madman
Super Moderator
* T4DM RUNON sub-study extended the T4DM randomized, double-blind, placebo-controlled trial (n=1007) by 2 years, for a total of up to 4 years of treatment, without ongoing enrolment in the lifestyle program. Eligible and consenting participants (n=121) continued their original masked allocation to intramuscular testosterone undecanoate (1000mg 3 monthly) or placebo.
* In men with prediabetes or early T2DM, in the subgroup with continuing blinded T treatment for up to 4 years there were diminishing glycemic benefits and durable improvements in anthropometry and sexual desire, with an acceptable safety profile.
The T4DM trial found that in men aged 50 years and older with waist circumference (WC) ≥ 95cm and impaired glucose tolerance, 2 years treatment with testosterone (T) (vs placebo) together with a lifestyle program reduced the risk of type 2 diabetes (T2DM) diagnosis at 2 years by 40% compared with a lifestyle program alone (1). This effect was associated with a greater reduction in fat mass, increased skeletal muscle mass and strength and improved sexual function.
To evaluate the durability of T treatment effects on glycemia, anthropometry, sexual function, quality of life, and safety over four years, the T4DM RUNON sub-study extended the T4DM randomized, double-blind, placebo-controlled trial (n=1007) by 2 years, for a total of up to 4 years of treatment, without ongoing enrolment in the lifestyle program. Eligible and consenting participants (n=121) continued their original masked allocation to intramuscular testosterone undecanoate (1000mg 3 monthly) or placebo. Primary outcomes were glycemia (2-hour OGTT and fasting plasma glucose). Secondary outcomes included anthropometry, sexual function (IIEF), health-related quality of life (SF36), and safety measures.
The effect of T treatment on glycemia over 4 years was sustained as measured by mean difference in 2-hr OGTT glucose ( –1.0 mmol/L, 95% CI –1.7 to –0.88); fasting plasma glucose (–0.26 mmol/L, 95% CI –0.49 to –0.03) with most benefit in the first 2 years. For the proportion with 2-hr OGTT >11.1mmol/L a significant treatment effect at 2-years (P=0.27), was absent at 4-years (P=0.5). The 4-year adjusted mean differences in weight and WC between the T and placebo groups were -1.3kg (95% CI: -4.8 to 2.2) and –2.3cm (95%CI: -5.4 to 0.7), respectively. Most benefit occurred within the first 2 years. The improvement in sexual desire at 2 years, but not of other domains of sexual function, was maintained at 4 years (mean difference 0.77 points, p< 0.001). Overall, quality of life was similar between T treatment and control groups over the 4 years. No further study withdrawals or new safety concerns emerged although hematocrit and hemoglobin increased further over time with T treatment (P < 0.001).
In men with prediabetes or early T2DM, in the subgroup with continuing blinded T treatment for up to 4 years there were diminishing glycemic benefits and durable improvements in anthropometry and sexual desire, with an acceptable safety profile.
Wittert, G. et al. Lancet Diabetes Endocrinol 9, 32-45 (2021).
* In men with prediabetes or early T2DM, in the subgroup with continuing blinded T treatment for up to 4 years there were diminishing glycemic benefits and durable improvements in anthropometry and sexual desire, with an acceptable safety profile.
The T4DM trial found that in men aged 50 years and older with waist circumference (WC) ≥ 95cm and impaired glucose tolerance, 2 years treatment with testosterone (T) (vs placebo) together with a lifestyle program reduced the risk of type 2 diabetes (T2DM) diagnosis at 2 years by 40% compared with a lifestyle program alone (1). This effect was associated with a greater reduction in fat mass, increased skeletal muscle mass and strength and improved sexual function.
To evaluate the durability of T treatment effects on glycemia, anthropometry, sexual function, quality of life, and safety over four years, the T4DM RUNON sub-study extended the T4DM randomized, double-blind, placebo-controlled trial (n=1007) by 2 years, for a total of up to 4 years of treatment, without ongoing enrolment in the lifestyle program. Eligible and consenting participants (n=121) continued their original masked allocation to intramuscular testosterone undecanoate (1000mg 3 monthly) or placebo. Primary outcomes were glycemia (2-hour OGTT and fasting plasma glucose). Secondary outcomes included anthropometry, sexual function (IIEF), health-related quality of life (SF36), and safety measures.
The effect of T treatment on glycemia over 4 years was sustained as measured by mean difference in 2-hr OGTT glucose ( –1.0 mmol/L, 95% CI –1.7 to –0.88); fasting plasma glucose (–0.26 mmol/L, 95% CI –0.49 to –0.03) with most benefit in the first 2 years. For the proportion with 2-hr OGTT >11.1mmol/L a significant treatment effect at 2-years (P=0.27), was absent at 4-years (P=0.5). The 4-year adjusted mean differences in weight and WC between the T and placebo groups were -1.3kg (95% CI: -4.8 to 2.2) and –2.3cm (95%CI: -5.4 to 0.7), respectively. Most benefit occurred within the first 2 years. The improvement in sexual desire at 2 years, but not of other domains of sexual function, was maintained at 4 years (mean difference 0.77 points, p< 0.001). Overall, quality of life was similar between T treatment and control groups over the 4 years. No further study withdrawals or new safety concerns emerged although hematocrit and hemoglobin increased further over time with T treatment (P < 0.001).
In men with prediabetes or early T2DM, in the subgroup with continuing blinded T treatment for up to 4 years there were diminishing glycemic benefits and durable improvements in anthropometry and sexual desire, with an acceptable safety profile.
Wittert, G. et al. Lancet Diabetes Endocrinol 9, 32-45 (2021).
