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ISRCTN
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ISRCTN07197979
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ClinicalTrials.gov identifier
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Public title
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Testosterone Replacement in Diabetes Mellitus with Vascular Disease
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0034170256
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Single centre randomised double blind placebo controlled parallel study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Nutritional, Metabolic, Endocrine: Diabetes
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/2005
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Anticipated end date
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01/06/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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30
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Interventions
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Sustanon vs placebo
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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The effects of testosterone on Glycated Haemoglobin.
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Sources of funding
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Barnsley Hospital NHS Foundation Trust
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Trial website
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Publications
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Contact name
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Dr
TH
Jones
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Address
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Medicine
Barnsley District General Hospital NHS Trust
Gawber Road
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City/town
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Barnsley
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Zip/Postcode
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S75 2EP
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2007 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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28/09/2007
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Last edited
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22/10/2007
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Date ISRCTN assigned
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28/09/2007
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