Testosterone Therapy of Men With Type 2 Diabetes Mellitus (T2DM)
NCT ID: NCT01560546
Last Updated: 2013-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
43 participants
INTERVENTIONAL
2012-03-31
2013-11-30
Brief Summary
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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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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Testim
Testosterone
50 mg/dose/day for 24 weeks
Placebo
Placebo for 24 weeks
Placebo
placebo on the skin for 24 weeks
Interventions
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Testosterone
50 mg/dose/day for 24 weeks
Placebo
placebo on the skin for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bioavailable testosterone \< 7,3 nmol/L
* Metformin treatment of T2DM for 3 months or more
Exclusion Criteria
* 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.
50 Years
70 Years
MALE
No
Sponsors
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Odense University Hospital
OTHER
Marianne Andersen
OTHER
Responsible Party
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Marianne Andersen
MD, ph.d.
Principal Investigators
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Marianne Andersen, MD, ph.d.
Role: PRINCIPAL_INVESTIGATOR
Locations
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Department of Endocrinology, Odense University Hospital
Odense, , Denmark
Countries
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References
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Botha J, Velling Magnussen L, Nielsen MH, Nielsen TB, Hojlund K, Andersen MS, Handberg A. Microvesicles Correlated with Components of Metabolic Syndrome in Men with Type 2 Diabetes Mellitus and Lowered Testosterone Levels But Were Unaltered by Testosterone Therapy. J Diabetes Res. 2017;2017:4257875. doi: 10.1155/2017/4257875. Epub 2017 Jan 12.
Other Identifiers
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2011-002102-73
Identifier Type: -
Identifier Source: org_study_id