Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0034128967
Study information
Scientific title
Acronym
Study hypothesis
To assess the effect of testosterone on glycaemic control and insulin sensitivity in type 2 diabetic men with hypogonadism.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Hypogonadism
Intervention
Testosterone replacement vs placebo
Intervention type
Drug
Phase
Not Specified
Drug names
Testosterone
Primary outcome measure
Efficacy of testosterone replacement
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2003
Overall trial end date
31/07/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Diabetic men above 30 yrs old with hypogonadism
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
20 male patients
Participant exclusion criteria
Hormone manipulating therapy, inflammatory disease, infection, prostate carcinoma, elevated PSA
Recruitment start date
01/02/2003
Recruitment end date
31/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medicine
Barnsley
S75 2EP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Barnsley Hospital NHS Foundation Trust (UK), BDGH Small Projects Fund (internal funding)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16728551
Publication citations
-
Results
Kapoor D, Goodwin E, Channer KS, Jones TH, Testosterone replacement therapy improves insulin resistance, glycaemic control, visceral adiposity and hypercholesterolaemia in hypogonadal men with type 2 diabetes., Eur. J. Endocrinol., 2006, 154, 6, 899-906, doi: 10.1530/eje.1.02166.