Testosterone replacement in hypogonadal men with type 2 diabetes and/or metabolic syndrome (the TIMES2 study)
Open accessAbstract
OBJECTIVE: This study evaluated the effects of testosterone replacement therapy (TRT) on insulin resistance, cardiovascular risk factors, and symptoms in hypogonadal men with type 2 diabetes and/or metabolic syndrome (MetS). RESEARCH DESIGN AND METHODS: The efficacy, safety, and tolerability of a novel transdermal 2% testosterone gel was evaluated over 12 months in 220 hypogonadal men with type 2 diabetes and/or MetS in a multicenter, prospective, randomized, double-blind, placebo-controlled study. The primary outcome was mean change from baseline in homeostasis model assessment of insulin resistance (HOMA-IR). Secondary outcomes were measures of body composition, glycemic control, lipids, and sexual function. Efficacy results focused primarily on months 0-6 (phase 1; no changes in medication allowed). Medication changes were allowed in phase 2 (months 6-12). RESULTS: TRT reduced HOMA-IR in the overall population by 15.2% at 6 months (P = 0.018) and 16.4% at 12 months (P = 0.006). In type 2 diabetic patients, glycemic control was significantly better in the TRT group than the placebo group at month 9 (HbA(1c): treatment difference, -0.446%; P = 0.035). Improvements in total and LDL cholesterol, lipoprotein a (Lpa), body composition, libido, and sexual function occurred in selected patient groups. There were no significant differences between groups in the frequencies of adverse events (AEs) or serious AEs. The majority of AEs (>95%) were mild or moderate. CONCLUSIONS: Over a 6-month period, transdermal TRT was associated with beneficial effects on insulin resistance, total and LDL-cholesterol, Lpa, and sexual health in hypogonadal men with type 2 diabetes and/or MetS.
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Substantial evidence implicates testosterone and cortisol in the development of insulin resistance.
“substantial evidence implicate testosterone and cortisol in the development of insulin resistance.”
From Sleep, testosterone and cortisol balance, and ageing men (2022) · cites this paper as [89]
The Conclusions (page not provided) report that testosterone replacement improved insulin resistance in hypogonadal men with type 2 diabetes and/or metabolic syndrome, supporting a role for testosterone. The paper does not address cortisol, and its treatment finding does not establish how insulin resistance develops. (LLM, conf=0.88)
Experimental — accuracy not yet measuredTestosterone treatment improves glycemic control in men with T2DM.
“improves glycemic control in men with T2DM [89].”
From Sleep, testosterone and cortisol balance, and ageing men (2022) · cites this paper as [89]
The Results (Efficacy: Phase 2) report a significant HbA1c difference at nine months in men with type 2 diabetes. But the Conclusions say no reduction was demonstrated at six months and the nine-month finding was confounded by permitted medication changes, so the study could not clearly conclude that treatment improves glycemic control. The claim also omits that the participants were hypogonadal men. (LLM, conf=0.88)
Experimental — accuracy not yet measuredSome studies and meta-analyses highlighted that TRT may reduce body weight in obese men.
“While some studies and meta-analyses highlighted that TRT may reduce body weight in obese men (34, 35, 36, 37)”
From Effects of liraglutide on obesity-associated functional hypogonadism in men (2019) · cites this paper as [34]
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- Authors
- Jones, T. H., Arver, S., Behre, H. M., Buvat, J., Meuleman, E., Moncada, I., Morales, A. M., Volterrani, M., Yellowlees, A., Howell, J. D., Channer, K. S., & TIMES2 Investigators
- Affiliations
- Barnsley Hospital NHS Foundation Trust (GB)
- Karolinska University Hospital (SE)
- University Hospital in Halle (DE)
- Centre d’Etudes et de Traitement de la Pathologie de l’Appareil Reproducteur et de la Psychosomatique (CETPARP), Lille, France
- Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
- Hospital Universitario Sanitas La Zarzuela (ES)
- Department of Urology, Carlos Haya University Hospital, Malaga, Spain
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
- Quantics Consulting Limited, Tweed Horizons, Newtown St Boswells, Scottish Borders, U.K.
- Kyowa Kirin Farmacéutica, S.L.U. (Spain) (ES)
- Royal Hallamshire Hospital (GB)
- Corresponding author
- Jones, T. Hugh
- Venue
- Diabetes Care
- Publisher
- American Diabetes Association
- Published
- 2011-03-21
- Volume
- 34
- Issue
- 4
- Pages
- 828-837
- ISSN
- 0149-5992 (ISSN-L)
- 1935-5548
- PMC
- PMC3064036
- OpenAlex
- W2102179430
- Cited by
- 548
- References
- 26
- Citations by year
- 2026: 17 · 2025: 16 · 2024: 25 · 2023: 20 · 2022: 31 · 2021: 30 · 2020: 29 · 2019: 32 · 2018: 39 · 2017: 36 · 2016: 41 · 2015: 56 · 2014: 72 · 2013: 48 · 2012: 42
- FWCI
- 45.86
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Diabetes Care (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Ipsen
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Menopause: Health Impacts and Treatments
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Keywords
- testosterone replacement therapy, hypogonadism, type 2 diabetes, metabolic syndrome, insulin resistance, transdermal testosterone gel, glycemic control, HbA1c, LDL cholesterol, lipoprotein(a), body composition, sexual function, cardiovascular risk factors
- MeSH terms
- Adult, Aged, Aged, 80 and over, Body Composition, Diabetes Mellitus, Type 2, Humans, Hypogonadism, Insulin Resistance, Male, Middle Aged, Testosterone, Metabolic Syndrome
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Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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