Testosterone Replacement in Hypogonadal Men With Type 2 Diabetes and/or Metabolic Syndrome (the TIMES2 Study)

Jones, T Hugh; Arver, Stefan; Behre, Hermann M.; Buvat, J; Meuleman, E.J.H.; Moncada, Ignacio; Morales, Antonio Martín; Volterrani, Maurizio; Yellowlees, Ann; Howell, Julian; Channer, KS

doi:10.2337/dc10-1233

Cited by 485 publications

(484 citation statements)

References 25 publications

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“…26 Any benefit on glucose metabolism or visceral adiposity in obese men with type 2 diabetes could not be demonstrated in another recent trial. 27 Wang et al summarised the results of several trials that evaluated the metabolic effect of testosterone replacement.…”

Section: Discussionmentioning

confidence: 99%

The prevalence and association of low testosterone levels in a South African male, diabetic, urban population

Kemp

Rheeder

2015

Journal of Endocrinology, Metabolism and Diabetes of South Afri

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Background: According to the literature, low serum testosterone levels are associated with diabetes mellitus. No or minimal data exist for its prevalence or predictors in South Africa. Design: This was a cross-sectional study. Setting: The setting was an academic centre, i.e. the University of Pretoria and Steve Biko Academic Hospital Diabetes Clinic. Subjects: A total of 150 consecutive male patients aged 50 years and older with diabetes mellitus were selected using convenience sampling. Outcome measures: The patients were evaluated for diabetes control and complications, and for hypogonadism symptoms. Early-morning serum testosterone levels were determined. Results: The prevalence of androgen deficiency symptoms was 94.7%. Some 50% of the men had low total testosterone levels. Using multivariate logistic regression, the significant factors associated with low total testosterone were waist circumference and known cardiovascular disease. The prevalence of symptoms of androgen deficiency was very high; 94.7% of the patients reported a significant number of symptoms listed on the Androgen Deficiency in the Aging Male questionnaire. Conclusion: This study confirms the high prevalence of low testosterone levels in diabetic male patients in a tertiary setting. Universal screening remains controversial owing to uncertainty regarding the risks and benefits of testosterone therapy in this population group. Predictors of low testosterone levels were identified.

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Section: Discussionmentioning

confidence: 99%

The prevalence and association of low testosterone levels in a South African male, diabetic, urban population

Kemp

Rheeder

2015

Journal of Endocrinology, Metabolism and Diabetes of South Afri

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“…[62][63][64][65] In the TIMES2 (Testosterone Replacement In Hypogonadal Men With Either Metabolic Syndrome or Type 2 Diabetes) study, 6 to 12 months of transdermal TRT (vs placebo) significantly improved insulin resistance and glycemic control in a large randomized study of hypogonadal men with type 2 diabetes mellitus (ACCF/AHA class Ib). 66 A meta-analysis of 5 other randomized controlled trials (including 3 placebo-controlled trials) with mean follow-up of 58 weeks found that TRT was associated with a significant reduction in fasting plasma glucose levels, homeostasis model assessment of insulin resistance index, triglycerides, and WC. An increase in HDL cholesterol level was also observed, whereas no significant differences were observed for total cholesterol level, BP, or BMI.…”

Section: Recommended Assessments and Risk Clarificationmentioning

confidence: 99%

The Princeton III Consensus Recommendations for the Management of Erectile Dysfunction and Cardiovascular Disease

Nehra

Jackson

Miner

et al. 2012

Mayo Clinic Proceedings

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417

341

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The Princeton Consensus (Expert Panel) Conference is a multispecialty collaborative tradition dedicated to optimizing sexual function and preserving cardiovascular health. The third Princeton Consensus met November 8 to 10, 2010, and had 2 primary objectives. The first objective focused on the evaluation and management of cardiovascular risk in men with erectile dysfunction (ED) and no known cardiovascular disease (CVD), with particular emphasis on identification of men with ED who may require additional cardiologic work-up. The second objective focused on reevaluation and modification of previous recommendations for evaluation of cardiac risk associated with sexual activity in men with known CVD. The Panel's recommendations build on those developed during the first and second Princeton Consensus Conferences, first emphasizing the use of exercise ability and stress testing to ensure that each man's cardiovascular health is consistent with the physical demands of sexual activity before prescribing treatment for ED, and second highlighting the link between ED and CVD, which may be asymptomatic and may benefit from cardiovascular risk reduction. T he Princeton Consensus Conference is a multispecialty collaborative tradition dedicated to optimizing sexual function and preserving cardiovascular health. The first conference convened in June 1999 to develop recommendations for clinical management of sexual dysfunction in men and women with known cardiovascular disease (CVD). This conference also provided a multidisciplinary forum for evaluation of the potential cardiovascular risk posed by sexual activity in atrisk patients. The first Princeton Consensus Conference recommendations 1 included stratification of patients by level of cardiac risk associated with sexual activity based on existing CVD. Those at low risk could initiate or resume sexual activity and be treated for sexual dysfunction. For those at high risk, sexual activity was deferred until the cardiac condition was stabilized. The second Princeton Consensus Conference convened in June 2004 and expanded the recommendations of the first conference to emphasize risk factor evaluation and lifestyle management for all men with erectile dysfunction (ED). 2 The second conference recommendations also incorporated new information on the appropriate use of phosphodiesterase type 5 (PDE5) inhibitors in men with ED and concomitant CVD.The third Princeton Consensus Conference took place November 8 to 10, 2010, in Miami Beach, Florida. The group revisited and updated their 2005 recommendations regarding the cardiovascular risk associated with sexual activity in men with known CVD. 2 In addition, the third conference focused on the predictive value of vasculogenic ED in assigning cardiovascular risk in men of all ages, with the primary objective being development of an approach to cardiovascular risk assessment in younger men with ED and no known CVD. The role of testosterone in erectile function and cardiovascular health and the utility of testosterone replacement...

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“…The effects of testosterone treatment on lipids in double-blind placebo-controlled RCTs are shown in Table 2. In the TIMES2 study Jones et al (2011) found not only a significant decrease in lipoprotein a (Lpa), an independent risk factor for cardiovascular disease, but also a significant decrease in the theoretically protective HDL cholesterol. Patients with metabolic syndrome additionally had reduced total and LDL cholesterol after 6 months of testosterone therapy compared with placebo (Table 2).…”

Section: Testosterone Lipids and Blood Pressurementioning

confidence: 99%

“…Six RCTs have been conducted to date specifically in men with diabetes or the metabolic syndrome (Kapoor et al 2006, Gopal et al 2010, Kalinchenko et al 2010, Jones et al 2011; Tables 1 and 2). One was never unpublished (http://www.solvaypharmaceuticals.com/ static/wma/pdf/1/3/4/4/2/S176.2.101.pdf) and one has been presented in preliminary abstract form (Hackett et al 2013).…”

Section: Testosterone Treatment In Men With Metabolic Disordersmentioning

confidence: 99%

Testosterone and glucose metabolism in men: current concepts and controversies

Grossmann¹

2013

Journal of Endocrinology

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A wealth of observational studies show that low testosterone is associated with insulin resistance and with an increased risk of diabetes and the metabolic syndrome. Experimental studies have identified potential mechanisms by which low testosterone may lead to insulin resistance. Visceral adipose tissue is an important intermediate in this relationship. Actions of testosterone or its metabolite oestradiol on other tissues such as muscle, liver, bone or the brain, and body composition-independent effects may also play a role. However, definitive evidence from randomised controlled trials (RCTs) to clarify whether the association of low testosterone with disordered glucose metabolism is causative is currently lacking. It therefore remains possible that this association is due to reverse causation, or simply originates by association with common health and lifestyle factors. RCTs of testosterone therapy in men with or without diabetes consistently show modest metabolically favourable changes in body composition. Despite this, testosterone effects on glucose metabolism have been inconsistent. Recent evidence suggests that the hypothalamic-pituitary-testicular axis suppression in the majority of obese men with metabolic disorders is functional, and may be, at least in part, reversible with weight loss. Until further evidence is available, lifestyle measures with emphasis on weight reduction, treatment of comorbidities and optimisation of diabetic control should remain the first-line treatment in these men. Such measures, if successful, may be sufficient to normalise testosterone levels in men with metabolic disorders, who typically have only modest reductions in circulating testosterone levels.

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Testosterone Replacement in Hypogonadal Men With Type 2 Diabetes and/or Metabolic Syndrome (the TIMES2 Study)

Cited by 485 publications

References 25 publications

The prevalence and association of low testosterone levels in a South African male, diabetic, urban population

The prevalence and association of low testosterone levels in a South African male, diabetic, urban population

The Princeton III Consensus Recommendations for the Management of Erectile Dysfunction and Cardiovascular Disease

Testosterone and glucose metabolism in men: current concepts and controversies

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