Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)

• Status: Completed
• Trial end date: 2018-03-05
• Target enrollment: 0
• Participant gender: Male

Summary

Aim of the study was to investigate the effects of testosterone replacement therapy on components of metabolic syndrome, vascular function and morphology, grade of non-alcoholic fatty liver disease (NAFLD), bone mineral density (BMD) and health-related quality of life.

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

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• men aged > 35 years

• body mass index > 30 kg/m2

• confirmed hypogonadism

• type 2 diabetes mellitus treated with non-insulin therapy

Exclusion Criteria:

• previously treated hypogonadism

• the 2 diabetes mellitus treated with insulin therapy

• a history of current prostate or breast cancer

• severe benign prostatic hyperplasia

• elevated prostate-specific antigen (PSA > 4.0 lg/l)

• severe heart failure

• acute coronary event or procedure during the six months leading up to the study

• chronic obstructive lung disease

• hypothyroidism

• severe obstructive sleep apnea (OSA)

• active infection

• rheumatoid arthritis