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Published-Ahead-of-Print July 3, 2009, DOI:10.2164/jandrol.108.007005

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52-Week Treatment with Diet and Exercise Plus Transdermal Testosterone Reverses the Metabolic Syndrome and Improves Glycaemic Control in Men with Newly Diagnosed Type 2 Diabetes and Subnormal Plasma Testosterone

Armin E Heufelder , Farid Saad , Mathijs C Bunck , and Louis J Gooren *

* To whom correspondence should be addressed. E-mail: louisjgooren{at}gmail.com.

Men with the metabolic syndrome (MetS) and type 2 diabetes (T2D) often have low testosterone levels. Elevating low testosterone levels may improve features of the MetS and glycemic control. In a single blind, 52-week randomized clinical trial, the effects of supervised diet and exercise (D&E) with or without transdermal testosterone administration on components of the MetS in hypogonadal men with the MetS and newly diagnosed T2D were assessed. 32 hypogonadal men (total testosterone <12.0 nmol/L) with the MetS as defined by the Adult Treatment Panel-III and the International Diabetes Federation, and newly diagnosed T2D received supervised D&E but 16 in combination with testosterone gel 50 mg once daily (n=16). No glucose lowering agents were administered prior to or during the study period. Outcome measures were components of the MetS as defined by the ATPIII and IDF. Serum testosterone, HbA1c, fasting plasma glucose, HDL-cholesterol, and triglyceride concentrations, and the waist circumference improved in both treatment groups after 52-weeks of treatment. Addition of testosterone significantly further improved these measures compared to D&E alone. All D&E+T patients reached the HbA1c goal of <7.0%, 87.5% reached an HbA1c <6.5%. Based on ATPIII, 81.3% of the patients randomized to D&E+T no longer matched the criteria of the MetS, whereas 31.3% of the D&E alone patients did. Additionally, testosterone treatment improved insulin sensitivity, adiponectin and high-sensitivity C-reactive protein. Addition of testosterone to supervised D&E results in greater therapeutic improvements of glycaemic control and reverses the MetS after 52-weeks of treatment in hypogonadal patients with the MetS and newly diagnosed T2D.


Key words: Androgen • Andropause • diabetes mellitus type2 • metabolic syndrome • testosterone




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