Metformin, testosterone, or both in men with obesity and low testosterone: a double-blind, parallel-group, randomized controlled trial
Background: 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. Methods: We did a 1-year, parallel, randomized, double-blind, pl...
| Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | article |
| Publication Date: | 2022 |
| Country: | España |
| Institution: | Universidad de Navarra |
| Repository: | Dadun. Depósito Académico Digital de la Universidad de Navarra |
| Language: | English |
| OAI Identifier: | oai:dnet:dadun_______::4fa5168c6586b6805853f54c10f85645 |
| Online Access: | https://hdl.handle.net/10171/124546 |
| Access Level: | Open access |
| Keyword: | Erectile dysfunction Insulin resistance Metformin Obesity Testosterone |
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Metformin, testosterone, or both in men with obesity and low testosterone: a double-blind, parallel-group, randomized controlled trialFernández-García, J.C. (José Carlos)|||/items/88c911df-a83d-4be9-aca5-d298ee41f6cbBarrios-Rodríguez, R. (Rocío)|||/items/a1817321-37c7-402b-b7bc-70d1464f3addAsenjo-Plaza, M. (Maite)|||/items/70f1d7d2-fb4e-441d-aff2-2b490ee6ee25Ramos-Molina, B. (Bruno)|||/items/728f7858-ad11-4f2a-b259-7dd369f72220Molina-Vega, M. (María)|||/items/00d2b443-7ffa-4abb-a997-a8fc772af24aPeinado-Guzmán, J. A. (José Antonio)|||/items/74ec3b93-c3d5-47d6-b8f0-95d9b528f48fMoreno-León, L. (Luis)|||/items/af529412-6d1b-47b7-956f-cd6fd200753aYubero-Serrano, E.M. (Elena M.)|||/items/133e700d-159b-4eb8-ac7e-f3de8668645cRius-Díaz, F. (Francisca)|||/items/b9312d2e-c945-417f-9d12-7a92b856b47bValdes, S. (Sergio)|||/items/018ae2cf-0a02-4601-bc06-8b62452b3319Martínez-González, M.A. (Miguel Ángel)|||/items/8b591471-4165-4697-8534-cfa0ad5eb1b7Jiménez-Moleón, J.J. (José Juan)|||/items/cb714f5d-4da0-4452-8033-a194006facecTinahones, F.J. (Francisco J.)|||/items/3c469348-deec-4066-bd93-383e05813c10Erectile dysfunctionInsulin resistanceMetforminObesityTestosteroneBackground: 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. Methods: 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). Results: 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 < 0.001). Combination therapy was not superior to testosterone alone in decreasing insulin resistance (-0.7, 95 % CI -2.3 to 0.9, p = 0.383). Only the combination of metformin plus testosterone significantly increased total and free testosterone concentrations, compared to placebo. No significant changes in body composition (except for a higher decrease in fat mass in the metformin and combination group), metabolic variables, erectile function, or HRQoL were found with any treatment. Conclusions: 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.ElsevierDadun. Depósito Académico Digital Universidad de Navarra20222022-01-0120222022-01-01journal articlehttp://purl.org/coar/resource_type/c_6501info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/10171/124546reponame:Dadun. Depósito Académico Digital de la Universidad de Navarrainstname:Universidad de NavarraInglésengopen accesshttp://purl.org/coar/access_right/c_abf2info:eu-repo/semantics/openAccessoai:dnet:dadun_______::4fa5168c6586b6805853f54c10f856452026-06-21T12:47:57Z |
| dc.title.none.fl_str_mv |
Metformin, testosterone, or both in men with obesity and low testosterone: a double-blind, parallel-group, randomized controlled trial |
| title |
Metformin, testosterone, or both in men with obesity and low testosterone: a double-blind, parallel-group, randomized controlled trial |
| spellingShingle |
Metformin, testosterone, or both in men with obesity and low testosterone: a double-blind, parallel-group, randomized controlled trial Fernández-García, J.C. (José Carlos)|||/items/88c911df-a83d-4be9-aca5-d298ee41f6cb Erectile dysfunction Insulin resistance Metformin Obesity Testosterone |
| title_short |
Metformin, testosterone, or both in men with obesity and low testosterone: a double-blind, parallel-group, randomized controlled trial |
| title_full |
Metformin, testosterone, or both in men with obesity and low testosterone: a double-blind, parallel-group, randomized controlled trial |
| title_fullStr |
Metformin, testosterone, or both in men with obesity and low testosterone: a double-blind, parallel-group, randomized controlled trial |
| title_full_unstemmed |
Metformin, testosterone, or both in men with obesity and low testosterone: a double-blind, parallel-group, randomized controlled trial |
| title_sort |
Metformin, testosterone, or both in men with obesity and low testosterone: a double-blind, parallel-group, randomized controlled trial |
| dc.creator.none.fl_str_mv |
Fernández-García, J.C. (José Carlos)|||/items/88c911df-a83d-4be9-aca5-d298ee41f6cb Barrios-Rodríguez, R. (Rocío)|||/items/a1817321-37c7-402b-b7bc-70d1464f3add Asenjo-Plaza, M. (Maite)|||/items/70f1d7d2-fb4e-441d-aff2-2b490ee6ee25 Ramos-Molina, B. (Bruno)|||/items/728f7858-ad11-4f2a-b259-7dd369f72220 Molina-Vega, M. (María)|||/items/00d2b443-7ffa-4abb-a997-a8fc772af24a Peinado-Guzmán, J. A. (José Antonio)|||/items/74ec3b93-c3d5-47d6-b8f0-95d9b528f48f Moreno-León, L. (Luis)|||/items/af529412-6d1b-47b7-956f-cd6fd200753a Yubero-Serrano, E.M. (Elena M.)|||/items/133e700d-159b-4eb8-ac7e-f3de8668645c Rius-Díaz, F. (Francisca)|||/items/b9312d2e-c945-417f-9d12-7a92b856b47b Valdes, S. (Sergio)|||/items/018ae2cf-0a02-4601-bc06-8b62452b3319 Martínez-González, M.A. (Miguel Ángel)|||/items/8b591471-4165-4697-8534-cfa0ad5eb1b7 Jiménez-Moleón, J.J. (José Juan)|||/items/cb714f5d-4da0-4452-8033-a194006facec Tinahones, F.J. (Francisco J.)|||/items/3c469348-deec-4066-bd93-383e05813c10 |
| author |
Fernández-García, J.C. (José Carlos)|||/items/88c911df-a83d-4be9-aca5-d298ee41f6cb |
| author_facet |
Fernández-García, J.C. (José Carlos)|||/items/88c911df-a83d-4be9-aca5-d298ee41f6cb Barrios-Rodríguez, R. (Rocío)|||/items/a1817321-37c7-402b-b7bc-70d1464f3add Asenjo-Plaza, M. (Maite)|||/items/70f1d7d2-fb4e-441d-aff2-2b490ee6ee25 Ramos-Molina, B. (Bruno)|||/items/728f7858-ad11-4f2a-b259-7dd369f72220 Molina-Vega, M. (María)|||/items/00d2b443-7ffa-4abb-a997-a8fc772af24a Peinado-Guzmán, J. A. (José Antonio)|||/items/74ec3b93-c3d5-47d6-b8f0-95d9b528f48f Moreno-León, L. (Luis)|||/items/af529412-6d1b-47b7-956f-cd6fd200753a Yubero-Serrano, E.M. (Elena M.)|||/items/133e700d-159b-4eb8-ac7e-f3de8668645c Rius-Díaz, F. (Francisca)|||/items/b9312d2e-c945-417f-9d12-7a92b856b47b Valdes, S. (Sergio)|||/items/018ae2cf-0a02-4601-bc06-8b62452b3319 Martínez-González, M.A. (Miguel Ángel)|||/items/8b591471-4165-4697-8534-cfa0ad5eb1b7 Jiménez-Moleón, J.J. (José Juan)|||/items/cb714f5d-4da0-4452-8033-a194006facec Tinahones, F.J. (Francisco J.)|||/items/3c469348-deec-4066-bd93-383e05813c10 |
| author_role |
author |
| author2 |
Barrios-Rodríguez, R. (Rocío)|||/items/a1817321-37c7-402b-b7bc-70d1464f3add Asenjo-Plaza, M. (Maite)|||/items/70f1d7d2-fb4e-441d-aff2-2b490ee6ee25 Ramos-Molina, B. (Bruno)|||/items/728f7858-ad11-4f2a-b259-7dd369f72220 Molina-Vega, M. (María)|||/items/00d2b443-7ffa-4abb-a997-a8fc772af24a Peinado-Guzmán, J. A. (José Antonio)|||/items/74ec3b93-c3d5-47d6-b8f0-95d9b528f48f Moreno-León, L. (Luis)|||/items/af529412-6d1b-47b7-956f-cd6fd200753a Yubero-Serrano, E.M. (Elena M.)|||/items/133e700d-159b-4eb8-ac7e-f3de8668645c Rius-Díaz, F. (Francisca)|||/items/b9312d2e-c945-417f-9d12-7a92b856b47b Valdes, S. (Sergio)|||/items/018ae2cf-0a02-4601-bc06-8b62452b3319 Martínez-González, M.A. (Miguel Ángel)|||/items/8b591471-4165-4697-8534-cfa0ad5eb1b7 Jiménez-Moleón, J.J. (José Juan)|||/items/cb714f5d-4da0-4452-8033-a194006facec Tinahones, F.J. (Francisco J.)|||/items/3c469348-deec-4066-bd93-383e05813c10 |
| author2_role |
author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Dadun. Depósito Académico Digital Universidad de Navarra |
| dc.subject.none.fl_str_mv |
Erectile dysfunction Insulin resistance Metformin Obesity Testosterone |
| topic |
Erectile dysfunction Insulin resistance Metformin Obesity Testosterone |
| description |
Background: 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. Methods: 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). Results: 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 < 0.001). Combination therapy was not superior to testosterone alone in decreasing insulin resistance (-0.7, 95 % CI -2.3 to 0.9, p = 0.383). Only the combination of metformin plus testosterone significantly increased total and free testosterone concentrations, compared to placebo. No significant changes in body composition (except for a higher decrease in fat mass in the metformin and combination group), metabolic variables, erectile function, or HRQoL were found with any treatment. Conclusions: 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. |
| publishDate |
2022 |
| dc.date.none.fl_str_mv |
2022 2022-01-01 2022 2022-01-01 |
| dc.type.none.fl_str_mv |
journal article http://purl.org/coar/resource_type/c_6501 |
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info:eu-repo/semantics/article |
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article |
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https://hdl.handle.net/10171/124546 |
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https://hdl.handle.net/10171/124546 |
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Inglés eng |
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Inglés |
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eng |
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open access http://purl.org/coar/access_right/c_abf2 |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 |
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openAccess |
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application/pdf |
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Elsevier |
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Elsevier |
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reponame:Dadun. Depósito Académico Digital de la Universidad de Navarra instname:Universidad de Navarra |
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Universidad de Navarra |
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