Testosterone replacement therapy in men with type 2 diabetes mellitus and neuropathy

Background. Testosterone replacement therapy (TRT) in elderly men with diabetes mellitus (DM) and obesity has a number of positive effects, such as weight loss, normalization of blood pressure and metabolic parameters. Objective. Evaluation of the efficacy of TRT on the course of diabetic polyneuropathy in men with a history of diabetic foot and age-related hypogonadism. Methods. The study included 49 men with type 2 diabetes mellitus (DM2) and a history of amputation at the foot level for diabetic foot. The total serum testosterone level initially ranged from 1.3 to 12 nmol/L., the testosterone level of 12 nmol/L was considered «borderline». Anthropometric, biochemical parameters, the results of clinical and neurological examination with Neuropathic Dysfunctional Score, as well as standard cardiovascular tests were assessed initially and 6 months after treatment. All patients were divided into two groups: the first (25 people) received TRT with testosterone Omnandren-250 (250 mg IM 1 time per week for 6 months); the second group (24 patients) received placebo. Results. Patients of both groups were comparable in age (57.2±1.99 and 55.5+1.07 years, respectively; p=0.57), diabetes duration (8.6+1.74 and 9.9+1, 34 years, respectively; p=0.57) and anthropometric parameters (body mass index [BMI] - 28.7+0.84 and 29.3+0.79; p=0.24). The HbA1c level was 7.6+0.25 and 8.3+0.22%, respectively (p=0.93). All patients had moderate or severe sensorimotor neuropathy. Moreover, severe cardiovascular autonomic neuropathy (CAN) occurred in 36 and 25% of cases, respectively; χ2=0.57; p=0.24). 6 months after treatment, only the patients of the first group, who received TRT, noted a decrease in the clinical symptoms of testosterone deficiency and an improvement in the quality of life. No changes in BMI, waist-to-hip ratio, metabolic parameters, as well as the results of a clinical neurological examination were observed in both groups. However, TRT improved the peripheral vasomotor response to cold stimulus (22.9+3.11 and 28.5+2.39% before and after treatment, respectively; p=0.029), and the response to the dynamometer test increased (9.1±1.12 and 10.4±1.48 mm Hg before and after treatment, respectively; p=0.04). As a result, restoration of the normal reaction to the test with passive orthostasis was recorded only in the group of TRT patients. Conclusion. The normalization of testosterone levels within a short period of time did not significantly affect the metabolic parameters of DM2 patients. However, only in the TRT group restoration of the normal reaction to the test with passive orthostasis and, as a consequence, regression of CAN severity was recorded.

type 2 diabetes mellitus, diabetic neuropathy, cardiovascular neuropathy, hypogonadism, testosterone replacement therapy