Nutritional, Metabolic, Endocrine: Diabetes Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
Sustanon vs placebo
Sponsors
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Men with Diabetes M, hypogonadism and PVD 2. Older than 40 years old 3.Type 2 Diabetes Mellitus treated with insulin with or without oral hypoglycaemics 4. Serum testosterone less than 12mmol/L on two consecutive morning samples taken on different days 5. Symptoms attributable to hypogonadism in the opinion of the investigator 6. Agreement to maintain, diabetic antihypertensive and antilipid treatments at prior doses for the duration of the study 7. Ability to give written informed consent and verbal and written explanation in the English language 8. Ability to comply with all study requirements
Exclusion criteria
Exclusion criteria: 1. Current or previous breast cancer 2. Current or previous prostate cancer 3. Raised prostate specific antigen (PSA) or abnormal digital rectal examination suspicious of prostate cancer unless diagnosis excluded after specialist urology opinion and/or prostate biopsy 4. Severe symptoms of benign prostatic hypertrophy (prostatism) 5. Treatment with testosterone in the 3 months prior to the trial. 6. Investigational drug treatment in the 3 months prior to the trial 7. Any other reason considered significant by the investigators at the time of assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effectiveness of 12 weeks of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on arterial stiffness measured by ultrasound derived stiffness index B of the femoral artery in men with a combination of Diabetes Mellitus, PVD and hypogonadism. | — |
Secondary
| Measure | Time frame |
|---|---|
| The effects of testosterone on Glycated Haemoglobin. | — |
Countries
United Kingdom
Outcome results
None listed