Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients W… (NCT01084369) | Clinical Trial Compass
TerminatedPhase 4
Effect of Testosterone on Endothelial Function and Microcirculation in Type 2 Diabetic Patients With Hypogonadism
Stopped: Withdrawal of sponsorship
United Kingdom22 participantsStarted 2013-10-11
Plain-language summary
Diabetes mellitus is associated with long-term complications affecting mainly the eyes, nerves and kidneys. One of the main underlying causes for this is damage to the lining of the small blood vessels supplying these organs with dysfunction of the endothelium (lining of the small blood vessels). Testosterone has been shown to have an effect macro (large) blood vessels with limited data available on the micro (small) blood vessels. Testosterone is recognised to have important effects on metabolism and vascular behaviour beyond the accepted effects on secondary sexual characteristics. Physiological testosterone therapy is associated with some beneficial effects on the cardiovascular system and has been used with some success to treat patients with stable angina and chronic heart failure. The investigators therefore propose to study the effects of testosterone replacement therapy in patients with hypogonadism (low testosterone levels) on the endothelium in males with type 2 diabetes. 40 diabetic patients with type 2 diabetes and low testosterone levels and erectile dysfunction (impotence) will be recruited into the study. All patients will receive testosterone replacement therapy and 10 patients will also receive Vardenafil (a drug used to treat impotence). The investigators hope to demonstrate an improvement in endothelial dysfunction by assessing biochemical markers such as nitric oxide (a chemical that causes relaxation for the blood vessels) and C-reactive protein (a chemical that can increase in patients with diabetes) as well as the effect on weight, blood pressure, diabetes control and cholesterol.
Who can participate
Age range
50 Years – 80 Years
Sex
MALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 40 male patients with type 2 diabetes mellitus.
* T2DM as judged by WHO criteria:
* onset of diabetes mellitus after the age of 30 years
* blood glucose controlled by diet or drugs other than insulin, or insulin initiated after 2 years diagnosis of diabetes
* no history of diabetic ketoacidosis.
* Symptomatic Hypogonadism as defined by:
* Total testosterone below 10 nmol/l
* Aging males' symptom score (AMS) above 36.
* Hypogonadic men with erectile dysfunction
* Age range- 50-80 years
Exclusion Criteria:
* Patients with uncontrolled hypertension (BP\>145/95 on treatment) or significant hypotension. (BP\<100 systolic)
* Current smokers
* Recent myocardial infarction (\<6 months), unstable angina or ongoing chest pain, recent (within 6 months) cardiac intervention (e.g. angioplasty, stenting or CABG) or stroke.
* Patients with clinical nephropathy (24 hr protein \>0.5 g or urine protein +) or moderate renal failure (serum creatinine \>150 micromol/l).
* History of prostate cancer or suspicion of prostate cancer on clinical examination
* Androgen dependent carcinoma of the male mammary gland
* Liver tumours
* Hypersensitivity to NEBIDO or LEVITRA
* Polycythaemia
* General systemic illness, including cardiac, renal or hepatic insufficiency
* Patients on nitrates will not be included in the Levitra arm.
* History of loss of vision in one eye because of non arteritic ischaemic optic neuropathy (NAION), regardless of whether this episode was in c…
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
Improvement in endothelial dependent and endothelial-independent vasodilatation