Non-alcoholic fatty liver disease (NAFLD) is emerging as a public health issue worldwide, is highly prevalent in patients with type 2 diabetes (T2D), and is linked to obesity, insulin resistance and atherogenic dyslipidemia. We aimed to evaluate effects of testosterone therapy (TTh) on morphology and grade of NAFLD in obese men with functional hypogonadism (FH) and T2D.
Research design and methods
55 obese males with FH and T2D participated in a two-year (first year double-blind, placebo-controlled study, second year follow-up) clinical trial. Total, calculated free and calculated bioavailable testosterone levels, fasting plasma glucose, glycated hemoglobin A1c, lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides), prostate specific antigen, routine blood tests (complete blood count, electrolytes, urea, creatinine, liver tests) were assessed at baseline, 12 and 24 months. Liver ultrasounds for NAFLD grade assessments were performed at the beginning and after two years. T-test and Wilcoxons signed rank were used to detect changes from baseline. Normality of distribution of data was assessed with ShapiroWilk test.
Participants were randomized into two groups. Group T (n = 28) received 1000 mg testosterone undecanoate (TU) both years of the study while group P (n = 27) received placebo first year and TU second year. Liver assessment showed improvement in NAFLD grades at statistically significant level (P <0.001) after two years of TRT. TTh normalized testosterone levels in both groups within first year and stayed in normal range after the second year of the study. No adverse events (prostate carcinoma, cardiovascular events) or side effects of TRT have been observed over the two-year course of this trial.
Two-year therapy with testosterone undecanoate normalized serum testosterone levels, reduced NAFLD grade, and quells the symptoms of hypogonadism in obese men with functional hypogonadism and T2D.
22 May 2021 - 26 May 2021