A randomized, placebo-controlled, double-blinded study on 40 men with type 2 DM. Type 2 diabetes mellitus (T2DM) is a common endocrine disorder characterized by hyperinsulinaemia and insulin resistance. Hypothesis Testosterone therapy increases lean body mass and insulin sensitivity in men with low normal levels of bioavailable testosterone and type 2 DM.
Background Inadequate levels of androgens have been associated with an increased risk of chronic illnesses including obesity and diabetes. Moreover, testosterone treatment has been shown to increase lean body mass and lipid oxidation as well as insulin sensitivity in hypogonadal men.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
50 mg/dose/day for 24 weeks
placebo on the skin for 24 weeks
Department of Endocrinology, Odense University Hospital
Odense, Denmark
Lean body mass
Accessed by DXA scanning
Time frame: approximately three years
Insulin sensitivity
Euglycemic hyperinsulinaemic clamp
Time frame: three years
Regional body composition and liver fat
DXA- and MR-scans and spect
Time frame: three years
Glucose and lipid oxidation
Indirect calorimetry
Time frame: three years
Myostatin and satellite cells
Muscle biopsy
Time frame: 8 years
Inflammation
Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc.
Time frame: 8 years
Physical activity
Questionaires
Time frame: three years
Quality of life
Questionaires
Time frame: three years
Sexual function
Questionaires
Time frame: Three years
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