NCT01560546

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Marianne Andersen · Academic / Other
• Sex: Male
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Type 2 Diabetes Mellitus
• Hypogonadism

Interventions

Type	Name	Description
DRUG	Testosterone	50 mg/dose/day for 24 weeks
DRUG	Placebo	placebo on the skin for 24 weeks

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-05-01
• Completion: 2013-11-01
• First posted: 2012-03-22
• Last updated: 2013-11-14

Locations

1 site across 1 country: Denmark