Status:
COMPLETED
Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Hypogonadism, Male
Diabetes Mellitus, Type 2
Eligibility:
MALE
35+ years
Phase:
PHASE4
Brief 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 (N...
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 cont...
Eligibility Criteria
Inclusion
- men aged \> 35 years
- body mass index \> 30 kg/m2
- confirmed hypogonadism
- type 2 diabetes mellitus treated with non-insulin therapy
Exclusion
- 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
Key Trial Info
Start Date :
January 10 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2018
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03792321
Start Date
January 10 2014
End Date
March 5 2018
Last Update
January 4 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.