Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)
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|ClinicalTrials.gov Identifier: NCT01560546|
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : November 14, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Hypogonadism||Drug: Testosterone Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||November 2013|
|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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560546
|Department of Endocrinology, Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Marianne Andersen, MD, ph.d.|