Testosterone therapy of patients with type 2 diabetes mellitus

Conditions: Type 2 diabetes mellitus (T2DM) is a common endocrine disorder caracterized by hyperinsulinaemia and insulin resistance. We aim to investigate if testosterone therapy can improve body composition, insulin sensitivity, lipid metabolism and quality of life in men with low to normal bioavailable testosterone levels (<7.3 nmol/l) and T2DM.
MedDRA version: 14.1Level: LLTClassification code 10043368Term: Testosterone decreasedSystem Organ Class: 10022891 - Investigations
MedDRA version: 14.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2011-002102-73-DK

Lead Sponsor: Endokrinologisk afd. M

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

Inclusion Criteria

All participating patients have to give a spoken and written informed consent. 1) Man 50-70 years of age 2) Type 2 DM diagnosed within the last 10 years 3) Metformin treated type 2 DM >= 3 months 4) Bioavailable testosterone levels < 7.3 nmol/L
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

HbA1c = 9,0 %, BMI = 40 kg/m2, Hæmatokrit > 50%, Known malignant disease, PSA > 3 ug/L, Nykturi > 3 times, Abnormal rutine blodsamples, Severe hypertension, Significant EKG-changes, Wish of parenthood, Active mental illness, present or former abuse within one year, Severe ilness of heart-, lung- or kidney, Primary or secondary hypogonadisme.