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ISRCTN
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ISRCTN57267165
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ClinicalTrials.gov identifier
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Public title
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Effect of Testosterone replacement on glycaemic control and insulin sensitivity in hypogonadal men with type 2 diabetes
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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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N0034128967
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Study hypothesis
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To assess the effect of testosterone on glycaemic control and insulin sensitivity in type 2 diabetic men with hypogonadism.
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Lay summary
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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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Randomised controlled trial
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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: Hypogonadism
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Participants - inclusion criteria
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Diabetic men above 30 yrs old with hypogonadism
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Participants - exclusion criteria
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Hormone manipulating therapy, inflammatory disease, infection, prostate carcinoma, elevated PSA
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Anticipated start date
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01/02/2003
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Anticipated end date
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31/07/2004
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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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20 male patients
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Interventions
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Testosterone replacement vs placebo
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Primary outcome measure(s)
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Efficacy of testosterone replacement
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Barnsley Hospital NHS Foundation Trust (UK), BDGH Small Projects Fund (internal funding)
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16728551
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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 - 2005 Update - Department of Health (UK)
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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 (0)20 7307 2623
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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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30/09/2005
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Last edited
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12/11/2008
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Date ISRCTN assigned
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30/09/2005
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