Testosterone for Men With Insulin Treated Type 2 Diabetes
A Randomised Double Blind Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Replacement on Glycaemic Control and Arterial Wall Properties of Hypogonadal Men With Type 2 Diabetes Treated With Insulin
Sponsor: Barnsley Hospital
This PHASE4 trial investigates Diabetes and Hypogonadism and is currently completed. Barnsley Hospital leads this study, which shows 6 recorded versions since 2006 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)There is epidemiological data linking low serum testosterone levels in men with the development of diabetes. Clinical trials have indicated a potential benefit of testosterone treatment in improving diabetic control and insulin resistance. Type 2 diabetes is also associated with changes in arterial stiffness and IMT which are known to be linked to the presence of cardiovascular disease. Artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot study is to test the effect of six months of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on diabetes control in hypogonadal men with type 2 diabetes treated with insulin.
There is epidemiological data linking low serum testosterone levels in men with the development of diabetes. Clinical trials have indicated a potential benefit of testosterone treatment in improving diabetic control and insulin resistance. Type 2 diabetes is also associated with changes in arterial stiffness and IMT which are known to be linked to the presence of cardiovascular disease. Artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot study is to test the effect of six months of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on diabetes control in hypogonadal men with type 2 diabetes treated with insulin.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE4
-
Sep 2024 — Present [monthly]
Completed PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE4
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE4
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE4
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE4
First recorded
Jul 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Barnsley Hospital
For direct contact, visit the study record on ClinicalTrials.gov .