OBJECTIVE: The objective of the study was to assess the effect of T treatment on constitutional and sexual symptoms in men with type 2 diabetes (T2D). DESIGN: This was a randomized double-blind, parallel, placebo-controlled trial. SETTING: The study was conducted at a tertiary referral center. PATIENTS: Men aged 35-70 years with T2D, a hemoglobin A1c less than 8.5%, and a total T level less than 12.0 nmol/L (346 ng/dL) with mild to moderate aging male symptoms and erectile dysfunction. INTERVENTION: Eighty-eight participants were randomly assigned to 40 weeks of im T undecanoate (n = 45) or matching placebo (n = 43). MAIN OUTCOME MEASURES: Constitutional symptoms using the aging male symptoms (AMS) score, sexual desire (question 17 AMS score), and erectile function (International Index of Erectile Function-5). RESULTS:T treatment did not substantially improve aging male symptoms [mean adjusted difference (MAD) in change over 40 weeks across the T and placebo groups in AMS total score, -0.9 (95% confidence interval [CI] -4.1, 2.2), P = .67] or sexual desire [MAD in question 17 AMS, -0.3 (95% CI -0.8, 0.2), P = .17]. Although compared with placebo, erectile function in men assigned to T was reduced [MAD in International Index of Erectile Function abridged version 5, -2.0 (95% CI -3.4, -0.6), P < .02], there was no significant difference between baseline and 40-week International Index of Erectile Function abridged version 5 scores if both groups were analyzed separately. At baseline, symptoms were worse in men with depression and microvascular complications but did not correlate with T levels. CONCLUSIONS: In this trial, T treatment did not substantially improve constitutional or sexual symptoms in obese, aging men with T2D with mild to moderate symptoms and modest reduction in T levels typical for the vast majority of such men.
RCT Entities:
OBJECTIVE: The objective of the study was to assess the effect of T treatment on constitutional and sexual symptoms in men with type 2 diabetes (T2D). DESIGN: This was a randomized double-blind, parallel, placebo-controlled trial. SETTING: The study was conducted at a tertiary referral center. PATIENTS: Men aged 35-70 years with T2D, a hemoglobin A1c less than 8.5%, and a total T level less than 12.0 nmol/L (346 ng/dL) with mild to moderate aging male symptoms and erectile dysfunction. INTERVENTION: Eighty-eight participants were randomly assigned to 40 weeks of im T undecanoate (n = 45) or matching placebo (n = 43). MAIN OUTCOME MEASURES: Constitutional symptoms using the aging male symptoms (AMS) score, sexual desire (question 17 AMS score), and erectile function (International Index of Erectile Function-5). RESULTS: T treatment did not substantially improve aging male symptoms [mean adjusted difference (MAD) in change over 40 weeks across the T and placebo groups in AMS total score, -0.9 (95% confidence interval [CI] -4.1, 2.2), P = .67] or sexual desire [MAD in question 17 AMS, -0.3 (95% CI -0.8, 0.2), P = .17]. Although compared with placebo, erectile function in men assigned to T was reduced [MAD in International Index of Erectile Function abridged version 5, -2.0 (95% CI -3.4, -0.6), P < .02], there was no significant difference between baseline and 40-week International Index of Erectile Function abridged version 5 scores if both groups were analyzed separately. At baseline, symptoms were worse in men with depression and microvascular complications but did not correlate with T levels. CONCLUSIONS: In this trial, T treatment did not substantially improve constitutional or sexual symptoms in obese, aging men with T2D with mild to moderate symptoms and modest reduction in T levels typical for the vast majority of such men.
Authors: Jemma Hudson; Moira Cruickshank; Richard Quinton; Lorna Aucott; Magaly Aceves-Martins; Katie Gillies; Shalender Bhasin; Peter J Snyder; Susan S Ellenberg; Mathis Grossmann; Thomas G Travison; Emily J Gianatti; Yvonne T van der Schouw; Marielle H Emmelot-Vonk; Erik J Giltay; Geoff Hackett; Sudarshan Ramachandran; Johan Svartberg; Kerry L Hildreth; Kristina Groti Antonic; Gerald B Brock; J Lisa Tenover; Hui Meng Tan; Christopher Ho Chee Kong; Wei Shen Tan; Leonard S Marks; Richard J Ross; Robert S Schwartz; Paul Manson; Stephen Roberts; Marianne Skovsager Andersen; Line Velling Magnussen; Rodolfo Hernández; Nick Oliver; Frederick Wu; Waljit S Dhillo; Siladitya Bhattacharya; Miriam Brazzelli; Channa N Jayasena Journal: Lancet Healthy Longev Date: 2022-06
Authors: Samantha Huo; Anthony R Scialli; Sean McGarvey; Elizabeth Hill; Buğra Tügertimur; Alycia Hogenmiller; Alessandra I Hirsch; Adriane Fugh-Berman Journal: PLoS One Date: 2016-09-21 Impact factor: 3.240