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

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 no...

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Autores principales: Jones, T. Hugh, Arver, Stefan, Behre, Hermann M., Buvat, Jacques, Meuleman, Eric, Moncada, Ignacio, Morales, Antonio Martin, Volterrani, Maurizio, Yellowlees, Ann, Howell, Julian D., Channer, Kevin S.
Formato: Texto
Lenguaje:English
Publicado: American Diabetes Association 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3064036/
https://www.ncbi.nlm.nih.gov/pubmed/21386088
http://dx.doi.org/10.2337/dc10-1233
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author Jones, T. Hugh
Arver, Stefan
Behre, Hermann M.
Buvat, Jacques
Meuleman, Eric
Moncada, Ignacio
Morales, Antonio Martin
Volterrani, Maurizio
Yellowlees, Ann
Howell, Julian D.
Channer, Kevin S.
author_facet Jones, T. Hugh
Arver, Stefan
Behre, Hermann M.
Buvat, Jacques
Meuleman, Eric
Moncada, Ignacio
Morales, Antonio Martin
Volterrani, Maurizio
Yellowlees, Ann
Howell, Julian D.
Channer, Kevin S.
author_sort Jones, T. Hugh
collection PubMed
description 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.
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spelling pubmed-30640362012-04-01 Testosterone Replacement in Hypogonadal Men With Type 2 Diabetes and/or Metabolic Syndrome (the TIMES2 Study) Jones, T. Hugh Arver, Stefan Behre, Hermann M. Buvat, Jacques Meuleman, Eric Moncada, Ignacio Morales, Antonio Martin Volterrani, Maurizio Yellowlees, Ann Howell, Julian D. Channer, Kevin S. Diabetes Care Original Research 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. American Diabetes Association 2011-04 2011-03-21 /pmc/articles/PMC3064036/ /pubmed/21386088 http://dx.doi.org/10.2337/dc10-1233 Text en © 2011 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.
spellingShingle Original Research
Jones, T. Hugh
Arver, Stefan
Behre, Hermann M.
Buvat, Jacques
Meuleman, Eric
Moncada, Ignacio
Morales, Antonio Martin
Volterrani, Maurizio
Yellowlees, Ann
Howell, Julian D.
Channer, Kevin S.
Testosterone Replacement in Hypogonadal Men With Type 2 Diabetes and/or Metabolic Syndrome (the TIMES2 Study)
title Testosterone Replacement in Hypogonadal Men With Type 2 Diabetes and/or Metabolic Syndrome (the TIMES2 Study)
title_full Testosterone Replacement in Hypogonadal Men With Type 2 Diabetes and/or Metabolic Syndrome (the TIMES2 Study)
title_fullStr Testosterone Replacement in Hypogonadal Men With Type 2 Diabetes and/or Metabolic Syndrome (the TIMES2 Study)
title_full_unstemmed Testosterone Replacement in Hypogonadal Men With Type 2 Diabetes and/or Metabolic Syndrome (the TIMES2 Study)
title_short Testosterone Replacement in Hypogonadal Men With Type 2 Diabetes and/or Metabolic Syndrome (the TIMES2 Study)
title_sort testosterone replacement in hypogonadal men with type 2 diabetes and/or metabolic syndrome (the times2 study)
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3064036/
https://www.ncbi.nlm.nih.gov/pubmed/21386088
http://dx.doi.org/10.2337/dc10-1233
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