RT Journal Article
T1 Metformin, testosterone, or both in men with obesity and low testosterone: A double-blind, parallel-group, randomized controlled trial.
A1 Fernandez-Garcia, Jose Carlos
A1 Barrios-Rodriguez, Rocio
A1 Asenjo-Plaza, Maite
A1 Ramos-Molina, Bruno
A1 Molina-Vega, Maria
A1 Guzman-Guzman, Antonio
A1 Moreno-Leon, Luis
A1 Yubero-Serrano, Elena M
A1 Rius-Diaz, Francisca
A1 Valdes, Sergio
A1 Martinez-Gonzalez, Miguel Angel
A1 Jimenez-Moleon, Jose Juan
A1 Tinahones, Francisco J
K1 Erectile dysfunction
K1 Insulin resistance
K1 Metformin
K1 Obesity
K1 Testosterone
AB Men with obesity tend to be insulin resistant and often have low-normal testosterone concentrations. We conducted a clinical trial aimed to evaluate potential therapeutic strategies for low testosterone in men with obesity. We did a 1-year, parallel, randomized, double-blind, placebo-controlled trial, where we evaluated the independent and combined effects of metformin and testosterone in 106 men with obesity, aged 18-50 years, who had low levels of testosterone and no diabetes mellitus. The primary outcome was change in insulin resistance, measured as Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index. Secondary outcomes included changes in total and free serum testosterone, body composition, metabolic variables, erectile function, and health-related quality of life (HRQoL). In the intention-to-treat analysis, the HOMA-IR index decreased significantly in all active groups compared to placebo (metformin -2.4, 95 % CI -4.1 to -0.8, p = 0.004; testosterone -2.7, 95 % CI -4.3 to -1.1, p = 0.001; combination -3.4, 95 % CI -5.0 to -1.8, p  Among men with obesity and low testosterone concentrations, the combination of metformin plus testosterone, metformin only, and testosterone only, compared to placebo, reduced insulin resistance with no evidence of additive benefit.
PB Elsevier
YR 2022
FD 2022-08-11
LK http://hdl.handle.net/10668/22390
UL http://hdl.handle.net/10668/22390
LA en
NO Fernández-García JC, Barrios-Rodríguez R, Asenjo-Plaza M, Ramos-Molina B, Molina-Vega M, Guzmán-Guzmán A, et al. Metformin, testosterone, or both in men with obesity and low testosterone: A double-blind, parallel-group, randomized controlled trial. Metabolism. 2022 Nov;136:155290
NO The authors wish to thank all the study participants for their collaboration and Maria Repice for English language editing of this article. Also, the authors thank Bayer Pharma AG for the donation of testosterone undecanoate and matching placebo. JCFG was supported by a research contract from the Servicio Andaluz de Salud, Spain (SAS; B0003-2017) and by an intensification research program (INT21/00078, Instituto de Salud Carlos III, Spain; co-funded by the Fondo Europeo de Desarrollo Regional-FEDER); BRM was supported by the Miguel Servet Type I program (CP19/00098, Instituto de Salud Carlos III, Spain; cofunded by the Fondo Europeo de Desarrollo Regional-FEDER); MMV was supported by a Rio Hortega grant from the Instituto de Salud Carlos III, Spain (CM18/00120); EMYS was the recipient of the Nicolas Monardes Programme from the Servicio Andaluz de Salud, Junta de Andalucia, Spain (C1-0005-2019). This work was supported by a grant from Servicio Andaluz de Salud (PI-0173-2013). The funding organization played no role in the design and performance of the study, choice of enrolled subjects, review and interpretation of the data, or final approval of the manuscript.
DS RISalud
RD Apr 7, 2025