Clinical Trial Details
| Trial ID: | L3673 |
| Source ID: | NCT01560546 |
| Associated Drug: | Testosterone |
| Title: | Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus|Hypogonadism |
| Interventions: | DRUG: Testosterone|DRUG: Placebo |
| Outcome Measures: | Primary: Lean body mass, Accessed by DXA scanning, approximately three years | Secondary: Insulin sensitivity, Euglycemic hyperinsulinaemic clamp, three years|Regional body composition and liver fat, DXA- and MR-scans and spect, three years|Glucose and lipid oxidation, Indirect calorimetry, three years|Myostatin and satellite cells, Muscle biopsy, 8 years|Inflammation, Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc., 8 years|Physical activity, Questionaires, three years|Quality of life, Questionaires, three years|Sexual function, Questionaires, Three years |
| Sponsor/Collaborators: | Sponsor: Marianne Andersen | Collaborators: Odense University Hospital |
| Gender: | MALE |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 43 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2012-03 |
| Completion Date: | 2013-11 |
| Results First Posted: | |
| Last Update Posted: | 2013-11-14 |
| Locations: | Department of Endocrinology, Odense University Hospital, Odense, 5000, Denmark |
| URL: | https://clinicaltrials.gov/show/NCT01560546 |
