The metabolic syndrome constitutes a cluster of risk factors for cardiovascular disease with increased morbidity and mortality. The metabolic syndrome is referred to as a concomitant occurrence of hypertension, hyperlipidemia, impaired glucose tolerance with insulin resistance and abdominal obesity. . MedDRA version: 8.1 Level: LLT Classification code 10052066 Term: Metabolic syndrome
Conditions
Interventions
Trade Name: Testogel 25mg, gel in sachet
Pharmaceutical Form: Gel
INN or Proposed INN: Testosterone
CAS Number: 58220
Concentration type: equal
Concentration number: 25 mg-
Pharmaceutical form of the
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male 30 to 70 years (inclusive) 2. Metabolic syndrome defined according to the International Diabetes Foundation (IDF): a) Abdominal obesity (waist circumference > 94 cm for European men) and any two of the following criteria b) Triglycerides > 1.7 mmol/L or specific treatment for this c) HDL =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Insulin therapy and therapy with glitazones. 2. Use of androgen therapy or anabolic steroids within 6 months of entry into the study. 3. Known congestive heart failure, progressing angina pectoris or a history of myocardial infarction within the last 12 months. 4. Known untreated pituitary disease. 5. A history of significant renal or liver disease or any malignancy. 6. Any disease requiring long-term use of drugs interfering with androgens; spironolactone, Ketoconazol, corticosteroids, cimetidin, fentiazines, tricyclic antidepressives, anabolic steroids, 5-alfa reductase inhibitors, antiestrogens. 7. Prostate Specific Antigen (PSA) >= 4 ng/ml. 8. Suspected malignancy after prostata palpation, unless biopsy shows the opposite. 9. Malignant tumour of the mammary gland 10. Ongoing micturition problem severely affecting patient’s daily living at the discretion of the investigators judged by the investigator. 11. Any contraindication for treatment with testosterone 1% hydroalchol gel according to the labelling as well as known or suspected allergy to the specific product used in the study. 12. Contagious blood disease. 13. Known alcohol or drug abuse, or any condition associated with poor compliance. 14. Participation in a clinical study during the last 90 days before start of treatment. 15. Previous enrolment or randomisation in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of testosterone treatment (1% testosterone hydroalcohol gel) compared to placebo, with respect to insulin resistance together with other circulatory and metabolic variables. ;Secondary Objective: Glycemic control and oral glucose tolerance and other metabolic variables of importance will also be evaluated, especially blood lipid levels and markers for cholesterol metabolism. will be evaluated by standardized laboratory measurements and visceral abdominal obesity will be assessed by anthropometric assessment and computerised tomography at three different levels of L3-L4 and the liver, the latter to reflect changes in lipid accumulation in the liver (steatosis). Furthermore adiponectin will be assessed.;Primary end point(s): The primary variable is a measure of insulin sensitivity and will be assessed by the calculation of insulin sensitivity by an index formula based on a homeostasis model of steady state levels of insulin and glucose in the fasting state (Wallace et al 2004). Of the varieties of methods and models the quantitative insulin-sensitivity check index (QUICKI) has been reported to have higher predictive value in estimating outcome of the golden standard for assessment of insulin sensitivity (hyperinsulinemic euglycemic glucose clamp) (Chen et al 2005). | — |
Countries
Austria, Germany, Sweden
Outcome results
None listed