Testosterone Replacement in Diabetes Mellitus with Vascular Disease

ISRCTN	ISRCTN07197979
DOI	https://doi.org/10.1186/ISRCTN07197979
Secondary identifying numbers	N0034170256

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

Study design	Single centre randomised double blind placebo controlled parallel study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nutritional, Metabolic, Endocrine: Diabetes
Intervention	Sustanon vs placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Sustanon
Primary outcome measure	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.
Secondary outcome measures	The effects of testosterone on Glycated Haemoglobin.
Overall study start date	01/10/2005
Completion date	01/06/2006

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	30
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/10/2005
Date of final enrolment	01/06/2006

Medicine

Barnsley
S75 2EP
United Kingdom

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Barnsley Hospital NHS Foundation Trust (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2007		Yes	No