OPEN Research Support

Line Velling Magnussen
Department of Endocrinology, Esbjerg Hospital

Projekt styring
Projekt status    Sampling finished
Data indsamlingsdatoer
Start 01.04.2012  
Slut 20.11.2013  

Testosterone therapy of men with type 2 diabetes mellitus - a randomized, double-blinded, placebo-controlled trial

Short summary

The aim of the study was to contribute to the clarification of the beneficial and potential harmful effects of Testosterone replacement therapy (TRT) in aging men with type 2 diabetes mellitus (T2D) and testosterone levels (T-levels).


The prevalence of chronic diseases including obesity and type 2 diabetes mellitus (T2D) are increasing. In developed countries, the majority of all deaths are caused by chronic disease. Studies indicate that 80% of early heart disease and T2D can be prevented. Prevention of T2D and new treatment modalities are therefore essential.

Testosterone replacement therapy (TRT) has escalated in the Western countries during the past decades especially in aging men without clear organic indication for TRT. However, who to treat has not been clarified and the safety of long-term TRT regarding the risk of cardiovascular disease (CVD) is unknown. Aging men with T2D often have lowered testosterone levels (T-levels), ectopic fat depots, a deranged adipokine profile with e.g. low adiponectin levels, hyperleptinaemia, and an increased risk of CVD. The causal relations are unclear, and lowered T-levels could simply be a marker of illness, i.e. T2D and obesity.

TRT improves body composition with an increased total lean body mass (LBM) and a reduction in total fat mass (TFM) which may be of further benefit in aging men with T2D as this improved body composition, in theory, may ameliorate the insulin resistance in T2D, reduce ectopic fat, improve a deranged adipokine secretion, and advance physical strength and function. This project will contribute to the clarification of the beneficial and potential harmful effects of TRT in aging men with T2D and lowered T-levels. No previous randomized, double-blinded, placebo-controlled study in aging men with T2D has ever evaluated the effect of TRT applying only gold-standard methods such as mass spectrometry, whole-body Dual-energy X-ray Absorptiometry (DXA), euglycemic-hyperinsulinemic clamp, and Magnetic Resonance Spectroscopy (MRS) in patients with T2D on one stable anti-diabetic treatment.

Description of the cohort

White men, aged 50-70 years, with bioavailable testosterone (BioT) levels <7.3 nmol/L, a diagnosis of type 2 diabetes mellitus (T2D) within the preceding 3 months to 10 years, and receiving metformin for >3 months were eligible for inclusion. The cut-off limit for BioT (<7.3 nmol/L) was equivalent to the 2.5 percentile of the 95% confidence interval for the lower limit of BioT in healthy, non-obese, young (20-29 years) men. Patients were recruited using advertisements in newspapers, magazines, at general practitioners, and through written invitations to patients with newly diagnosed T2D, who were referred to our department. 

Data and biological material

Questionnaires, blood, urine, muscle and fat biopsies.