Testosterone Therapy in Men With Low Testosterone Levels and Metabolic Syndrome or Early Stages o… (NCT00479609) | Clinical Trial Compass
UnknownPhase 3
Testosterone Therapy in Men With Low Testosterone Levels and Metabolic Syndrome or Early Stages of Type 2 Diabetes
Sweden176 participantsStarted 2007-04
Plain-language summary
Men with metabolic syndrome often have lower than normal testosterone levels and low testosterone levels have been suggested to predispose for development of type2 diabetes. The aim of the study is to evaluate if normalisation of serum testosterone levels in men with metabolic syndrome (Abdominal obesity, hypertension, dyslipidemia, insulin resistance and pre-diabetes or overt type diabetes)improves sensitivity to insulin and improves the signs of the metabolic syndrome
Who can participate
Age range30 Years – 70 Years
SexMALE
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Inclusion criteria
✓. Male 30 to 70 years (inclusive)
✓. Metabolic syndrome defined according to the International Diabetes Foundation (IDF):
✓. Abdominal obesity (waist circumference \> 94 cm for European men) and any two of the following criteria
✓. Triglycerides \> 1.7 mmol/L or specific treatment for this
✓. HDL \< 1.03 nmol/L or specific therapy for this
✓. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg or treatment for this.
✓. Fasting plasma glucose ≥ 5.6 mmol/L (venous glucose ≥ 6.1 mmol/L) or previously diagnosed type 2 diabetes mellitus defined by: Fasting plasma glucose ≥ 7.8 mmol/L on two occasions, or random glucose ≥ 11.1 mmol/L and classic symptoms of type 2 diabetes
✓. Impaired glucose tolerance If the definition of the metabolic syndrome, as described above, is fulfilled but fasting plasma glucose ≤ 5.6 mmol/L (fasting venous glucose is \< 6.1 mmol/L) the result of an oral glucose tolerance test must be classified as reduced glucose tolerance with a venous blood glucose 7.8 - 11.1 mmol/L or higher 120 min after intake of 75 g of glucose in a water solution (2h OGTT) (www.diabetes.org/main/info/pre-diabetes.jsp)
Exclusion criteria
✕. Ongoing pharmacological treatment of type 2 diabetes except for metformin.
✕. Use of androgen therapy or anabolic steroids within 6 months of entry into the study.