Back to Search
Start Over
Testosterone replacement in hypogonadal men with type 2 diabetes and/or metabolic syndrome (the TIMES2 study).
- Source :
-
Diabetes care [Diabetes Care] 2011 Apr; Vol. 34 (4), pp. 828-37. Date of Electronic Publication: 2011 Mar 08. - Publication Year :
- 2011
-
Abstract
- 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).<br />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).<br />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.<br />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.
- Subjects :
- Adult
Aged
Aged, 80 and over
Body Composition drug effects
Diabetes Mellitus, Type 2 pathology
Humans
Insulin Resistance
Male
Metabolic Syndrome pathology
Middle Aged
Diabetes Mellitus, Type 2 physiopathology
Hypogonadism drug therapy
Metabolic Syndrome physiopathology
Testosterone adverse effects
Testosterone therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1935-5548
- Volume :
- 34
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Diabetes care
- Publication Type :
- Academic Journal
- Accession number :
- 21386088
- Full Text :
- https://doi.org/10.2337/dc10-1233