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
Protocol serial number	N0034128967
Sponsor	Department of Health
Funder	Barnsley Hospital NHS Foundation Trust (UK), BDGH Small Projects Fund (internal funding)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr TH Jones
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To 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) studied	Nutritional, Metabolic, Endocrine: Hypogonadism
Intervention	Testosterone replacement vs placebo
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Testosterone
Primary outcome measure(s)	Efficacy of testosterone replacement
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target sample size at registration	20
Key inclusion criteria	Diabetic men above 30 yrs old with hypogonadism
Key exclusion criteria	Hormone manipulating therapy, inflammatory disease, infection, prostate carcinoma, elevated PSA
Date of first enrolment	01/02/2003
Date of final enrolment	31/07/2004

Medicine

Barnsley
S75 2EP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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