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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]Accessed by DXA scanning
- Insulin sensitivity [ Time Frame: three years ] [ Designated as safety issue: No ]Euglycemic hyperinsulinaemic clamp
- Regional body composition and liver fat [ Time Frame: three years ] [ Designated as safety issue: Yes ]DXA- and MR-scans and spect
- Glucose and lipid oxidation [ Time Frame: three years ] [ Designated as safety issue: No ]Indirect calorimetry
- Myostatin and satellite cells [ Time Frame: 8 years ] [ Designated as safety issue: No ]Muscle biopsy
- Inflammation [ Time Frame: 8 years ] [ Designated as safety issue: No ]Hormones: Adiponectin, leptin osteoprotegerin, IGF-I, bioactive IGF-I, Urine cortisol and steroid metabolites etc.
- Physical activity [ Time Frame: three years ] [ Designated as safety issue: No ]Questionaires
- Quality of life [ Time Frame: three years ] [ Designated as safety issue: No ]Questionaires
- Sexual function [ Time Frame: Three years ] [ Designated as safety issue: No ]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
Other Name: Placebo
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.
|Department of Endocrinology, Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Marianne Andersen, MD, ph.d.|