| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN07197979 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0034170256 |
| Public title | Testosterone Replacement in Diabetes Mellitus with Vascular Disease |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Nutritional, Metabolic, Endocrine: Diabetes |
| Study hypothesis | To the effect 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, Peripheral Vascular Disease and hypogonadism. |
| Design/methodology | Single centre randomised double blind placebo controlled parallel study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/10/2005 |
| Anticipated end date | 01/06/2006 |
| Status of trial | Completed |
| Target number of participants | 30 |
| Interventions | Sustanon vs placebo |
| Primary outcome measure(s) | 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 outcome measure(s) | The effects of testosterone on Glycated Haemoglobin. |
| Sources of funding | Barnsley Hospital NHS Foundation Trust
|
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr TH Jones |
| Contact details | Medicine
Barnsley District General Hospital NHS Trust
Gawber Road
Barnsley
United Kingdom
S75 2EP |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN07197979 |
| Date last extracted from ISRCTN register | 17/04/2008 |
