Testosterone Replacement in Hypogonadal Men With Type 2 Diabetes and/or Metabolic Syndrome (the TIMES2 Study)

被引:444
作者
Jones, T. Hugh [1 ,2 ]
Arver, Stefan [3 ,4 ]
Behre, Hermann M. [5 ]
Buvat, Jacques [6 ]
Meuleman, Eric [7 ]
Moncada, Ignacio [8 ]
Morales, Antonio Martin [9 ]
Volterrani, Maurizio [10 ]
Yellowlees, Ann
Howell, Julian D. [11 ]
Channer, Kevin S. [12 ]
机构
[1] Barnsley Hosp, Robert Hague Ctr Diabet & Endocrinol, Barnsley, England
[2] Univ Sheffield, Sch Med & Biomed Sci, Dept Human Metab, Sheffield, S Yorkshire, England
[3] Karolinska Univ Hosp, Ctr Androl & Sexual Med, Stockholm, Sweden
[4] Karolinska Inst, Stockholm, Sweden
[5] Univ Halle Wittenberg, Univ Hosp Halle Saale, Ctr Reprod Med & Androl, Halle, Germany
[6] CETPARP, Lille, France
[7] Vrije Univ Amsterdam Med Ctr, Dept Urol, Amsterdam, Netherlands
[8] Hosp Sanitas La Zarzuela, Dept Urol, Madrid, Spain
[9] Carlos Haya Univ Hosp, Dept Urol, Malaga, Spain
[10] Ist Ricovero & Cura Carattere Sci IRCCS San Raffa, Dept Cardiol, Rome, Italy
[11] ProStrakan, Dept Clin Res, Galashiels, Scotland
[12] Royal Hallamshire Hosp, Dept Cardiol, Sheffield S10 2JF, S Yorkshire, England
关键词
ANDROGEN DEPRIVATION THERAPY; CARDIOVASCULAR-DISEASE; ERECTILE DYSFUNCTION; INSULIN SENSITIVITY; VISCERAL ADIPOSITY; GLYCEMIC CONTROL; POPULATION; RESISTANCE; RISK;
D O I
10.2337/dc10-1233
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVE-This study evaluated the effects of testosterone replacement therapy (TRT) on insulin resistance, cardiovascular risk factors, and symptoms in hypogonadal men with type 2 diabetes and/or metabolic syndrome (MetS). RESEARCH DESIGN AND METHODS-The efficacy, safety, and tolerability of a novel transdermal 2% testosterone gel was evaluated over 12 months in 220 hypogonadal men with type 2 diabetes and/or MetS in a multicenter, prospective, randomized, double-blind, placebo-controlled study. The primary outcome was mean change from baseline in homeostasis model assessment of insulin resistance (HOMA-IR). Secondary outcomes were measures of body composition, glycemic control, lipids, and sexual function. Efficacy results focused primarily on months 0-6 (phase 1; no changes in medication allowed). Medication changes were allowed in phase 2 (months 6-12). RESULTS-TRT reduced HOMA-IR in the overall population by 15.2% at 6 months (P = 0.018) and 16.4% at 12 months (P = 0.006). In type 2 diabetic patients, glycemic control was significantly better in the TRT group than the placebo group at month 9 (HbA(1c): treatment difference, -0.446%; P = 0.035). Improvements in total and LDL cholesterol, lipoprotein a (Lpa), body composition, libido, and sexual function occurred in selected patient groups. There were no significant differences between groups in the frequencies of adverse events (AEs) or serious AEs. The majority of AEs (>95%) were mild or moderate. CONCLUSIONS-Over a 6-month period, transdermal TRT was associated with beneficial effects on insulin resistance, total and LDL-cholesterol, Lpa, and sexual health in hypogonadal men with type 2 diabetes and/or MetS. Diabetes Care 34:828-837, 2011
引用
收藏
页码:828 / 837
页数:10
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