Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM) - a Randomised, Doubleblinded and Placebocontrolled Trial of Men With Subnormal Testosterone Levels and T2DM.

Conditions
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Type 2 Diabetes Mellitus, Hypogonadism

Intervention / Treatment
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* Drug: Testosterone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male gender age 50-70 Bioavailable testosterone < 7,3 nmol/L Metformin treatment of T2DM for 3 months or more Exclusion Criteria: HbA1c > 9,0 %, BMI > 40 kg/m2, Haematocrit > 50%, Known malignant disease, PSA > 3 ug/L, Nycturia > 3 times, Abnormal routine blood samples, Severe hypertension, Significant EKG-changes, Wish of parenthood, Active mental illness, former or present abuse, Severe illness of heart-, lung- or kidney, Primary or secondary hypogonadism.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Testim<br> | Drug: Testosterone<br>* 50 mg/dose/day for 24 weeks<br>* Other names: Testim;|
| Placebo Comparator: Placebo<br>Placebo for 24 weeks | Drug: Placebo<br>* placebo on the skin for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean body mass | Accessed by DXA scanning | approximately three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |