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FRI434 Long-term Self-reported Outcomes Of Randomized Testosterone (T) vs Placebo (P) Treatment In The T4DM Study

Disclosure: D.J. Handelsman: None. M. Grossmann: None. B.B. Yeap: Consulting Fee; Self; Bayer, Inc., Lawley. Research Investigator; Self; Lawley. B.G. Stuckey: Speaker; Self; Lawley. N. Shankara-Narayana: None. A.J. Conway: None. W. Inder: None. R.I. McLachlan: None. C.A. Allan: None. A. Jenkins: No...

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Autores principales: Handelsman, David J, Grossmann, Mathis, Yeap, Bu Beng, Stuckey, Bronwyn G A, Shankara-Narayana, Nandini, Conway, Ann J, Inder, Warrick, McLachlan, Robert I, Allan, Carolyn A, Jenkins, Alicia, Jesudason, David R, Bracken, Karen, Robledo, Kristy, Wittert, Gary A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10554783/
http://dx.doi.org/10.1210/jendso/bvad114.1625
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author Handelsman, David J
Grossmann, Mathis
Yeap, Bu Beng
Stuckey, Bronwyn G A
Shankara-Narayana, Nandini
Conway, Ann J
Inder, Warrick
McLachlan, Robert I
Allan, Carolyn A
Jenkins, Alicia
Jesudason, David R
Bracken, Karen
Robledo, Kristy
Wittert, Gary A
author_facet Handelsman, David J
Grossmann, Mathis
Yeap, Bu Beng
Stuckey, Bronwyn G A
Shankara-Narayana, Nandini
Conway, Ann J
Inder, Warrick
McLachlan, Robert I
Allan, Carolyn A
Jenkins, Alicia
Jesudason, David R
Bracken, Karen
Robledo, Kristy
Wittert, Gary A
author_sort Handelsman, David J
collection PubMed
description Disclosure: D.J. Handelsman: None. M. Grossmann: None. B.B. Yeap: Consulting Fee; Self; Bayer, Inc., Lawley. Research Investigator; Self; Lawley. B.G. Stuckey: Speaker; Self; Lawley. N. Shankara-Narayana: None. A.J. Conway: None. W. Inder: None. R.I. McLachlan: None. C.A. Allan: None. A. Jenkins: None. D.R. Jesudason: None. K. Bracken: None. K. Robledo: None. G.A. Wittert: Research Investigator; Self; Bayer, Inc., Lilly USA, LLC. The T4DM study randomized 1007 men (age 50-74 yr, waist ≥95 cm, serum T ≤14.0 nmol/L, no pathological hypogonadism) with impaired glucose tolerance or newly diagnosed type 2 diabetes to T undecanoate (1000 mg) or matching placebo injections every 12 weeks for 24 months with a lifestyle program. At study’s end, T treatment reduced OGTT diabetes diagnosis by 40% without change in HbA(1)C. After a median of 5 years since last injection, a follow-up email survey obtained 705 responses (70%) comprising 599 completed surveys (316 T, 283 P, 10 deceased, 95 declining). Participants in follow-up survey were similar to non-participants in 23 anthropometric and demographic variables at entry to T4DM, but more in follow-up study were randomized to T (53 vs 46%%, p=0.038), had lower entry weight (107 vs 109 kg, p=0.026) and older school leaving age (16.7 vs 16.5 years, p=0.026) but remaining well matched for work status (46% retired, 35% full-time work, p=0.60), alcohol intake (69% nil or light, 3% heavy; p=0.12) and smoking (3% smoking, p=0.61). At long-term follow-up, randomization to T treatment was associated with stronger belief in benefits during study (64% vs 49%, p<0.001) with less for post-study benefits (44% vs 40%, p=0.07) but overall high interest in future studies (surveys 93%, clinical 76%). At entry, 35% had sleep apnea, most (71%) diagnosed pre-study, with new diagnosis more frequent on T during (9% vs 1%, p=0.03), but not before or after, the study. After study, T treatment was prescribed at a higher rate for men who had study T treatment (6% vs 2.8%, p=0.03), mostly using T injections with 81% continuing at 24 months (median) on post-study T treatment. In the long-term, study T treatment did not influence self-reported new post-T4DM study diagnosis of diabetes (19%, p=0.65) or diabetes drug treatments (22%, p=0.31; oral 18%, injectable 2%, both 2%), prostate disease (p=0.49; cancer 3%, non-cancer 8%) or cardiovascular disease (p=0.95; heart disease 13%, stroke 1%). Both groups had similar weight maintenance (maintained 24%, lost 22%, gain 24%, up/down 30%, p=0.91) and further attempts to lose weight (76%, p=0.29; diet 68%, exercise 57%, drugs 6%, surgery 2%). We conclude that randomized T (vs placebo) treatment for 24 months in men with impaired glucose tolerance or new diabetes but without pathological hypogonadism, was associated with higher rates of (a) self-reported benefits during, but not after the study, (b) of resuming T treatment after the study, consistent with androgen dependence due to withdrawal (androgen deficiency) symptoms and/or recalling perceived benefits of study T treatment, and (c) of sleep apnea diagnosis during, but not before or after the study. Five years after T treatment stopped, there was no difference in the long-term rates of self-reported new diagnosis of diabetes, prostate or cardiovascular disease nor change in weight maintenance or weight loss behaviors. Presentation: Friday, June 16, 2023
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spelling pubmed-105547832023-10-06 FRI434 Long-term Self-reported Outcomes Of Randomized Testosterone (T) vs Placebo (P) Treatment In The T4DM Study Handelsman, David J Grossmann, Mathis Yeap, Bu Beng Stuckey, Bronwyn G A Shankara-Narayana, Nandini Conway, Ann J Inder, Warrick McLachlan, Robert I Allan, Carolyn A Jenkins, Alicia Jesudason, David R Bracken, Karen Robledo, Kristy Wittert, Gary A J Endocr Soc Reproductive Endocrinology Disclosure: D.J. Handelsman: None. M. Grossmann: None. B.B. Yeap: Consulting Fee; Self; Bayer, Inc., Lawley. Research Investigator; Self; Lawley. B.G. Stuckey: Speaker; Self; Lawley. N. Shankara-Narayana: None. A.J. Conway: None. W. Inder: None. R.I. McLachlan: None. C.A. Allan: None. A. Jenkins: None. D.R. Jesudason: None. K. Bracken: None. K. Robledo: None. G.A. Wittert: Research Investigator; Self; Bayer, Inc., Lilly USA, LLC. The T4DM study randomized 1007 men (age 50-74 yr, waist ≥95 cm, serum T ≤14.0 nmol/L, no pathological hypogonadism) with impaired glucose tolerance or newly diagnosed type 2 diabetes to T undecanoate (1000 mg) or matching placebo injections every 12 weeks for 24 months with a lifestyle program. At study’s end, T treatment reduced OGTT diabetes diagnosis by 40% without change in HbA(1)C. After a median of 5 years since last injection, a follow-up email survey obtained 705 responses (70%) comprising 599 completed surveys (316 T, 283 P, 10 deceased, 95 declining). Participants in follow-up survey were similar to non-participants in 23 anthropometric and demographic variables at entry to T4DM, but more in follow-up study were randomized to T (53 vs 46%%, p=0.038), had lower entry weight (107 vs 109 kg, p=0.026) and older school leaving age (16.7 vs 16.5 years, p=0.026) but remaining well matched for work status (46% retired, 35% full-time work, p=0.60), alcohol intake (69% nil or light, 3% heavy; p=0.12) and smoking (3% smoking, p=0.61). At long-term follow-up, randomization to T treatment was associated with stronger belief in benefits during study (64% vs 49%, p<0.001) with less for post-study benefits (44% vs 40%, p=0.07) but overall high interest in future studies (surveys 93%, clinical 76%). At entry, 35% had sleep apnea, most (71%) diagnosed pre-study, with new diagnosis more frequent on T during (9% vs 1%, p=0.03), but not before or after, the study. After study, T treatment was prescribed at a higher rate for men who had study T treatment (6% vs 2.8%, p=0.03), mostly using T injections with 81% continuing at 24 months (median) on post-study T treatment. In the long-term, study T treatment did not influence self-reported new post-T4DM study diagnosis of diabetes (19%, p=0.65) or diabetes drug treatments (22%, p=0.31; oral 18%, injectable 2%, both 2%), prostate disease (p=0.49; cancer 3%, non-cancer 8%) or cardiovascular disease (p=0.95; heart disease 13%, stroke 1%). Both groups had similar weight maintenance (maintained 24%, lost 22%, gain 24%, up/down 30%, p=0.91) and further attempts to lose weight (76%, p=0.29; diet 68%, exercise 57%, drugs 6%, surgery 2%). We conclude that randomized T (vs placebo) treatment for 24 months in men with impaired glucose tolerance or new diabetes but without pathological hypogonadism, was associated with higher rates of (a) self-reported benefits during, but not after the study, (b) of resuming T treatment after the study, consistent with androgen dependence due to withdrawal (androgen deficiency) symptoms and/or recalling perceived benefits of study T treatment, and (c) of sleep apnea diagnosis during, but not before or after the study. Five years after T treatment stopped, there was no difference in the long-term rates of self-reported new diagnosis of diabetes, prostate or cardiovascular disease nor change in weight maintenance or weight loss behaviors. Presentation: Friday, June 16, 2023 Oxford University Press 2023-10-05 /pmc/articles/PMC10554783/ http://dx.doi.org/10.1210/jendso/bvad114.1625 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Reproductive Endocrinology
Handelsman, David J
Grossmann, Mathis
Yeap, Bu Beng
Stuckey, Bronwyn G A
Shankara-Narayana, Nandini
Conway, Ann J
Inder, Warrick
McLachlan, Robert I
Allan, Carolyn A
Jenkins, Alicia
Jesudason, David R
Bracken, Karen
Robledo, Kristy
Wittert, Gary A
FRI434 Long-term Self-reported Outcomes Of Randomized Testosterone (T) vs Placebo (P) Treatment In The T4DM Study
title FRI434 Long-term Self-reported Outcomes Of Randomized Testosterone (T) vs Placebo (P) Treatment In The T4DM Study
title_full FRI434 Long-term Self-reported Outcomes Of Randomized Testosterone (T) vs Placebo (P) Treatment In The T4DM Study
title_fullStr FRI434 Long-term Self-reported Outcomes Of Randomized Testosterone (T) vs Placebo (P) Treatment In The T4DM Study
title_full_unstemmed FRI434 Long-term Self-reported Outcomes Of Randomized Testosterone (T) vs Placebo (P) Treatment In The T4DM Study
title_short FRI434 Long-term Self-reported Outcomes Of Randomized Testosterone (T) vs Placebo (P) Treatment In The T4DM Study
title_sort fri434 long-term self-reported outcomes of randomized testosterone (t) vs placebo (p) treatment in the t4dm study
topic Reproductive Endocrinology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10554783/
http://dx.doi.org/10.1210/jendso/bvad114.1625
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