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Glycemic Variability in Subjects with Diabetes and Hypogonadism during Testosterone Replacement Treatment: A Pilot Study

Background: This is a proof of concept, as a pilot study, with the aim to evaluate continuous glucose monitoring metrics (CGM) in subjects with type 2 diabetes (T2DM), treated with nutritional therapy and metformin, before and after testosterone replacement therapy (TRT). Methods: In this longitudin...

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Autores principales: Defeudis, Giuseppe, Maddaloni, Ernesto, Rossini, Giovanni, Di Tommaso, Alfonso Maria, Mazzilli, Rossella, Di Palma, Paolo, Pozzilli, Paolo, Napoli, Nicola
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9505941/
https://www.ncbi.nlm.nih.gov/pubmed/36142982
http://dx.doi.org/10.3390/jcm11185333
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author Defeudis, Giuseppe
Maddaloni, Ernesto
Rossini, Giovanni
Di Tommaso, Alfonso Maria
Mazzilli, Rossella
Di Palma, Paolo
Pozzilli, Paolo
Napoli, Nicola
author_facet Defeudis, Giuseppe
Maddaloni, Ernesto
Rossini, Giovanni
Di Tommaso, Alfonso Maria
Mazzilli, Rossella
Di Palma, Paolo
Pozzilli, Paolo
Napoli, Nicola
author_sort Defeudis, Giuseppe
collection PubMed
description Background: This is a proof of concept, as a pilot study, with the aim to evaluate continuous glucose monitoring metrics (CGM) in subjects with type 2 diabetes (T2DM), treated with nutritional therapy and metformin, before and after testosterone replacement therapy (TRT). Methods: In this longitudinal observational study, subjects affected by T2DM and starting TRT for documented ED and hypogonadism were enrolled. All subjects mounted a CGM system during the v0 visit, one week before the beginning of the TRT (week−1), during v2, four weeks after the start of TRT (week 4), and v4 (week 12). CGM was worn for about 144 h after each visit. Results: A total of seven patients, referring to our clinic for erectile dysfunction (ED), were studied (aged 63.3 ± 2.3 years). Mean (± standard deviation) total testosterone level was 2.3 ± 0.6 ng/mL at baseline. After TRT, total testosterone level was 4.6 ± 3.04 ng/mL at week 4 and 3.93 ± 4.67 ng/mL at week 12. No significant differences were observed in TIR, TAR, TBR, estimated HbA1c, AUC below, and AUC above limit during the intervention period. Conclusions: This is the first study evaluating the effects of TRT on daily glucose excursions in subjects with T2DM and hypogonadism. Though we did not find any significant difference in key CGM metrics during the 12 weeks of TRT, this study confirms the glycometabolic safety of the TRT even on the most novel standardized glycemic targets.
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spelling pubmed-95059412022-09-24 Glycemic Variability in Subjects with Diabetes and Hypogonadism during Testosterone Replacement Treatment: A Pilot Study Defeudis, Giuseppe Maddaloni, Ernesto Rossini, Giovanni Di Tommaso, Alfonso Maria Mazzilli, Rossella Di Palma, Paolo Pozzilli, Paolo Napoli, Nicola J Clin Med Article Background: This is a proof of concept, as a pilot study, with the aim to evaluate continuous glucose monitoring metrics (CGM) in subjects with type 2 diabetes (T2DM), treated with nutritional therapy and metformin, before and after testosterone replacement therapy (TRT). Methods: In this longitudinal observational study, subjects affected by T2DM and starting TRT for documented ED and hypogonadism were enrolled. All subjects mounted a CGM system during the v0 visit, one week before the beginning of the TRT (week−1), during v2, four weeks after the start of TRT (week 4), and v4 (week 12). CGM was worn for about 144 h after each visit. Results: A total of seven patients, referring to our clinic for erectile dysfunction (ED), were studied (aged 63.3 ± 2.3 years). Mean (± standard deviation) total testosterone level was 2.3 ± 0.6 ng/mL at baseline. After TRT, total testosterone level was 4.6 ± 3.04 ng/mL at week 4 and 3.93 ± 4.67 ng/mL at week 12. No significant differences were observed in TIR, TAR, TBR, estimated HbA1c, AUC below, and AUC above limit during the intervention period. Conclusions: This is the first study evaluating the effects of TRT on daily glucose excursions in subjects with T2DM and hypogonadism. Though we did not find any significant difference in key CGM metrics during the 12 weeks of TRT, this study confirms the glycometabolic safety of the TRT even on the most novel standardized glycemic targets. MDPI 2022-09-11 /pmc/articles/PMC9505941/ /pubmed/36142982 http://dx.doi.org/10.3390/jcm11185333 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Defeudis, Giuseppe
Maddaloni, Ernesto
Rossini, Giovanni
Di Tommaso, Alfonso Maria
Mazzilli, Rossella
Di Palma, Paolo
Pozzilli, Paolo
Napoli, Nicola
Glycemic Variability in Subjects with Diabetes and Hypogonadism during Testosterone Replacement Treatment: A Pilot Study
title Glycemic Variability in Subjects with Diabetes and Hypogonadism during Testosterone Replacement Treatment: A Pilot Study
title_full Glycemic Variability in Subjects with Diabetes and Hypogonadism during Testosterone Replacement Treatment: A Pilot Study
title_fullStr Glycemic Variability in Subjects with Diabetes and Hypogonadism during Testosterone Replacement Treatment: A Pilot Study
title_full_unstemmed Glycemic Variability in Subjects with Diabetes and Hypogonadism during Testosterone Replacement Treatment: A Pilot Study
title_short Glycemic Variability in Subjects with Diabetes and Hypogonadism during Testosterone Replacement Treatment: A Pilot Study
title_sort glycemic variability in subjects with diabetes and hypogonadism during testosterone replacement treatment: a pilot study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9505941/
https://www.ncbi.nlm.nih.gov/pubmed/36142982
http://dx.doi.org/10.3390/jcm11185333
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