Effects of testosterone supplementation on markers of the metabolic syndrome and inflammation in hypogonadal men with the metabolic syndrome: the double‐blinded placebo‐controlled Moscow study

Kalinchenko, Svetlana; Tishova, Yuliya; Mskhalaya, George; Gooren, Louis; Giltay, Erik J.; Saad, Farid

doi:10.1111/j.1365-2265.2010.03845.x

Cited by 321 publications

(297 citation statements)

References 70 publications

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“…Previous RCTs of testosterone therapy in men with diabetes or the metabolic syndrome, summarized in Supplementary Table 1, yielded inconsistent outcomes (20,(35)(36)(37). The largest RCT, although unpublished, in 180 men with T2D did not report any significant changes in HOMA-IR or HbA 1c (accessed at http:// www.solvaypharmaceuticals.com/static/ wma/pdf/1/3/4/4/2/S176.2.101.pdf).…”

Section: Discussionmentioning

confidence: 99%

“…Dropout rates were 29% at 6 months and 46% at 12 months (37). A 30-week RCT of testosterone therapy conducted in 184 men with the metabolic syndrome, 56 of whom had T2D, showed a 31% improvement in HOMA-IR with testosterone treatment, in association with significant weight loss (24.3 kg), although changes in body composition were not assessed (36). The findings in these RCTs are consistent with the possibility that testosterone treatment may have more favorable effects on glucose metabolism in men without established diabetes.…”

Section: Discussionmentioning

confidence: 99%

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Effect of Testosterone Treatment on Glucose Metabolism in Men With Type 2 Diabetes: A Randomized Controlled Trial

et al. 2014

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OBJECTIVETo determine whether testosterone therapy improves glucose metabolism in men with type 2 diabetes (T2D) and lowered testosterone. RESEARCH DESIGN AND METHODSWe conducted a randomized, double-blind, parallel, placebo-controlled trial in 88 men with T2D, aged 35-70 years with an HbA 1c £8.5% (69 mmol/mol), and a total testosterone level, measured by immunoassay, of £12.0 nmol/L (346 ng/dL). Participants were randomly assigned to 40 weeks of intramuscular testosterone undecanoate (n = 45) or matching placebo (n = 43). All study subjects were included in the primary analysis. Seven men assigned to testosterone and six men receiving placebo did not complete the study. Main outcome measures were insulin resistance by homeostatic model assessment (HOMA-IR, primary outcome) and glycemic control by HbA 1c (secondary outcome). CONCLUSIONSTestosterone therapy does not improve glucose metabolism or visceral adiposity in obese men with moderately controlled T2D and modest reductions in circulating testosterone levels typical for men with T2D.Observational studies consistently show that 30-50% of men with type 2 diabetes (T2D) have lowered circulating testosterone levels, relative to references based on healthy young men (1-3). This association is independent of age and obesity (4,5), and low testosterone levels in men with T2D are independently associated with insulin resistance (3). However, it is not known whether low testosterone levels are a cause or a consequence of T2D or its associated clinical features. Several lines of evidence lend support to the hypothesis that testosterone treatment decreases insulin resistance. Experimental evidence, reviewed in Grossmann

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Effect of Testosterone Treatment on Glucose Metabolism in Men With Type 2 Diabetes: A Randomized Controlled Trial

et al. 2014

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“…84 A randomized, placebo-controlled, doubleblind trial of 184 men with hypogonadism and metabolic syndrome showed that intramuscular administration of testosterone undecanoate decreased plasma levels of interleukin-1b, tumor necrosis factor-a and C-reactive protein in association with reductions in body mass index and waist circumference, while interleukin-6 and interleukin-10 did not change significantly. 85 Taken together, testosterone administration, at least in hypogonadal men, may have a favorable vascular effect, including endotheliumdependent or -independent vasodilation and reduction of arterial stiffness and inflammatory markers. In contrast, the effects of testosterone replacement on the progression of carotid intima-media thickness or other atherosclerotic lesions, as well as on CVD risk, 86 are unknown.…”

Section: Clinical Effects Of Androgen Replacement Therapymentioning

confidence: 99%

Hormonal effects on blood vessels

Akishita

2012

Hypertens Res

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The incidence of cardiovascular disease (CVD) is lower in younger women than in men of the same age, but it increases after menopause, implicating the atheroprotective action of endogenous estrogen. Although observational studies have suggested the efficacy of estrogen therapy in postmenopausal women, placebo-controlled, randomized trials, such as the Women's Health Initiative, have not confirmed effects of estrogen therapy on CVD. Conversely, basic, experimental research has progressed and provided mechanistic insight into estrogen's action on blood vessels. By contrast, the vascular effects of androgens remain poorly understood and have been controversial for a long time. In recent years, an increasing body of evidence has suggested that androgens may exert protective effects against the development of atherosclerosis, at least in elderly men. Epidemiological studies have shown that the incidence of and mortality due to CVD were increased in elderly men with low testosterone levels, although the efficacy of androgen therapy remains unknown. Furthermore, recent experimental studies have demonstrated the direct action of androgens on the vasculature. In this review, we illustrate the effects of sex steroids on the cardiovascular system, focusing on the action of testosterone on the blood vessels.

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“…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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Effects of testosterone supplementation on markers of the metabolic syndrome and inflammation in hypogonadal men with the metabolic syndrome: the double‐blinded placebo‐controlled Moscow study

Cited by 321 publications

References 70 publications

Effect of Testosterone Treatment on Glucose Metabolism in Men With Type 2 Diabetes: A Randomized Controlled Trial

Effect of Testosterone Treatment on Glucose Metabolism in Men With Type 2 Diabetes: A Randomized Controlled Trial

Hormonal effects on blood vessels

Testosterone and glucose metabolism in men: current concepts and controversies

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