Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)
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.
|Type 2 Diabetes Mellitus Hypogonadism||Drug: Testosterone Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.|
- Lean body mass [ Time Frame: approximately three years ]Accessed by DXA scanning
- Insulin sensitivity [ Time Frame: three years ]Euglycemic hyperinsulinaemic clamp
- Regional body composition and liver fat [ Time Frame: three years ]DXA- and MR-scans and spect
- Glucose and lipid oxidation [ Time Frame: three years ]Indirect calorimetry
- Myostatin and satellite cells [ Time Frame: 8 years ]Muscle biopsy
- Inflammation [ Time Frame: 8 years ]Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc.
- Physical activity [ Time Frame: three years ]Questionaires
- Quality of life [ Time Frame: three years ]Questionaires
- Sexual function [ Time Frame: Three years ]Questionaires
|Study Start Date:||March 2012|
|Study Completion Date:||November 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Testim||
50 mg/dose/day for 24 weeks
Other Name: Testim
Placebo Comparator: Placebo
Placebo for 24 weeks
placebo on the skin for 24 weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560546
|Department of Endocrinology, Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Marianne Andersen, MD, ph.d.|