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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marianne Andersen
• Collaborator: Odense University Hospital
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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.