Metformin, testosterone, or both in men with obesity and low testosterone: A double-blind, parallel-group, randomized controlled trial
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 tria...
Gespeichert in:
| Veröffentlicht in: | Metabolism, clinical and experimental clinical and experimental, 2022-11, Vol.136, p.155290-155290, Article 155290 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 155290 |
|---|---|
| container_issue | |
| container_start_page | 155290 |
| container_title | Metabolism, clinical and experimental |
| container_volume | 136 |
| creator | Fernández-García, José Carlos Barrios-Rodríguez, Rocío Asenjo-Plaza, Maite Ramos-Molina, Bruno Molina-Vega, María Guzmán-Guzmán, Antonio Moreno-León, Luis Yubero-Serrano, Elena M. Rius-Díaz, Francisca Valdés, Sergio Martínez-González, Miguel Ángel Jiménez-Moleón, José Juan Tinahones, Francisco J. |
| description | 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 |
| doi_str_mv | 10.1016/j.metabol.2022.155290 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2704872152</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0026049522001688</els_id><sourcerecordid>2704872152</sourcerecordid><originalsourceid>FETCH-LOGICAL-c389t-1e39c502b83a30d101d5f4aaa3dcda0e9026b3faaa60d4cee193d6e33dbc0f3d3</originalsourceid><addsrcrecordid>eNqFkMFOHDEMhqOqlbqlPEKlHHvYWZxkZ3amF4RQW5BAXOAcZRIPZJWJlyRbBA_Q527QcumJky37_y3_H2PfBKwEiO5ku5qxmJHCSoKUK9G2coAPbCFaJZu-A_jIFgCya2A9tJ_Zl5y3ALDZ9N2C_b3GMlGafVzygrlQLpgo4pJT4iOVB-4jnzHyJ197GjH78sxNdDzQ03-OH_yMO9qPAZsx-OiWfGeSCQFDc59ov1vyVG00-xd03FIsierS8ZK8CV_Zp8mEjMdv9Yjd_fp5e37RXN38vjw_u2qs6ofSCFSDbUGOvTIKXE3v2mltjFHOOgM41JSjmuqgA7e2iGJQrkOl3GhhUk4dse-Hu7tEj_v6vZ59thiCiUj7rOUG1v1GilZWaXuQ2kQ5J5z0LvnZpGctQL9y11v9xl2_ctcH7tV3evBhzfHHY9LZeowWnU9oi3bk37nwD-Zdkeo</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2704872152</pqid></control><display><type>article</type><title>Metformin, testosterone, or both in men with obesity and low testosterone: A double-blind, parallel-group, randomized controlled trial</title><source>Elsevier ScienceDirect Journals</source><creator>Fernández-García, José Carlos ; Barrios-Rodríguez, Rocío ; Asenjo-Plaza, Maite ; Ramos-Molina, Bruno ; Molina-Vega, María ; Guzmán-Guzmán, Antonio ; Moreno-León, Luis ; Yubero-Serrano, Elena M. ; Rius-Díaz, Francisca ; Valdés, Sergio ; Martínez-González, Miguel Ángel ; Jiménez-Moleón, José Juan ; Tinahones, Francisco J.</creator><creatorcontrib>Fernández-García, José Carlos ; Barrios-Rodríguez, Rocío ; Asenjo-Plaza, Maite ; Ramos-Molina, Bruno ; Molina-Vega, María ; Guzmán-Guzmán, Antonio ; Moreno-León, Luis ; Yubero-Serrano, Elena M. ; Rius-Díaz, Francisca ; Valdés, Sergio ; Martínez-González, Miguel Ángel ; Jiménez-Moleón, José Juan ; Tinahones, Francisco J.</creatorcontrib><description>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 < 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.
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.
[Display omitted]
•Men with obesity tend to be insulin resistant and often have low-normal testosterone concentrations.•We conducted a randomized, double-blind, placebo-controlled trial of metformin, testosterone, or both, with the endpoint of insulin resistance.•Metformin only, testosterone only, and the combination of metformin plus testosterone reduced insulin resistance with no evidence of additive benefit.</description><identifier>ISSN: 0026-0495</identifier><identifier>EISSN: 1532-8600</identifier><identifier>DOI: 10.1016/j.metabol.2022.155290</identifier><language>eng</language><publisher>Elsevier Inc</publisher><subject>Erectile dysfunction ; Insulin resistance ; Metformin ; Obesity ; Testosterone</subject><ispartof>Metabolism, clinical and experimental, 2022-11, Vol.136, p.155290-155290, Article 155290</ispartof><rights>2022 Elsevier Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c389t-1e39c502b83a30d101d5f4aaa3dcda0e9026b3faaa60d4cee193d6e33dbc0f3d3</citedby><cites>FETCH-LOGICAL-c389t-1e39c502b83a30d101d5f4aaa3dcda0e9026b3faaa60d4cee193d6e33dbc0f3d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0026049522001688$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids></links><search><creatorcontrib>Fernández-García, José Carlos</creatorcontrib><creatorcontrib>Barrios-Rodríguez, Rocío</creatorcontrib><creatorcontrib>Asenjo-Plaza, Maite</creatorcontrib><creatorcontrib>Ramos-Molina, Bruno</creatorcontrib><creatorcontrib>Molina-Vega, María</creatorcontrib><creatorcontrib>Guzmán-Guzmán, Antonio</creatorcontrib><creatorcontrib>Moreno-León, Luis</creatorcontrib><creatorcontrib>Yubero-Serrano, Elena M.</creatorcontrib><creatorcontrib>Rius-Díaz, Francisca</creatorcontrib><creatorcontrib>Valdés, Sergio</creatorcontrib><creatorcontrib>Martínez-González, Miguel Ángel</creatorcontrib><creatorcontrib>Jiménez-Moleón, José Juan</creatorcontrib><creatorcontrib>Tinahones, Francisco J.</creatorcontrib><title>Metformin, testosterone, or both in men with obesity and low testosterone: A double-blind, parallel-group, randomized controlled trial</title><title>Metabolism, clinical and experimental</title><description>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 < 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.
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.
[Display omitted]
•Men with obesity tend to be insulin resistant and often have low-normal testosterone concentrations.•We conducted a randomized, double-blind, placebo-controlled trial of metformin, testosterone, or both, with the endpoint of insulin resistance.•Metformin only, testosterone only, and the combination of metformin plus testosterone reduced insulin resistance with no evidence of additive benefit.</description><subject>Erectile dysfunction</subject><subject>Insulin resistance</subject><subject>Metformin</subject><subject>Obesity</subject><subject>Testosterone</subject><issn>0026-0495</issn><issn>1532-8600</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNqFkMFOHDEMhqOqlbqlPEKlHHvYWZxkZ3amF4RQW5BAXOAcZRIPZJWJlyRbBA_Q527QcumJky37_y3_H2PfBKwEiO5ku5qxmJHCSoKUK9G2coAPbCFaJZu-A_jIFgCya2A9tJ_Zl5y3ALDZ9N2C_b3GMlGafVzygrlQLpgo4pJT4iOVB-4jnzHyJ197GjH78sxNdDzQ03-OH_yMO9qPAZsx-OiWfGeSCQFDc59ov1vyVG00-xd03FIsierS8ZK8CV_Zp8mEjMdv9Yjd_fp5e37RXN38vjw_u2qs6ofSCFSDbUGOvTIKXE3v2mltjFHOOgM41JSjmuqgA7e2iGJQrkOl3GhhUk4dse-Hu7tEj_v6vZ59thiCiUj7rOUG1v1GilZWaXuQ2kQ5J5z0LvnZpGctQL9y11v9xl2_ctcH7tV3evBhzfHHY9LZeowWnU9oi3bk37nwD-Zdkeo</recordid><startdate>202211</startdate><enddate>202211</enddate><creator>Fernández-García, José Carlos</creator><creator>Barrios-Rodríguez, Rocío</creator><creator>Asenjo-Plaza, Maite</creator><creator>Ramos-Molina, Bruno</creator><creator>Molina-Vega, María</creator><creator>Guzmán-Guzmán, Antonio</creator><creator>Moreno-León, Luis</creator><creator>Yubero-Serrano, Elena M.</creator><creator>Rius-Díaz, Francisca</creator><creator>Valdés, Sergio</creator><creator>Martínez-González, Miguel Ángel</creator><creator>Jiménez-Moleón, José Juan</creator><creator>Tinahones, Francisco J.</creator><general>Elsevier Inc</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202211</creationdate><title>Metformin, testosterone, or both in men with obesity and low testosterone: A double-blind, parallel-group, randomized controlled trial</title><author>Fernández-García, José Carlos ; Barrios-Rodríguez, Rocío ; Asenjo-Plaza, Maite ; Ramos-Molina, Bruno ; Molina-Vega, María ; Guzmán-Guzmán, Antonio ; Moreno-León, Luis ; Yubero-Serrano, Elena M. ; Rius-Díaz, Francisca ; Valdés, Sergio ; Martínez-González, Miguel Ángel ; Jiménez-Moleón, José Juan ; Tinahones, Francisco J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c389t-1e39c502b83a30d101d5f4aaa3dcda0e9026b3faaa60d4cee193d6e33dbc0f3d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Erectile dysfunction</topic><topic>Insulin resistance</topic><topic>Metformin</topic><topic>Obesity</topic><topic>Testosterone</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fernández-García, José Carlos</creatorcontrib><creatorcontrib>Barrios-Rodríguez, Rocío</creatorcontrib><creatorcontrib>Asenjo-Plaza, Maite</creatorcontrib><creatorcontrib>Ramos-Molina, Bruno</creatorcontrib><creatorcontrib>Molina-Vega, María</creatorcontrib><creatorcontrib>Guzmán-Guzmán, Antonio</creatorcontrib><creatorcontrib>Moreno-León, Luis</creatorcontrib><creatorcontrib>Yubero-Serrano, Elena M.</creatorcontrib><creatorcontrib>Rius-Díaz, Francisca</creatorcontrib><creatorcontrib>Valdés, Sergio</creatorcontrib><creatorcontrib>Martínez-González, Miguel Ángel</creatorcontrib><creatorcontrib>Jiménez-Moleón, José Juan</creatorcontrib><creatorcontrib>Tinahones, Francisco J.</creatorcontrib><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Metabolism, clinical and experimental</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fernández-García, José Carlos</au><au>Barrios-Rodríguez, Rocío</au><au>Asenjo-Plaza, Maite</au><au>Ramos-Molina, Bruno</au><au>Molina-Vega, María</au><au>Guzmán-Guzmán, Antonio</au><au>Moreno-León, Luis</au><au>Yubero-Serrano, Elena M.</au><au>Rius-Díaz, Francisca</au><au>Valdés, Sergio</au><au>Martínez-González, Miguel Ángel</au><au>Jiménez-Moleón, José Juan</au><au>Tinahones, Francisco J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Metformin, testosterone, or both in men with obesity and low testosterone: A double-blind, parallel-group, randomized controlled trial</atitle><jtitle>Metabolism, clinical and experimental</jtitle><date>2022-11</date><risdate>2022</risdate><volume>136</volume><spage>155290</spage><epage>155290</epage><pages>155290-155290</pages><artnum>155290</artnum><issn>0026-0495</issn><eissn>1532-8600</eissn><abstract>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 < 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.
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.
[Display omitted]
•Men with obesity tend to be insulin resistant and often have low-normal testosterone concentrations.•We conducted a randomized, double-blind, placebo-controlled trial of metformin, testosterone, or both, with the endpoint of insulin resistance.•Metformin only, testosterone only, and the combination of metformin plus testosterone reduced insulin resistance with no evidence of additive benefit.</abstract><pub>Elsevier Inc</pub><doi>10.1016/j.metabol.2022.155290</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0026-0495 |
| ispartof | Metabolism, clinical and experimental, 2022-11, Vol.136, p.155290-155290, Article 155290 |
| issn | 0026-0495 1532-8600 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2704872152 |
| source | Elsevier ScienceDirect Journals |
| subjects | Erectile dysfunction Insulin resistance Metformin Obesity Testosterone |
| title | Metformin, testosterone, or both in men with obesity and low testosterone: A double-blind, parallel-group, randomized controlled trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-10T01%3A05%3A42IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Metformin,%20testosterone,%20or%20both%20in%20men%20with%20obesity%20and%20low%20testosterone:%20A%20double-blind,%20parallel-group,%20randomized%20controlled%20trial&rft.jtitle=Metabolism,%20clinical%20and%20experimental&rft.au=Fern%C3%A1ndez-Garc%C3%ADa,%20Jos%C3%A9%20Carlos&rft.date=2022-11&rft.volume=136&rft.spage=155290&rft.epage=155290&rft.pages=155290-155290&rft.artnum=155290&rft.issn=0026-0495&rft.eissn=1532-8600&rft_id=info:doi/10.1016/j.metabol.2022.155290&rft_dat=%3Cproquest_cross%3E2704872152%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2704872152&rft_id=info:pmid/&rft_els_id=S0026049522001688&rfr_iscdi=true |