NCT03792321

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

Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: Male
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Studies have shown that approximately 50 % of older obese males, who are being treated for diabetes mellitus type 2, also exhibit low testosterone levels. Hypogonadism negatively affects glycemic control, exacerbates early cardio-vascular disease, causes osteoporosis, erectile disfunction, reduces lean body mass, accelerates the accumulation of visceral fat and leads to obesity. Patients with diabetes mellitus type 2 and confirmed hypogonadism were enrolled into this randomized, double-blind, placebo-controlled clinical study. Placebo group patients were receiving placebo throughout the first year of this study and Testosterone group patients were receiving testosterone undecanoate during first year. Both groups were receiving testosterone undecanoate throughout the second year of this study.

Conditions

• Hypogonadism, Male
• Diabetes Mellitus, Type 2
• Obesity

Interventions

Type	Name	Description
DRUG	Testosterone Undecanoate	1000 mg i.m. every 10 weeks
DRUG	Placebo

Timeline

• Start date: 2014-01-10
• Primary completion: 2015-03-05
• Completion: 2018-03-05
• First posted: 2019-01-03
• Last updated: 2019-01-04