Reduced testis volume in eugonadal men treated with testosterone is well-recognised. This sub-study of the Testosterone for the Prevention of Type 2 Diabetes (T4DM) Trial investigated i) baseline determinants of testis volume, ii) changes in testis volume over 2 years following randomisation to testosterone or placebo, and iii) the effect of changes in fat mass (DXA), BMI, and waist circumference (WC) on testis volume.
T4DM enrolled men aged 50-74 years, with impaired glucose tolerance or early type 2 diabetes, WC ≥95cm, serum testosterone ≤14 nmol/L and without pathological hypogonadism. All were enrolled in Weight-Watchers (WW) and randomised to 2 years treatment with testosterone undecanoate (1000 mg IM 3 monthly) or matching placebo. At one study centre, a single investigator (WJI) measured testis volume (Prader orchidometer) at baseline and final visits while blinded to treatment assignment.
The sub-study participants (n=123, 63 testosterone 60 placebo) were similar in age to the whole T4DM cohort but had higher weight (p=0.036), waist circumference (p=0.005), and BMI-graded obesity (p=0.004). Baseline testis volume was 19.4±4 ml and was inversely correlated with serum FSH (p=0.001) and LH (p=0.004), but not adiposity measures.
At 2 years, testis volume of testosterone-treated men was reduced by 5.9 ml (95% CI 4.6-7.2) more than placebo recipients (p<0.001), while the changes in BMI (Testosterone -1.7±2.3 kg/m2 v Placebo -1.7±2.7 kg/m2), fat mass (Testosterone -4.3±5.7 kg v Placebo -2.1±7.3 kg) and WC (Testosterone -6.8±5.7 cm v Placebo -4.8±7.3 cm) were not significantly different. However, reduced adiposity was associated with lower testis volume in testosterone-treated men, but with higher testis volume in placebo-treated men (treatment x fat mass interaction p-int=0.012; treatment x WC, p-int=0.01).
Two years of testosterone treatment in men with dysglycaemia reduced testis volume and was associated with decreased adiposity. However, in placebo-treated men, reduced adiposity was associated with increased testis volume.