • 1 Department of Endocrinology, Faculty of Medical Staff Refresher Training, People's Friendship University of Russia, Pokrovka, 22/1, Moscow 125080, Russian Federation
  • 2 Medical Clinic of Reproduction MAMA, Moscow, Russian Federation
  • 3 Department of Endocrinology, VU University Medical Center, Amsterdam, Netherlands
  • 4 Department of Psychiatry, Leiden University Medical Center, Leiden, Netherlands
  • 5 Bayer Schering Pharma, Scientific Affairs Men's Healthcare, Berlin, Germany
  • 6 Gulf Medical University School of Medicine, Ajman, United Arab Emirates
Ключевые слова
bilirubin; biochemical marker; C reactive protein; estradiol; hemoglobin; high density lipoprotein cholesterol; insulin; interleukin 10; interleukin 1beta; interleukin 6; leptin; low density lipoprotein cholesterol; luteinizing hormone; placebo; prostate specific antigen; sex hormone binding globulin; testosterone; testosterone undecanoate; triacylglycerol; tumor necrosis factor alpha; adult; aged; androgen therapy; article; bilirubin blood level; body mass; body weight; clinical trial; controlled clinical trial; controlled study; double blind procedure; drug efficacy; drug safety; glucose blood level; hematocrit; hematopoiesis; hormone blood level; human; hypogonadism; inflammation; insulin blood level; lipid blood level; major clinical study; male; metabolic syndrome X; phase 3 clinical trial; priority journal; prostate; randomized controlled trial; Russian Federation; testosterone blood level; waist circumference; waist hip ratio; Adult; Aged; Body Mass Index; C-Reactive Protein; Humans; Hypogonadism; Inflammation; Insulin; Interleukin-10; Interleukin-6; Leptin; Lipids; Male; Metabolic Syndrome X; Middle Aged; Testosterone; Tumor Necrosis Factor-alpha; Waist Circumference; Waist-Hip Ratio
Дата создания
Дата изменения
Постоянная ссылка

Другие записи