Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SE… (NCT03792321) | Clinical Trial Compass
CompletedPhase 4
Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)
55 participantsStarted 2014-01-10
Plain-language 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.
Who can participate
Age range
35 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effects of testosterone replacement therapy on glycemic control - fasting plasma glucose (FPG) mmol/l
Timeframe: FPG was measured at baseline, after 12 months and after 24 months
2
Effects of testosterone replacement therapy on glycemic control - glycated hemoglobin A1c (HbA1c) %
Timeframe: HbA1c was measured at baseline, after 12 months and after 24 months
3
Effects of testosterone replacement therapy on parameters of metabolic syndrome - change in HOMA-IR
Timeframe: HOMA-IR was calculated at the baseline, after 12 months and after 24 months of clinical trial.
4
Effects of testosterone replacement therapy on vascular function - change in flow mediated dilatation (FMD) %
Timeframe: FMD was measured at baseline, after 12 months and after 24 months
5
Effects of testosterone replacement therapy on vascular morphology - intima-media thickness (IMT)
Timeframe: IMT was measured at baseline, after 12 months and after 24 months