Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)
Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.
Lead SponsorOdense University Hospital
StatusCompleted No Results Posted
Indication/ConditionType 2 Diabetes Mellitus Hypogonadism
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.
50 mg/dose/day for 24 weeks
placebo on the skin for 24 weeks
Placebo for 24 weeks
Inclusion Criteria: Male gender age 50-70 Bioavailable testosterone < 7,3 nmol/L Metformin treatment of T2DM for 3 months or more Exclusion Criteria: HbA1c > 9,0 %, BMI > 40 kg/m2, Haematocrit > 50%, Known malignant disease, PSA > 3 ug/L, Nycturia > 3 times, Abnormal routine blood samples, Severe hypertension, Significant EKG-changes, Wish of parenthood, Active mental illness, former or present abuse, Severe illness of heart-, lung- or kidney, Primary or secondary hypogonadism.