T treatment longer than 1 year shows more effects on FH and related metabolic, vascular, diabetic and obesity parameters

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Testosterone treatment longer than 1 year shows more effects on functional hypogonadism and related metabolic, vascular, diabetic and obesity parameters (results of the 2-year clinical trial)



ABSTRACT


Objective: We evaluated long-term effects of testosterone undecanoate on glycemic control, metabolic syndrome, vascular function, and morphology in obese men with functional hypogonadism (FH) and type 2 diabetes (T2D) in a 2-year prospective clinical trial.

Methods: A total of 55 participants were enrolled in this study; group P (n ¼ 27) received a placebo during first and testosterone therapy (TTh) during the second year, group T (n ¼ 28) received TTh both years. We pooled results after 1 year of TTh to obtain more statistical power. Results for group T after 2 years of TTh are also presented. We evaluated a wide assortment of biochemical (fasting plasma glucose—FPG, glycated hemoglobin—HbA1c and lipid profile), hormonal, vascular (flow-mediated dilatation—FMD and intima-media thickness—IMT), anthropometrical and derived parameters (BMI, HOMA-IR, non-HDL cholesterol, bioavailable and calculated free testosterone). Quality of life was assessed using the Aging Males’ Symptoms (AMS) questionnaire.

Results: FPG, HbA1c, HOMA-IR, and IMT decreased, FMD increased, lipid profile and AMS sexual sub-score improved, and testosterone levels fully normalized after 2 years of TTh.

Conclusions: Two-year of TTh resulted in normalized serum testosterone levels, improved glycemia, endothelial function, lipids, and insulin sensitivity, and quelled the symptoms of hypogonadism, potentially reducing cardiovascular risk in obese men with FH and T2D.







In conclusion, several cardiovascular risk factors have improved in obese men with FH and T2D after 2 years of TTh, most notably IR, components of atherogenic dyslipidemia and glycemic control, resulting in weight loss, improvement in endothelial function and vascular morphology. Testosterone affects these parameters differently in the long-term; some see further notable improvements with the continuation of TTh beyond 1 year (BMI, WC, HbA1c, triglycerides, LDL cholesterol, HDL cholesterol, and IMT). These findings, together with the therapeutic benefit of testosterone with regard to symptoms of hypogonadism, call for additional, longer-term studies on effects of TTh in obese males with FH and T2D.
 

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Table 1. Study population characteristics. Values reported as mean ± SD or as count (percentage)
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Table 2. Effects of testosterone treatment on parameters of metabolic syndrome after 12 months of testosterone replacement therapy—pooled results for both groups P and T (n ¼ 55).
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Table 3. Effects of testosterone treatment on parameters of metabolic syndrome after 24 months of therapy—results for group T (n ¼ 28).
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Figure 1. Pooled results of 1 year of TTh on glycated hemoglobin A1c (HbA1c), n ¼ 55.

Figure 2. Pooled results of 1 year of TTh on HOMA-IR, n ¼ 55.

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Figure 3. Pooled results of 1 year of TTh on non-HDL cholesterol, n ¼ 55.

Figure 5. Pooled results of 1 year of TTh on IMT of carotid arteries, n ¼ 55.

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Figure 4. Pooled results of 1 year of TTh on FMD of brachial artery, n ¼ 55.

Figure 6. Group T results of 2 years of TTh on glycated hemoglobin A1c (HbA1c), n ¼ 28.

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Figure 7. Group T results of 2 years of TTh on HOMAIR, n ¼ 28.

Figure 8. Group T results of 2 years of TTh on non-HDL cholesterol, n ¼ 28.

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Figure 9. Group T results of 2 years of TTh on FMD of brachial artery, n ¼ 28.
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Figure 10. Group T results of 2 years of TTh on IMT of carotid arteries, n ¼ 28.
Screenshot (1843).png
 
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