PMID- 21386088
OWN - NLM
STAT- MEDLINE
DCOM- 20110715
LR  - 20220409
IS  - 1935-5548 (Electronic)
IS  - 0149-5992 (Print)
IS  - 0149-5992 (Linking)
VI  - 34
IP  - 4
DP  - 2011 Apr
TI  - Testosterone replacement in hypogonadal men with type 2 diabetes and/or metabolic 
      syndrome (the TIMES2 study).
PG  - 828-37
LID - 10.2337/dc10-1233 [doi]
AB  - 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.
FAU - Jones, T Hugh
AU  - Jones TH
AD  - The Robert Hague Centre for Diabetes and Endocrinology, Barnsley Hospital, 
      Barnsley, UK. hugh.jones@nhs.net
FAU - Arver, Stefan
AU  - Arver S
FAU - Behre, Hermann M
AU  - Behre HM
FAU - Buvat, Jacques
AU  - Buvat J
FAU - Meuleman, Eric
AU  - Meuleman E
FAU - Moncada, Ignacio
AU  - Moncada I
FAU - Morales, Antonio Martin
AU  - Morales AM
FAU - Volterrani, Maurizio
AU  - Volterrani M
FAU - Yellowlees, Ann
AU  - Yellowlees A
FAU - Howell, Julian D
AU  - Howell JD
FAU - Channer, Kevin S
AU  - Channer KS
CN  - TIMES2 Investigators
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110308
PL  - United States
TA  - Diabetes Care
JT  - Diabetes care
JID - 7805975
RN  - 3XMK78S47O (Testosterone)
SB  - IM
CIN - Diabetes Care. 2011 Nov;34(11):e172; author's reply e173. PMID: 22025791
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Body Composition/drug effects
MH  - Diabetes Mellitus, Type 2/pathology/*physiopathology
MH  - Humans
MH  - Hypogonadism/*drug therapy
MH  - Insulin Resistance
MH  - Male
MH  - Metabolic Syndrome/pathology/*physiopathology
MH  - Middle Aged
MH  - Testosterone/*adverse effects/*therapeutic use
PMC - PMC3064036
EDAT- 2011/03/10 06:00
MHDA- 2011/07/16 06:00
PMCR- 2012/04/01
CRDT- 2011/03/10 06:00
PHST- 2011/03/10 06:00 [entrez]
PHST- 2011/03/10 06:00 [pubmed]
PHST- 2011/07/16 06:00 [medline]
PHST- 2012/04/01 00:00 [pmc-release]
AID - dc10-1233 [pii]
AID - 1233 [pii]
AID - 10.2337/dc10-1233 [doi]
PST - ppublish
SO  - Diabetes Care. 2011 Apr;34(4):828-37. doi: 10.2337/dc10-1233. Epub 2011 Mar 8.