Effect of Testosterone replacement on glycaemic control and insulin sensitivity in hypogonadal men with type 2 diabetes

ISRCTN ISRCTN57267165
DOI https://doi.org/10.1186/ISRCTN57267165
Secondary identifying numbers N0034128967
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
12/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr TH Jones
Scientific

Medicine
Barnsley District General Hospital NHS Trust
Gawber Road
Barnsley
S75 2EP
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesTo assess the effect of testosterone on glycaemic control and insulin sensitivity in type 2 diabetic men with hypogonadism.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNutritional, Metabolic, Endocrine: Hypogonadism
InterventionTestosterone replacement vs placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Testosterone
Primary outcome measureEfficacy of testosterone replacement
Secondary outcome measuresNot provided at time of registration
Overall study start date01/02/2003
Completion date31/07/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexMale
Target number of participants20 male patients
Key inclusion criteriaDiabetic men above 30 yrs old with hypogonadism
Key exclusion criteriaHormone manipulating therapy, inflammatory disease, infection, prostate carcinoma, elevated PSA
Date of first enrolment01/02/2003
Date of final enrolment31/07/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Medicine
Barnsley
S75 2EP
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Barnsley Hospital NHS Foundation Trust (UK), BDGH Small Projects Fund (internal funding)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2006 Yes No